A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis

The purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).

Start Date11 Sep 2024

Sponsor / Collaborator

Priovant Therapeutics, Inc.

NCT06433999 / Not yet recruitingPhase 2

A 12-Week Open-Label Pilot Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Skin-Predominant Dermatomyositis

This is a prospective, 12-week, open-label, single-arm study. The study population comprises individuals with refractory skin disease characteristic of dermatomyositis with no to minimal muscle involvement. After an up to 8-week Screening Period, eligible participants will receive brepocitinib 30 mg orally (PO) QD for 12 weeks.

Start Date01 Aug 2024

Sponsor / Collaborator

Priovant Therapeutics, Inc.

NCT05523765 / Active, not recruitingPhase 2

A Phase 2 Randomized, Double-Masked, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active Non-Infectious Intermediate-, Posterior-, and Panuveitis

This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with active intermediate, posterior, or pan non-infectious uveitis (NIU).

Start Date14 Nov 2022

Sponsor / Collaborator

Priovant Therapeutics, Inc.

100 Clinical Results associated with Brepocitinib

100 Translational Medicine associated with Brepocitinib

100 Patents (Medical) associated with Brepocitinib

Literatures (Medical) associated with Brepocitinib

01 Oct 2024·Journal of the American Academy of Dermatology

A phase 2a trial of brepocitinib for cicatricial alopecia

Article

Author: Da Rosa, Joel Correa ; Peeva, Elena ; David, Eden ; Bose, Swaroop ; Mahling, Ping ; Del Duca, Ester ; Guttman-Yassky, Emma ; Hawkins, Kelly ; Pulsinelli, Juliana ; Ungar, Benjamin ; Oemar, Barry ; Singer, Giselle ; Estrada, Yeriel ; Meariman, Marguerite ; Shokrian, Neda ; Sikand, Savina ; Dubin, Celina ; Andrews, Elizabeth

BACKGROUNDCicatricial alopecias (CA) are chronic, progressive scarring hair-loss conditions. Molecular dysregulation is not fully understood, hindering treatment development. Th1/IFNγ signaling and JAK dysregulation has shown involvement, providing rationale for this phase 2a trial with TYK2/JAK1 inhibitor brepocitinib.METHODSRandomized, placebo-controlled phase 2a trial spanning 52 weeks. Adults (18≥years of age) with lichen planopilaris, frontal fibrosing alopecia, or central centrifugal cicatricial alopecia diagnosis were randomized 3:1 to brepocitinib 45mg daily or placebo for 24 weeks, after which all patients received brepocitinib for another 24 weeks, with a safety follow up 4 weeks later. Lesional scalp biopsies were collected at baseline, week 24, and week 48. Co-primary endpoints were changes in lesional expression of CCL5, changes in lesional expression of fibrosis-related markers, and safety at week 24.RESULTSPatients receiving brepocitinib showed significant downregulation in CCL5 expression at week 24 (p=0.004). Enrichment analysis of a subset of fibrosis markers showed trending upregulation in placebo patients (p<0.1). Brepocitinib was well tolerated and improved clinical severity scores.LIMITATIONSSingle-dose regimen, small placebo group.CONCLUSIONBrepocitinib significantly reduces CCL5 expression and was well tolerated at week 24, meeting co-primary endpoints. Brepocitinib reduces inflammatory biomarker expression and improves clinical severity, while maintaining favorable safety profile.

01 Sep 2024·Molecular Neurobiology

Janus Kinase Inhibitor Brepocitinib Rescues Myelin Phagocytosis Under Inflammatory Conditions: In Vitro Evidence from Microglia and Macrophage Cell Lines

Article

Author: Romero-Ramírez, Lorenzo ; García-Rama, Concepción ; Mey, Jörg

Central nervous system (CNS) injuries induce cell death and consequently the release of myelin and other cellular debris. Microglia as well as hematogenous macrophages actively collaborate to phagocyte them and undergo their degradation. However, myelin accumulation persists in the lesion site long after the injury with detrimental effects on axonal regeneration. This might be due to the presence of inhibitors of phagocytosis in the injury site. As we recently published that some proinflammatory stimuli, like interferon-γ (IFNγ) and lipopolysaccharide (LPS), inhibit myelin phagocytosis in macrophages, we have now studied the signaling pathways involved. A phagocytosis assay in Raw264.7 macrophages and N13 microglia cell lines with labeled myelin was developed with the pHrodo reagent that emits fluorescence in acidic cellular compartments (e.g.lysosomes). Pharmacological inhibition of Janus kinases (Jak) with Brepocitinib restored myelin phagocytosis and rescued the expression of genes related to phagocytosis, like triggering receptor expressed on myeloid cells 2 (TREM2), induced by IFNγ or LPS. In addition, while pharmacological inhibition of the signal transducer and activator of transcription 3 (STAT3) rescued myelin phagocytosis and the expression of phagocytosis related genes in the presence of LPS, it did not have any effect on IFNγ-treated cells. Our results show that Jak pathways participate in the inhibition of myelin phagocytosis by IFNγ and LPS. They also indicate that the resolution of inflammation is important for the clearance of cellular debris by macrophages and subsequent regenerative processes.

01 Jul 2024·Drug Metabolism and Disposition

The Metabolism and Disposition of Brepocitinib in Humans and Characterization of the Formation Mechanism of an Aminopyridine Metabolite

Article

Author: Niosi, Mark ; Walker, Gregory S ; Qiu, Ruolun ; Sharma, Raman ; Balesano, Amanda ; Wright, Stephen W ; Dantonio, Alyssa ; Dowty, Martin E ; Doran, Angela

Brepocitinib is an oral once-daily Janus kinase 1 and Tyrosine kinase 2 selective inhibitor currently in development for the treatment of several autoimmune disorders. Mass balance and metabolic profiles were determined using accelerator mass spectrometry in six healthy male participants following a single oral 60 mg dose of ¹⁴C-brepocitinib (∼300 nCi). The average mass balance recovery was 96.7% ± 6.3%, with the majority of dose (88.0% ± 8.0%) recovered in urine and 8.7% ± 2.1% of the dose recovered in feces. Absorption of brepocitinib was rapid, with maximal plasma concentrations of total radioactivity and brepocitinib achieved within 0.5 hours after dosing. Circulating radioactivity consisted primarily of brepocitinib (47.8%) and metabolite M1 (37.1%) derived from hydroxylation at the C5' position of the pyrazole ring. Fractional contributions to metabolism via cytochrome P450 enzymes were determined to be 0.77 for CYP3A4/5 and 0.14 for CYP1A2 based on phenotyping studies in human liver microsomes. However, additional clinical studies are required to understand the potential contribution of CYP1A1. Approximately 83% of the dose was eliminated as N-methylpyrazolyl oxidative metabolites, with 52.1% of the dose excreted as M1 alone. Notably, M1 was not observed as a circulating metabolite in earlier metabolic profiling of human plasma from a multiple ascending dose study with unlabeled brepocitinib. Mechanistic studies revealed that M1 was highly unstable in human plasma and phosphate buffer, undergoing chemical oxidation leading to loss of the 5-hydroxy-1-methylpyrazole moiety and formation of aminopyrimidine cleavage product M2. Time-dependent inhibition and trapping studies with M1 yielded insights into the mechanism of this unusual and unexpected instability. SIGNIFICANCE STATEMENT: This study provides a detailed understanding of the disposition and metabolism of brepocitinib, a JAK1/TYK2 inhibitor for atopic dermatitis, in humans as well as characterization of clearance pathways and pharmacokinetics of brepocitinib and its metabolites.

News (Medical) associated with Brepocitinib

12 Nov 2024

·www.globenewswire.com

Roivant Reports Financial Results for the Second Quarter Ended September 30, 2024, and Provides Business Update

BASEL, Switzerland and LONDON and NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the second quarter ended September 30, 2024, and provided a business update. Brepocitinib 52-week data from the Phase 2 NEPTUNE study in non-infectious uveitis (NIU) showed potential best-in-indication efficacy sustained to one year; first patients enrolled in Phase 3 NIU program IMVT-1402 cleared five Investigational New Drug (IND) applications across a range of therapeutic areas and FDA divisions, including the potentially registrational trial for difficult-to-treat rheumatoid arthritis (D2T RA) expected to initiate by March 31, 2025Batoclimab proof of concept data in Graves’ disease (GD) demonstrate potential of deeper IgG reduction with potent FcRn inhibition to transform treatment for GD patients who are not well controlled on antithyroid drugs (ATDs); initiation of potentially registrational trial to evaluate IMVT-1402 in GD expected by year endMosliciguat, a once-daily inhaled soluble guanylate cyclase (sGC) activator, unveiled as new pipeline program. Mosliciguat Phase 1b data in pulmonary hypertension (PH) patients demonstrated some of the highest pulmonary vascular resistance (PVR) reductions (~38%) in PH trials to date. The global Phase 2 PHocus trial for mosliciguat has been initiated in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD)Roivant continued to return capital through share repurchases with $106M purchased for the quarter, resulting in $754M cumulative share repurchases (inclusive of Sumitomo) through September 30, 2024Dermavant transaction with Organon closed on October 28, 2024. At closing, Roivant received $184M in cash, and Organon took on all of Dermavant’s remaining outstanding long-term debt, which, inclusive of Dermavant’s senior credit facility repaid at closing, had a carrying value of $336M as of September 30, 2024. In addition, Organon will pay Roivant a $75M milestone upon FDA approval for VTAMA in atopic dermatitis, with a target action date in Q1 2025Roivant reported consolidated cash, cash equivalents and marketable securities of approximately $5.4B at September 30, 2024 “I am pleased to finish out another quarter with continued clinical execution, including positive data in Graves’ Disease and FDA’s clearance of INDs in 5 indications at Immunovant,” said Matt Gline, CEO of Roivant. “I am also excited today to present the 52-week data from our Phase 2 study of brepocitinib in NIU. The sustained treatment benefits observed further our belief that brepocitinib is a potentially compelling and durable agent for a disease that is poorly treated today. We have a busy year ahead with major data expected in 2025 from Immunovant and Priovant, along with continued execution across other programs.” Recent Developments Immunovant: Endocrinology ProgramIn September 2024, Immunovant reported additional positive results from the Phase 2a trial of batoclimab in Graves’ Disease. Participants in the trial received 12 weeks of high dose batoclimab, 680 mg weekly by subcutaneous injection (SC) followed by 12 weeks of lower dose batoclimab, 340 mg weekly SC. At the end of the first 12 weeks, participants experienced a mean IgG reduction of 77% leading to a 76% Response rate. In addition, by the end of 12 weeks of higher dose batoclimab, 56% achieved an ATD-Free Response. During Weeks 13 to 24, the lower 340mg dose of batoclimab resulted in mean IgG reduction of 65% (vs. 77% on 680mg dose) with a correspondingly lower responder rate of 68%. In addition, a lower ATD-Free Response rate of 36% was also observed in the second 12 weeks. Patients who achieved at least a 70% IgG reduction at the end of the trial had nearly a threefold higher ATD-Free Response rate than those who did not (60% vs. 23%). Batoclimab was well tolerated with no new safety signals identified.In November 2024, additional data on the efficacy and safety of batoclimab in Graves’ thyroidal and extrathyroidal disease were presented in an oral presentation at the American Thyroid Association (ATA) 2024 Annual Meeting. These data showed that a 60% response rate (defined as T3 and T4 falling below the upper limit of normal (ULN) without increasing the ATD dose) was achieved by Week 2, demonstrating the rapidity of response to batoclimab 680mg dosed weekly. Meaningful improvements in proptosis and lid aperture were also observed at both Week 12 and Week 24. Pronounced improvements in multiple Thyroid-Related Patient-Reported Outcomes (ThyPRO-39) measurement scales were also observed, with ATD-Free Responders (defined as T3 and T4 falling below the ULN and ceasing all ATD medications) reporting greater improvements than other participants.Neurology ProgramIn November 2024, Immunovant announced completion of enrollment for patients included in Period 1 of the Phase 2b trial of batoclimab in CIDP, with data expected by March 31, 2025, to inform the trial design for a potentially registrational program with IMVT-1402.Rheumatology ProgramIn November 2024, Immunovant also announced FDA clearance of the IND for IMVT-1402 in D2T RA and expects to initiate a potentially registrational trial by March 31, 2025. Priovant: In September 2024, Priovant announced receipt of Fast Track designation from FDA for brepocitinib in NIU and enrolled the first patients in the Phase 3 program. New 52-week data from the Phase 2 NEPTUNE study of brepocitinib in NIU showed potential best-in-indication efficacy sustained to one year. Treatment failure rate in the 45 mg dose arm was 35% at week 52 vs. 29% at week 24. Treatment failure rate in the 15 mg dose arm was 56% vs. 44% at week 24. In each treatment arm only one additional patient failed from week 24 to 52. Other important efficacy measurements at week 52 were consistent with the week 24 data, including measurements of retinal vascular leakage and prevention and treatment of macular edema. Safety and tolerability were consistent with prior clinical studies of brepocitinib, with no new safety or tolerability signals identified. Brepocitinib has been dosed in over 1,400 subjects and patients with a safety profile that appears consistent with approved and widely prescribed JAK inhibitors. Pulmovant: In September 2024, Roivant unveiled mosliciguat, a potential first-in-class and best-in-category inhaled once-daily sGC activator. Mosliciguat is being developed for PH-ILD, which affects ~200,000 patients in the U.S. and Europe with limited or no treatment options. In September 2024, Pulmovant also presented data from the Phase 1b ATMOS study showing a single dose of inhaled mosliciguat in PH patients (N=38) led to sustained, clinically meaningful mean-max reductions in PVR of up to ~38%, one of the highest reductions seen in PH trials to date. Mosliciguat was generally well-tolerated, with low rates of treatment-emergent adverse events (TEAEs).Pulmovant initiated the global Phase 2 PHocus trial of mosliciguat in patients with PH-ILD. Roivant: In October 2024, Roivant reported the close of Organon’s acquisition of Dermavant. At closing, Roivant received $184M in cash and Organon took on all of Dermavant’s remaining outstanding long-term debt, which, inclusive of Dermavant’s senior credit facility repaid at closing, had a carrying value of $336M as of September 30, 2024. In addition, Organon will pay Roivant a $75M milestone upon FDA approval for VTAMA in atopic dermatitis, with a target action date in the first quarter of calendar year 2025. The transaction also includes payments of up to $950 million for the achievements of certain commercial milestones, in addition to the tiered royalties on net sales that Organon will pay Dermavant shareholders.Roivant continued to return capital through share repurchases with $106M purchased for the quarter ending September 30, 2024, resulting in $754M cumulative share repurchases (inclusive of the repurchase of Sumitomo’s stake in April 2024) through September 30, 2024.Roivant reported consolidated cash, cash equivalents and marketable securities of approximately $5.4B at September 30, 2024. Major Upcoming Milestones Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the fourth quarter of calendar year 2024. Immunovant plans to have initiated 4-5 potentially registrational programs by March 31, 2025, and plans to have initiated studies in a total of 10 indications by March 31, 2026, for IMVT-1402. In pursuit of this goal, Immunovant now has active INDs in Graves’ Disease and difficult-to-treat rheumatoid arthritis and expects to initiate potentially registrational trials in these indications by December 31, 2024 and March 31, 2025 respectively. Topline data from the batoclimab trial in MG is expected by March 31, 2025. Results from this trial are expected to inform a decision regarding next steps for batoclimab in MG and the design of the MG program for IMVT-1402, which is expected to initiate by March 31, 2025. Data from the batoclimab trial in CIDP is expected by March 31, 2025 and will be used to inform the trial design for a potentially registrational program for IMVT-1402. Topline data from the current pivotal program evaluating batoclimab in thyroid eye disease (TED) now expected in the second half of calendar year 2025. Priovant plans to report topline data from the ongoing Phase 3 trial of brepocitinib in DM in the second half of calendar year 2025.Genevant Markman hearing in Pfizer / BioNTech action scheduled for December 2024. Summary judgment phase of Moderna action scheduled for second and third quarter of calendar year 2025; Moderna trial scheduled for September 2025. Second Quarter Ended September 30, 2024 Financial Summary Cash and Marketable Securities As of September 30, 2024, the Company had consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $5.4 billion. Research and Development Expenses Research and development (R&D) expenses increased by $28.3 million to $143.1 million for the three months ended September 30, 2024, compared to $114.8 million for the three months ended September 30, 2023. This increase was primarily driven by increases in program-specific costs of $19.2 million, personnel-related expenses of $7.2 million, and share-based compensation of $1.6 million. Within program-specific costs, the increase of $19.2 million was primarily driven by an increase in expense of $34.2 million related to the anti-FcRn franchise, partially offset by a decrease in expense of $18.6 million related to RVT-3101, which was sold to Roche in December 2023. Non-GAAP R&D expenses were $132.4 million for the three months ended September 30, 2024, compared to $105.3 million for the three months ended September 30, 2023. General and Administrative Expenses General and administrative (G&A) expenses increased by $114.3 million to $202.9 million for the three months ended September 30, 2024, compared to $88.6 million for the three months ended September 30, 2023. This increase was primarily due to an increase in personnel-related expenses of $87.0 million, of which $79.1 million related to the one-time cash retention awards approved in July 2024 for each of Matthew Gline, Chief Executive Officer; Mayukh Sukhatme, President and Chief Investment Officer; and Eric Venker, President and Chief Operating Officer (the "2024 Senior Executive Compensation Program") and $6.6 million related to the special one-time cash retention bonus award granted to employees, following approval in December 2023. The increase was also driven by an increase in share-based compensation expense of $21.7 million, primarily due to the long-term equity incentive awards granted in July 2024 pursuant to the 2024 Senior Executive Compensation Program. Non-GAAP G&A expenses were $142.3 million for the three months ended September 30, 2024, compared to $49.6 million for the three months ended September 30, 2023. Loss from continuing operations, net of tax Loss from continuing operations, net of tax was $236.8 million for the three months ended September 30, 2024, compared to a loss from continuing operations, net of tax of $244.6 million for the three months ended September 30, 2023. On a basic and diluted per common share basis, loss from continuing operation was $0.25 and $0.28, respectively, for the three months ended September 30, 2024 and September 30, 2023. Non-GAAP loss from continuing operations, net of tax was $218.7 million for the three months ended September 30, 2024, compared to $154.8 million for the three months ended September 30, 2023. ROIVANT SCIENCES LTD.Selected Balance Sheet Data(unaudited, in thousands) September 30, 2024 March 31, 2024 Cash, cash equivalents and restricted cash$1,969,914 $6,506,189 Marketable securities 3,428,021 — Total assets 6,206,028 7,222,482 Total liabilities 625,986 773,953 Total shareholders’ equity 5,580,042 6,448,529 Total liabilities and shareholders’ equity 6,206,028 7,222,482 ROIVANT SCIENCES LTD.Condensed Consolidated Statements of Operations(unaudited, in thousands, except share and per share amounts) Three Months Ended September 30, Six Months Ended September 30, 2024 2023 2024 2023 Revenue, net$4,475 $3,648 $12,465 $8,131 Operating expenses: Cost of revenues 234 223 447 1,206 Research and development (includes $9,911 and $8,309 of share-based compensation expense for the three months ended September 30, 2024 and 2023 and $20,443 and $15,726 for the six months ended September 30, 2024 and 2023, respectively) 143,073 114,790 263,580 224,206 Acquired in-process research and development — 13,950 — 26,450 General and administrative (includes $59,443 and $37,755 of share-based compensation expense for the three months ended September 30, 2024 and 2023 and $96,284 and $76,472 for the six months ended September 30, 2024 and 2023, respectively) 202,881 88,576 302,773 179,858 Total operating expenses 346,188 217,539 566,800 431,720 Gain on sale of Telavant net assets — — 110,387 — Loss from operations (341,713) (213,891) (443,948) (423,589)Change in fair value of investments (48,375) 45,849 (63,601) 53,413 Change in fair value of liability instruments (635) 11,789 515 51,967 Gain on deconsolidation of subsidiaries — (17,354) — (17,354)Interest income (69,773) (14,299) (141,900) (31,014)Other expense, net 1,453 1,530 5,061 4,357 Loss from continuing operations before income taxes (224,383) (241,406) (244,023) (484,958)Income tax expense 12,458 3,236 24,421 4,911 Loss from continuing operations, net of tax (236,841) (244,642) (268,444) (489,869)(Loss) income from discontinued operations, net of tax (43,083) (86,476) 46,010 (169,094)Net loss (279,924) (331,118) (222,434) (658,963)Net loss attributable to noncontrolling interests (49,740) (26,791) (87,547) (62,820)Net loss attributable to Roivant Sciences Ltd.$(230,184) $(304,327) $(134,887) $(596,143)Amounts attributable to Roivant Sciences Ltd.: Loss from continuing operations, net of tax$(187,101) $(218,226) $(181,052) $(427,784)(Loss) income from discontinued operations, net of tax (43,083) (86,101) 46,165 (168,359)Net loss attributable to Roivant Sciences Ltd.$(230,184) $(304,327) $(134,887) $(596,143) Basic and diluted net (loss) income per common share:Basic and diluted loss from continuing operations$(0.25) $(0.28) $(0.25) $(0.56)Basic and diluted (loss) income from discontinued operations$(0.06) $(0.11) $0.06 $(0.22)Basic and diluted net loss per common share$(0.31) $(0.40) $(0.18) $(0.78) Weighted average shares outstanding: Basic 735,470,796 770,227,849 735,642,721 764,780,630 Diluted 735,470,796 770,227,849 735,642,721 764,780,630 ROIVANT SCIENCES LTD.Reconciliation of GAAP to Non-GAAP Financial Measures(unaudited, in thousands) Three Months Ended September 30, Six Months Ended September 30, Note 2024 2023 2024 2023 Loss from continuing operations, net of tax $(236,841) $(244,642) $(268,444) $(489,869)Adjustments: Research and development: Share-based compensation(1) 9,911 8,309 20,443 15,726 Depreciation and amortization(2) 724 1,205 1,419 2,694 General and administrative: Share-based compensation(1) 59,443 37,755 96,284 76,472 Depreciation and amortization(2) 1,094 1,235 2,184 2,485 Gain on sale of Telavant net assets(3) — — (110,387) — Other: Change in fair value of investments(4) (48,375) 45,849 (63,601) 53,413 Change in fair value of liability instruments(5) (635) 11,789 515 51,967 Gain on deconsolidation of subsidiaries(6) — (17,354) — (17,354)Estimated income tax impact from adjustments(7) (3,986) 1,100 (4,190) 369 Adjusted loss from continuing operations, net of tax (Non-GAAP) $(218,665) $(154,754) $(325,777) $(304,097) Three Months Ended September 30, Six Months Ended September 30, Note 2024 2023 2024 2023 Research and development expenses $143,073 $114,790 $263,580 $224,206 Adjustments: Share-based compensation(1) 9,911 8,309 20,443 15,726 Depreciation and amortization(2) 724 1,205 1,419 2,694 Adjusted research and development expenses (Non-GAAP) $132,438 $105,276 $241,718 $205,786 Three Months Ended September 30, Six Months Ended September 30, Note 2024 2023 2024 2023 General and administrative expenses $202,881 $88,576 $302,773 $179,858 Adjustments: Share-based compensation(1) 59,443 37,755 96,284 76,472 Depreciation and amortization(2) 1,094 1,235 2,184 2,485 Adjusted general and administrative expenses (Non-GAAP) $142,344 $49,586 $204,305 $100,901 Notes to non-GAAP financial measures:(1) Represents non-cash share-based compensation expense.(2) Represents non-cash depreciation and amortization expense.(3) Represents a gain on the sale of Telavant net assets to Roche due to achievement of a one-time milestone in June 2024.(4) Represents the unrealized (gain) loss on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings.(5) Represents the change in fair value of liability instruments, which is non-cash and primarily includes the unrealized (gain) loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.(6) Represents the one-time gain on deconsolidation of subsidiaries.(7) Represents the estimated tax effect of the adjustments. Investor Conference Call Information Roivant will host a live conference call and webcast at 8:00 a.m. ET on Tuesday, November 12, 2024, to report its financial results for the second quarter ended September 30, 2024, and provide a corporate update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call. About Roivant Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis and non-infectious uveitis; mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease; and namilumab, an anti-GM-CSF monoclonal antibody in development for the treatment of pulmonary sarcoidosis. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, www.roivant.com. Roivant Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts:InvestorsKeyur Parekh keyur.parekh@roivant.com MediaStephanie Leestephanie.lee@roivant.com

Phase 2Clinical ResultPhase 1Phase 3Drug Approval

28 Oct 2024

·www.globenewswire.com

Organon Completes Acquisition of Dermavant, including Innovative Dermatologic Therapy, VTAMA® (tapinarof) Cream, 1%

The acquisition expands Organon’s dermatology capabilities with a nonbiologic, non-steroidal topical treatment in the U.S.BASEL, Switzerland and LONDON and NEW YORK, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced the successful completion of its acquisition of Dermavant Sciences Ltd. from Roivant (NASDAQ: ROIV). Dermavant is a company dedicated to developing and commercializing innovative therapeutic solutions in immuno-dermatology. Please see our prior announcement for a summary of the transaction terms. VTAMA® (tapinarof) cream, 1%, is a novel nonbiologic, non-steroidal topical therapy approved by the U.S. Food and Drug Administration (FDA) for treatment of mild, moderate, and severe plaque psoriasis in adults with no safety label warnings or precautions and without restrictions on location and duration of use or body surface area. The FDA is reviewing a supplemental New Drug Application (sNDA) for VTAMA cream as a potential treatment for atopic dermatitis (AD) in adults and children two years of age and older, with Prescription Drug User Fee Act (PDUFA) action expected in the fourth quarter of calendar year 2024. Plaque psoriasis and atopic dermatitis-commonly known as eczema-are common chronic inflammatory skin diseases affecting millions of people in the U.S. and around the globe.1,2 Psoriasis presents a significant impact to quality of life and atopic dermatitis is associated with a higher disease burden for women compared to men.3,4“The future of dermatology depends on innovative treatments like VTAMA, and Organon’s acquisition of Dermavant allows us to further expand our existing portfolio of established brands and biosimilar dermatology treatments,” said Kevin Ali, Chief Executive Officer of Organon. “Integrating the expertise of Dermavant into Organon’s U.S. organization marks the beginning of a new chapter in dermatology. We are excited to bring this nonbiologic non-steroidal topical option to the millions of patients suffering from a chronic skin condition like plaque psoriasis and, potentially in the future, atopic dermatitis.” “I would like to thank Kevin and the entire Organon team for their partnership in the acquisition of Dermavant,” said Mayukh Sukhatme, MD, President and Chief Investment Officer of Roivant. “This deal represents a true win-win outcome for Organon and Roivant in our mutual goal to address patient needs and is emblematic of Roivant’s ability to form non-traditional, value-enhancing collaborations on important medicines. We believe that Organon’s strong global commercial footprint will maximize the impact of VTAMA for patients globally, and we are excited to continue to share meaningfully in the success of VTAMA along the way.” About VTAMA® (tapinarof) cream, 1%VTAMA cream is a non-steroidal once-daily topical treatment. The safety and effectiveness of VTAMA cream was evaluated in randomized, double-blind, vehicle-controlled trials, PSOARING-1 and 2 for plaque psoriasis. The safety and efficacy of VTAMA for the treatment of atopic dermatitis was also evaluated in ADORING-1 and ADORING-2 Phase III clinical studies and is currently under review with the FDA. Important Safety Information Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. VTAMA cream is for use on the skin (topical) only. Do not use VTAMA cream in your eyes, mouth, or vagina. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. See full Prescribing Information and Patient Information. About Organon Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers more than 60 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international markets. Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook. Cautionary Note Regarding Forward-Looking StatementsExcept for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management’s expectations about Organon’s acquisition of Dermavant (including statements regarding the timing, benefits, and financial impact of such acquisition), potential regulatory approvals and other actions relating to VTAMA (including the expected timeframe thereof), and Organon’s expected financial results and condition. Forward-looking statements may be identified by words such as “pursuing,” “foresees,” “future,” “potential,” “potentially,” “expected,” “expects,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward- looking statements. Risks and uncertainties include, but are not limited to, an inability to execute on our business development strategy or realize the benefits of our acquisition of Dermavant or any other planned acquisitions; weakening of economic conditions that could adversely affect the level of demand for Dermavant’s products; the risk that the business will not be integrated successfully; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the ability to retain key personnel; unknown liabilities; the risk of litigation and/or regulatory actions related to the completed acquisition; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; an inability to fully execute on Organon’s product development and commercialization plans in the United States, Europe, and elsewhere internationally; an inability to adapt to the industry-wide trend toward highly discounted channels; changes in tax laws or other tax guidance which could adversely affect Organon’s cash tax liability, effective tax rates, and results of operations and lead to greater audit scrutiny; expanded brand and class competition in the markets in which Organon operates; and governmental initiatives that adversely impact Organon’s marketing activities. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site www.sec.gov. References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites About Roivant Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis and non-infectious uveitis; and mosliciguat, an inhaled soluble sGC activator in development for pulmonary hypertension associated with interstitial lung disease, in addition to other clinical stage molecules. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, www.roivant.com. Roivant Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors, including (i) the possibility that the transaction may involve unexpected costs or liabilities, (ii) the risk that disruptions from the transaction will harm relationships with employees, customers and suppliers and other business partners or (iii) the risk that the achievement of the specified milestones or royalties described in the definitive agreement for the transaction may take longer to achieve than expected or may never be achieved and the resulting contingent milestone payments or royalties may never be realized. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts: InvestorsKeyur Parekh keyur.parekh@roivant.com MediaStephanie Leestephanie.lee@roivant.com 1 Armstrong, A., Mehta, M., Schupp, C., Gondo, C., Bell, S., Griffiths, C. Psoriasis Prevalence in Adults in the United States. JAMA Dermatol. 2021 Aug; 157(8):1-7. doi:10.1001/jamadermatol.2021.2007 2 Eczema Prevalence. National Eczema Foundation. Eczema Prevalence, Quality of Life and Economic Impact.3 Carole, G., Corsin, S., Meienberger, N., Valeska Maul, L., Maul, J-T. The Impact of Gender and Sex in Psoriasis: What to be Aware of When Treating Women with Psoriasis. Int J Women’s Dermatol. 2022 Jun; 8(2): e010. doi: 10.1097/JW9.0000000000000010. https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/pmc/articles/PMC9112394/ 4 Urban, K., Chu, S., Giesey, RL., Mehrmal, S., Uppal, P., Nedley, N., Delost, GR. The Global, Regional, and National Burden of Atopic Dermatitis in 195 Countries and Territories: An ecological study from the Global Burden of Disease Study 2017. 2021 Mar; 2: 12-18. JAAD International. doi: https://doi-org.libproxy1.nus.edu.sg/10.1016%2Fj.jdin.2020.10.002. https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/pmc/articles/PMC8362298/

Phase 3AcquisitionDrug ApprovalClinical Result

23 Sep 2024

·www.prnewswire.com

Priovant Therapeutics Announces Receipt of Fast Track Designation from FDA for Brepocitinib in Non-Anterior Non-Infectious Uveitis (NIU) & Start of Enrollment of Brepocitinib Phase 3 NIU Program

First patients have been dosed in CLARITY, a Phase 3 study evaluating brepocitinib in non-anterior non-infectious uveitis (NIU). Brepocitinib has also been granted Fast Track Designation from FDA for NIU. Study initiation follows successful Phase 2 study of brepocitinib in NIU (NEPTUNE) and productive End of Phase 2 Meeting with FDA. NEPTUNE 24-week wide field fluorescein angiography results were presented for first time at the EURETINA conference in Barcelona on September 20; clinically meaningful and dose-dependent improvement on retinal vascular leakage was observed from baseline to week 24, consistent with primary and secondary efficacy endpoints previously shared in the top-line readout. DURHAM, N.C., Sept. 23, 2024 /PRNewswire/ -- Priovant Therapeutics today announced that the first patients have been enrolled in CLARITY, a Phase 3 study evaluating brepocitinib in non-anterior non-infectious uveitis. Brepocitinib has also been granted Fast Track Designation for NIU by FDA. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Brepocitinib is a potential first-in-class dual selective inhibitor of TYK2 and JAK1 under evaluation for multiple highly morbid orphan autoimmune diseases. Brepocitinib is administered as an oral therapy dosed once daily. In a prior Phase 2 study evaluating brepocitinib in non-anterior NIU (NEPTUNE), a dose-dependent treatment benefit was observed on multiple endpoints of clinical significance. On the primary efficacy endpoint of Treatment Failure at six months, brepocitinib 45 mg showed the numerically greatest efficacy benefit observed to date of any therapy evaluated for NIU. Patient-level wide field fluorescein angiography (FA) results on retinal vascular leakage at six months were presented for the first time on September 20 at the EURETINA Congress in Barcelona, Spain. As measured through the Angiography Scoring for Uveitis Working Group (ASUWOG) grading system on wide field FA, brepocitinib 45 mg demonstrated a mean 4.4-point decrease in retinal vascular leakage while the 15 mg arm demonstrated a mean 0.5-point decrease. "FA is the gold standard measurement of posterior segment inflammation in uveitis," said Dilraj Grewal, MD, FASRS, Associate Professor of Ophthalmology, Vitreoretinal Surgery and Uveitis at Duke University and Associate Director of the Duke Reading Center, a comprehensive image reading center that specializes in systematic analysis of ophthalmic images captured in multicenter clinical trials. "The patient-level wide field FA results from the NEPTUNE trial show a clinically meaningful dose-dependent improvement on posterior segment inflammation from treatment with brepocitinib. With these results, the very strong clinical outcomes previously shared are now further supported by dose-dependent improvement on an important biomarker." CLARITY is a global multi-center Phase 3 program comparing brepocitinib 45 mg to placebo in patients with non-anterior NIU. CLARITY will consist of two sub-studies under a single protocol with 150 subjects in each sub-study (300 subjects total) randomized 1:1 to brepocitinib 45 mg and placebo, with a primary endpoint of Time to Treatment Failure. The study is closely modeled on the successful NEPTUNE Phase 2 study and will enroll subjects at sites in the United States, Europe, Asia, Australia, and South America. The initiation of CLARITY follows a productive End of Phase 2 Meeting with FDA. "The initiation of the CLARITY Study is an important milestone for the uveitis medical and patient communities," said Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, CLARITY investigator and Professor of Ophthalmology at the Byers Eye Institute, and Professor of Medicine and Pediatrics at Stanford University School of Medicine. "Non-infectious uveitis is a devastating disease that, if inadequately managed, often leads to irreversible visual impairment or blindness. Current treatment options fail to meet many patients' needs, and brepocitinib's striking Phase 2 results from the NEPTUNE Study suggest that it has the potential to serve as a transformative therapy in controlling inflammation and improving visual acuity." Patient-level macular edema results at week 24 from the NEPTUNE Study will be presented at the American Academy of Ophthalmology (AAO) annual meeting October 18-21 in Chicago. Top-line 52-week Phase 2 data from NEPTUNE will also be available by the end of the year. In addition to NIU, brepocitinib is being evaluated in a fully enrolled Phase 3 study in dermatomyositis (VALOR). Top-line data from the VALOR Study is expected in the second half of 2025, with an NDA submission to follow if successful. About Priovant Priovant Therapeutics is a biotechnology company dedicated to developing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company's lead asset is brepocitinib, a dual selective inhibitor of TYK2 and JAK1. Through dual TYK2/JAK1 inhibition, brepocitinib is able to distinctively suppress key cytokines linked to autoimmunity—including type I IFN, type II IFN, IL-6, IL-12, and IL-23—with a single, targeted therapy. Brepocitinib is administered as a once-daily oral therapy. It has been dosed in over 1,400 subjects and has generated positive data in seven Phase 2 studies. Brepocitinib is currently being evaluated in Phase 3 programs for dermatomyositis and non-infectious uveitis. Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking, which are usually identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "would" and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our products and product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our products and product candidates. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contact: Daniel Herz-Roiphe Priovant Therapeutics [email protected] SOURCE Priovant Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Phase 2Fast Track

100 Deals associated with Brepocitinib

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KEGG	Wiki	ATC	Drug Bank
D11537	-	-	DB15003

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-infectious posterior uveitis	Phase 3	US	Priovant Therapeutics, Inc.	23 Sep 2024
Uveitis, Intermediate	Phase 3	US	Priovant Therapeutics, Inc.	11 Sep 2024
Dermatomyositis	Phase 3	US	Roivant Sciences Ltd.	-
Colitis, Ulcerative	Phase 1	RU	Pfizer Inc.	03 Feb 2017
Alopecia Areata	Phase 1	AU	Pfizer Inc.	15 Dec 2016
Alopecia Areata	Phase 1	CA	Pfizer Inc.	15 Dec 2016
Alopecia Areata	Phase 1	US	Pfizer Inc.	15 Dec 2016
Plaque psoriasis	Phase 1	US	Pfizer Inc.	01 Dec 2016
Plaque psoriasis	Discovery	CA	Pfizer Inc.	01 Dec 2016
Plaque psoriasis	Discovery	PL	Pfizer Inc.	01 Dec 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03395184 (CTgov)	Phase 2	Crohn Disease	244	Placebo (Induction Period: Placebo QD)	ceoeclaitg(kpuwwuaira) = twmogqmqpi mdpiijnkvw (rbdwnqjqsj, ztqcwsidas - snwtlqkeqz) View more	-	30 Oct 2024
				Ritlecitinib (Induction Period: Ritlecitinib 200 mg/50 mg QD)	ceoeclaitg(kpuwwuaira) = rhppwbqruf mdpiijnkvw (rbdwnqjqsj, gxwikgwqkg - mokiwzbnbu) View more
NCT05523765 (NEPTUNE, EURETINA2024)	Phase 2	Non-infectious anterior uveitis	26	Brepocitinib 45 mg	spicnkqxre(gmvgumolot) = baiwcfcpfi hzsgrdjevo (lwgftzlrmv, 10.3 - 56.0)	Positive	19 Sep 2024
				Brepocitinib 15 mg	spicnkqxre(gmvgumolot) = wtwgkempye hzsgrdjevo (lwgftzlrmv, 13.7 - 78.8)
NCT03845517 (CTgov)	Phase 2	Systemic Lupus Erythematosus	350	Placebo (Placebo)	unrlvyaaoy(jlwscofgba) = tjqoyhwghr gydbwxwlvm (vpksdsqmmi, ixlpzohdih - rzomksivej) View more	-	05 Sep 2024
				PF-06700841 15 mg (PF-06700841 15 mg)	unrlvyaaoy(jlwscofgba) = crsxcdnznr gydbwxwlvm (vpksdsqmmi, iczklnbgzb - vfyjwesflm) View more
NCT05523765 (NEPTUNE, Biospace) Manual	Phase 2	Uveitis	26	brepocitinib 45 mg	(glcjuypgew) = eoejjzfklp xabyyzgiou (faxdpxkqab ) Met View more	Positive	02 Apr 2024
NCT04092452 (Pubmed \| NEJM Evid) Manual	Phase 2	Hidradenitis Suppurativa \|	194	zimlovisertib 400 mg	(gtjcgdhvso) = hthlmyrnbw iiuravtvmc (mlybmqngjq ) View more	Positive	27 Feb 2024
NCT04260464 (CTgov)	Phase 1	Renal Insufficiency	30	PF-06700841 (Severe Renal Impairment)	jdmgxcdjdj(abyjihtjhh) = lxbfmaikiq wzufazolfa (dxiixosuzj, gqbkvlqsrf - jrrdiyxohi) View more	-	22 Jan 2024
				PF-06700841 (Normal Renal Function)	jdmgxcdjdj(abyjihtjhh) = mvclpqmfcg wzufazolfa (dxiixosuzj, furdzkteqk - cmxvdsivga) View more
GlobeNewswire Manual	Phase 2	Systemic Lupus Erythematosus	-	Brepocitinib	(gdylfjxmfy) = Oral brepocitinib failed to meet its primary endpoint of Systemic Lupus Erythematosus Responder Index (SRI-4) change of 4 at Week 52 dsgqbiuago (vduyhvaplg ) Not Met View more	Negative	27 Nov 2023
NCT04092452 (CTgov)	Phase 2	Hidradenitis Suppurativa	194	placebo+PF-06826647+PF-06700841+PF-06650833 (Placebo)	fvooxqwdlq(dingxwqcnc) = tcrrwlquxz vfpubhocfe (ifcbzcjuds, tunvkdlifm - lqugppkiiq) View more	-	15 Jun 2023
				PF-06650833 (PF-06650833 400mg QD)	fvooxqwdlq(dingxwqcnc) = cjuneuuxoa vfpubhocfe (ifcbzcjuds, zzchdkefif - mcapiddtgr) View more
Pubmed	Not Applicable	Arthritis, Psoriatic	218	Brepocitinib 30 mg QD	(pblpzawgci) = sorjahwpwg jwqdjlikux (vwvulcuioh )	Positive	17 May 2023
				Brepocitinib 60 mg QD	(pblpzawgci) = tqvpvnyvrj jwqdjlikux (vwvulcuioh )
NCT03770039 (Pubmed)	Phase 1	-	6	Brepocitinib	pamchlxwdb(chugsasvob) = Brepocitinib was absorbed rapidly following oral administration iuhcfmuyhv (ytxihpnski )	-	15 May 2023

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