A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

Start Date21 Apr 2022

Sponsor / Collaborator

AnaptysBio, Inc.

NCT05352893

/ CompletedPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

Start Date14 Apr 2022

Sponsor / Collaborator

AnaptysBio, Inc.

EUCTR2021-001448-90-DE

/ Not yet recruitingPhase 3

A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis - Long-Term Safety and Efficacy of Imsidolimab in Subjects with Generalized Pustular Psoriasis

Start Date08 Dec 2021

Sponsor / Collaborator

AnaptysBio, Inc.

100 Clinical Results associated with Imsidolimab

100 Translational Medicine associated with Imsidolimab

100 Patents (Medical) associated with Imsidolimab

Literatures (Medical) associated with Imsidolimab

01 May 2024·American Journal of Clinical Dermatology

Small-Molecule Inhibitors and Biologics for Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Network Meta-Analysis

Review

Author: Huang, Yu-Huei ; Wu, Po-Chien ; Chiu, Hsien-Yi ; Huang, I-Hsin

BACKGROUNDThe comparative efficacy of biologics and small-molecule inhibitors in treating palmoplantar psoriasis (PP) and palmoplantar pustulosis (PPP) remains uncertain.OBJECTIVEThe aim was to perform a systematic review and network meta-analysis (NMA) to compare the efficacy of biologics and small-molecule inhibitors for the treatment of PP and PPP.METHODSMEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched for eligible studies from inception to May 13, 2023. This NMA was conducted and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension Statement for Network Meta-Analyses guidelines. Frequentist random-effects models NMA was performed with the surface under the cumulative ranking curve calculated for ranking. Our primary outcome was the proportion of patients achieving a clear/minimal Palmoplantar Psoriasis/Pustulosis Physician Global Assessment score (PPPGA 0/1 or PPPPGA 0/1) response at 12-16 weeks. Secondary outcomes consisted of the percentage of overall improvement in palmoplantar score and of improvement ≥ 75%, at 12-16 weeks.RESULTSThe study comprised a total of 29 randomized controlled trials (RCTs), involving 4798 psoriasis patients with palmoplantar diseases. For PP, 16 RCTs with nine different treatments, including adalimumab, apremilast, bimekizumab, etanercept, guselkumab, infliximab, ixekizumab, secukinumab, and ustekinumab were included for the analysis. In the NMA of PP, secukinumab 300 mg ranked highest (odds ratio [OR] 33.50, 95% confidence interval [CI] 4.37-256.86) in achieving PPPGA 0/1, followed by guselkumab 100 mg (OR 18.68, 95% CI 10.07-34.65). In the case of PPP, seven RCTs with six treatments, including apremilast, etanercept, guselkumab, imsidolimab, spesolimab, and ustekinumab, were included for the analysis. In the NMA of PPP, although no treatment demonstrated a significant difference compared to placebo in achieving PPPPGA 0/1, guselkumab 100 mg showed the greatest statistically significant improvement in the palmoplantar score (weighted mean difference 31.73, 95% CI 19.89-43.57) as a secondary outcome.CONCLUSIONAmong all available biologics and small-molecule inhibitors, secukinumab 300 mg and guselkumab 100 mg had the most favorable efficacy in treating PP and PPP, respectively.

17 Jul 2023·British Journal of Dermatology

Imsidolimab, an anti-interleukin-36 receptor monoclonal antibody, for the treatment of generalized pustular psoriasis: results from the phase II GALLOP trial

Article

Author: Gudjonsson, Johann E ; Reich, Adam ; Griffiths, Christopher E M ; Placek, Waldemar ; Zhou, Jihao ; Kaszuba, Andrzej ; Warren, Richard B ; Randazzo, Bruce ; Lizzul, Paul

AbstractBackgroundGeneralized pustular psoriasis (GPP) is a systemic inflammatory disease that can be severe, debilitating and life threatening. Uncontrolled activation of interleukin (IL)-36 proinflammatory activity may underlie the pathogenesis of GPP. Currently, GPP-specific treatment options are limited.ObjectivesTo evaluate the efficacy and safety of the anti-IL-36 receptor antibody imsidolimab in patients with GPP.MethodsIn an open-label, single-arm, multiple-dose study, patients with GPP were treated with imsidolimab to assess clinical efficacy, tolerability and safety. Patients received an intravenous dose of imsidolimab 750 mg on day 1, followed by three subcutaneous doses of imsidolimab 100 mg administered on days 29, 57 and 85. The primary efficacy endpoint was the proportion of patients who achieved a clinical response at weeks 4 and 16 following treatment with imsidolimab, as measured by the Clinical Global Impression scale.ResultsEight patients were enrolled and six completed the study. Responses were observed as early as day 3, most rapidly for pustulation relative to other manifestations of GPP, with continued and consistent improvement across multiple efficacy assessments at day 8, day 29 and through day 113. Most treatment-emergent adverse events (TEAEs) were mild to moderate in severity. No patient discontinued the study owing to a nonserious TEAE. Two patients experienced serious adverse events (SAEs); no deaths were reported.ConclusionsImsidolimab demonstrated a rapid and sustained resolution of symptoms and pustular eruptions in patients with GPP. It was generally well tolerated, with an acceptable safety profile, and is advancing to phase III trials. These data support the targeting of IL-36 signalling with a specific antibody – imsidolimab – as a therapeutic option for this severely debilitating condition.

17 Jul 2023·The British journal of dermatology

Imsidolimab: an emerging biological therapy for generalized pustular psoriasis.

Communications

Author: Gleeson, David ; Mahil, Satveer K

News (Medical) associated with Imsidolimab

13 Feb 2025

·www.prnewswire.com

Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results

Q4 2024 total revenues of $53.2 million, +17% compared to Q4 2023 Q4 2024 Fanapt® net product sales of $26.6 million, +18% compared to Q4 2023 Full year 2024 total revenues of $198.8 million, +3% compared to full year 2023 Full year 2025 revenue expected to grow to $210 to $250 million Psychiatry portfolio revenue expected to grow to greater than $750 million in 2030 Fanapt® MAA for bipolar I disorder and schizophrenia submitted in Q4 2024 BysantiTM (milsaperidone) NDA for bipolar I disorder and schizophrenia expected to be submitted in Q1 2025 HETLIOZ® MAA for Smith-Magenis syndrome submitted in Q4 2024 Tradipitant NDA for motion sickness submitted in Q4 2024 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025 WASHINGTON, Feb. 13, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2024. "Strong revenue growth for Fanapt is putting us on a significant growth trajectory for 2025 and beyond, supported also by the commercial performance of Hetlioz and Ponvory. The Fanapt long acting injectable program, the NDA for Bysanti for bipolar disorder and schizophrenia along with its development for major depressive disorder have the potential to drive future growth in our psychiatry portfolio for many years to come," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "Tradipitant's NDA for motion sickness was filed with a potential approval this year, while we are pursuing approval in gastroparesis and the development of tradipitant to improve tolerability of GLP-1 analog Wegovy. Our anti-inflammatory portfolio, anchored by Ponvory, was strengthened with the addition of imsidolimab from Anaptys, an IL-36 receptor inhibitor for the treatment of generalized pustular psoriasis. We plan to file a BLA later this year while we are exploring registration in Europe and Japan as well as the development of this novel drug for other inflammatory disorders with an unopposed action of the IL-36 system. In 2024 we returned to revenue growth driven by the commercial launches in bipolar disorder and multiple sclerosis and advanced our development pipeline with a number of products at or near marketing applications. All this was achieved by the hard work, ingenuity and efficiency of our organization and its wonderful people." Financial Highlights Fourth Quarter of 2024 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $53.2 million in the fourth quarter of 2024, a 17% increase compared to $45.3 million in the fourth quarter of 2023 and a 12% increase compared to $47.7 million in the third quarter of 2024. Fanapt® net product sales were $26.6 million in the fourth quarter of 2024, an 18% increase compared to $22.6 million in the fourth quarter of 2023 and an 11% increase compared to $23.9 million in the third quarter of 2024. HETLIOZ® net product sales were $20.0 million in the fourth quarter of 2024, a 5% decrease compared to $21.1 million in the fourth quarter of 2023 and a 12% increase compared to $17.9 million in the third quarter of 2024. PONVORY® net product sales were $6.5 million in the fourth quarter of 2024, an increase of 11% compared to $5.9 million in the third quarter of 2024. The acquisition of PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company, was completed on December 7, 2023. Net loss was $4.9 million in the fourth quarter of 2024 compared to net loss of $2.4 million in the fourth quarter of 2023 and net loss of $5.3 million in the third quarter of 2024. Cash, cash equivalents and marketable securities (Cash) was $374.6 million as of December 31, 2024, representing a decrease to Cash of $1.6 million compared to September 30, 2024. Full Year 2024 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $198.8 million for the full year 2024, a 3% increase compared to $192.6 million for the full year 2023. Fanapt® net product sales were $94.3 million for the full year 2024, a 4% increase compared to $90.9 million for the full year 2023. HETLIOZ® net product sales were $76.7 million for the full year 2024, a 23% decrease compared to $100.2 million for the full year 2023. The decrease relative to the full year 2023 was the result of continued generic competition in the U.S. PONVORY® net product sales were $27.8 million for the full year 2024. The acquisition of PONVORY® from Janssen was completed on December 7, 2023. Net loss was $18.9 million for the full year 2024, compared to net income of $2.5 million for the full year 2023. Cash was $374.6 million as of December 31, 2024, representing a decrease to Cash of $13.6 million compared to December 31, 2023. Key Operational Highlights Fanapt® (iloperidone) Fanapt® was approved in the second quarter of 2024 for the acute treatment of bipolar I disorder. Vanda initiated the commercial launch of Fanapt® in this indication in the third quarter of 2024. In the fourth quarter of 2024, as compared to the fourth quarter of 2023, new patient starts, as reflected by new to brand prescriptions (NBRx),1 increased by over 160% and Fanapt® net product sales increased by 18%. Vanda initiated a Phase III program for the long acting injectable (LAI) formulation of Fanapt® in the fourth quarter of 2024. Vanda plans to initiate a study of the Fanapt® LAI as a once-a-month injectable for the treatment of hypertension to address both treatment resistance and treatment compliance. Vanda submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the fourth quarter of 2024 for Fanapt® for bipolar I disorder and schizophrenia. Bysanti™ (milsaperidone) Vanda expects to submit a New Drug Application (NDA) for Bysanti™ to the U.S. Food and Drug Administration (FDA) for the treatments of acute bipolar I disorder and schizophrenia in the first quarter of 2025. Exclusivity, including pending patent applications, could extend into the 2040s. Vanda initiated a Phase III clinical study for Bysanti™ as a once-daily adjunctive treatment for major depressive disorder (MDD) in the fourth quarter of 2024. Results are expected in 2026. HETLIOZ® (tasimelteon) Vanda has initiated clinical programs for HETLIOZ® in pediatric insomnia and delayed sleep phase disorder (DSPD) and these programs are ongoing. Vanda's MAA for HETLIOZ® and HETLIOZ LQ® for Smith-Magenis Syndrome (SMS) is pending with the EMA. PONVORY® (ponesimod) Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024. Investigational New Drug (IND) applications for PONVORY® in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024. Tradipitant The NDA for tradipitant for the treatment of motion sickness was submitted to the FDA in the fourth quarter of 2024. Vanda initiated a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy (semaglutide), in the fourth quarter of 2024. Vanda has accepted the opportunity for a hearing with the FDA on the approvability of the NDA for tradipitant for the treatment of symptoms of gastroparesis. Imsidolimab In February 2025, Vanda announced it entered into an exclusive, global license agreement with AnaptysBio, Inc. (Anaptys) for the development and commercialization of imsidolimab (IL-36R antagonist mAb). Vanda expects to initiate and complete the technology transfer activities in 2025 and immediately begin preparing the Biologics License Application (BLA) and MAA for generalized pustular psoriasis (GPP) for the US and EU. The imsidolimab BLA for GPP is expected to be submitted to the FDA in 2025. Early-Stage Program Highlights VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. Vanda expects to initiate a Phase III program in 2025. The IND application for VCA-894A in the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment, was accepted by the FDA in 2024. Previously in 2023, VCA-894A was granted Orphan Drug Designation for the same indication. The Phase I clinical study for VCA-894A expects to enroll the patient by mid-2025. In December 2024, Vanda announced that the FDA has granted Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor for the treatment of polycythemia vera (PV), a form of a rare hematologic malignancy that is estimated to affect 1 in 2,000 Americans. Key Regulatory Milestones Tradipitant NDA for motion sickness submitted in Q4 2024. Fanapt® MAA for bipolar I disorder and schizophrenia submitted in Q4 2024. HETLIOZ® MAA in Smith-Magenis syndrome (SMS) submitted in Q4 2024. Bysanti™ NDA for bipolar I disorder and schizophrenia expected to be submitted in Q1 2025. Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025. GAAP Financial Results Net loss was $4.9 million in the fourth quarter of 2024 compared to net loss of $2.4 million in the fourth quarter of 2023. Diluted net loss per share was $0.08 in the fourth quarter of 2024 compared to diluted net loss per share of $0.04 in the fourth quarter of 2023. Net loss was $18.9 million for the full year 2024 compared to net income of $2.5 million for the full year 2023. Diluted net loss per share was $0.33 for the full year 2024 compared to diluted net income per share of $0.04 for the full year 2023. 2025 Financial Guidance and 2030 Revenue Targets Vanda expects to achieve the following financial objectives in 2025: Vanda is providing 2030 revenue targets. For the psychiatry portfolio alone, Vanda is targeting annual revenue in excess of $750 million in 2030, assuming the potential approval of Bysanti™ for the treatments of acute bipolar I disorder and schizophrenia in early 2026, the potential approval of Bysanti™ for the treatment of MDD, and the potential approval of Fanapt® LAI. Vanda is also targeting total annual revenue in excess of $1 billion in 2030. Conference Call Vanda has scheduled a conference call for today, Thursday, February 13, 2025, at 4:30 PM ET. During the call, Vanda's management will discuss the fourth quarter and full year 2024 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 2881765. A replay of the call will be available on Thursday, February 13, 2025, beginning at 8:30 PM ET and will be accessible until Thursday, February 20, 2025 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 2881765. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2025 Financial Guidance and 2030 Revenue Targets" above and the related implied growth of Vanda's business, and statements regarding Vanda's plans for pursuit of FDA approval of BysantiTM for the treatments of acute bipolar I disorder and schizophrenia and imsidolimab for the treatment of GPP, and the related timelines; Vanda's expectations with respect to the growth opportunities for its psychiatry frachise; Vanda's consideration of foreign regulatory approval for imsidolimab and its potential development for other inflammatory disorders; Vanda's clinical development plans and expected timelines for Fanapt® LAI, BysantiTM for the treatment of MDD, VQW-765 for the treatment of acute performance anxiety in social situations, and VCA-894A for the treatment of CMT2S; the commercial and therapeutic potential for BysantiTM; the potential to extend patent exclusivity for BysantiTM into the 2040s; the anticipated timing of the initiation and completion of technology transfer activities and the preparation of regulatory filings in the US and EU for imsidolimab; and the prevalence of PV are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to continue to grow its psychiatry portfolio and overall business; the results of Vanda's review of foreign regulatory opportunities for imsidolmab; Vanda's ability to identify additional indications for imsidolimab; Vanda's ability to complete and submit to the FDA the NDA for BysantiTM for the treatments of acute bipolar I disorder and schizophrenia in the first quarter of 2025; Vanda's ability to complete and submit the BLA for imsidolimab for the treatment of GPP in 2025; Vanda's ability to complete the Phase III clinical study for BysantiTM for MDD and receive results in 2026; Vanda's ability to initiate the Phase III program for VQW-765 in 2025; Vanda's ability to enroll the CMT2S patient in the Phase I clinical study for VCA-894A by mid-2025; Vanda's ability to complete the clinical development of, obtain regulatory approval for, and successfully commercialize, BysantiTM for the treatments of acute bipolar I disorder, schizophrenia and MDD; Vanda's ability to satisfy the conditions necessary to extend BysantiTM's patent exclusivity into the 2040s; Vanda's ability to initiate and complete the technology transfer activities and prepare the BLA and MAA for imsidolimab in the specified timeframes; and the accuracy of the estimate regarding the prevalence of PV. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 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License out/inDrug ApprovalNDAPhase 1Phase 3

12 Feb 2025

·www.fiercebiotech.com

AnaptysBio\'s PD-1 drug reduces rheumatoid arthritis in phase 2 trial

TD Owen analysts had described the trial\'s readout as “hotly debated” in the wake of Eli Lilly halting its own PD-1 program in RA last year.\n AnaptysBio may have ended last year on a low, but 2025 is looking up with the news that its PD-1 agonist rosnilimab has hit the goals of a phase 2 rheumatoid arthritis (RA) trial.The phase 2b RENOIR study assessed three doses of subcutaneous rosnilimab—100 mg every four weeks, 400 mg every four weeks or 600 mg every two weeks—versus placebo in 424 patients with moderate-to-severe RA who were also receiving standard antirheumatic drugs such as methotrexate.All three doses hit the trial’s primary endpoint of demonstrating a statistically significant change from baseline in disease activity after 12 weeks, the company said in a Feb. 12 release. Specifically, the 100 mg and 600 mg dose cohorts saw a mean reduction of 2.06 in the DAS28-CRP score, while the 400 mg cohort saw a reduction of 2.12.In a 2025 lookahead last month, TD Owen analysts had described the trial\'s readout as “hotly debated” in the wake of Eli Lilly halting its own PD-1 program in RA last year.The secondary endpoints of Anaptys\' study assessed treatment response and disease activity at Week 12 and 14. On these measures at Week 12, rosnilimab achieved statistical significance “in at least one dose and numerical superiority at all doses … even though higher than typical placebo rates were observed,” the biotech said. The San Diego-based company pointed to the 69% of rosnilimab-treated patients who met the target of reduced disease activity at Week 14 as a sign of the drug’s potential.“We are excited about these trial results and the impact they could have on patients living with RA,” Anaptys CEO Daniel Faga said in the release. “Rosnilimab is safe and well tolerated with the highest ever reported CDAI low disease activity at ~3 months that, to date, is sustained and potentially deepening over six months.”“These findings, further supported by objective translational data, surpass our target product profile in the ~$20 billion U.S. RA market,” Faga added.The readout marks some welcome good news for Anaptys, which dropped an atopic dermatitis candidate in December after the compound failed to reduce eczema area and itch severity in a phase 2b trial.The company will be hoping the good luck continues for its phase 2 readout of rosnilimab in ulcerative colitis, which is penciled in for the fourth quarter.The biotech entered 2025 with about $415 million in the bank, which it expected to fund operations through the end of 2027, excluding potential milestone and royalty payments from its immuno-oncology partnership with GSK.Earlier this month, Vanda Pharmaceuticals agreed to pay $10 million upfront for the license to Anaptys’ phase 3-stage pustular psoriasis drug imsidolimab.

$AnaptysBio\'s PD-1 drug reduces rheumatoid arthritis in phase 2 trial$

Phase 2Clinical ResultLicense out/inPhase 3

04 Feb 2025

·www.pharmaceutical-technology.com

Vanda and AnaptysBio link for generalised pustular psoriasis therapy

The trials assessed the efficacy and safety of the therapy in patients with GPP, a severe skin disorder. Credit: Kmpzzz/Shutterstock. Vanda Pharmaceuticals and AnaptysBio have announced an exclusive worldwide licence agreement to develop and commercialise the fully humanised immunoglobulin G4 (IgG4) antibody, imsidolimab, to treat the severe skin disorder generalised pustular psoriasis (GPP). The agreement follows the completion of two Phase III trials, GEMINI-1 and GEMINI-2, which assessed the efficacy and safety of the therapy. Vanda will pay AnaptysBio $10m upfront along with a $5m payment for the current drug supply. Anaptys will receive future regulatory approval and sales milestones amounting to $35m, along with a 10% net sales royalty. With this deal, Vanda secures the rights to develop, manufacture and commercialise imsidolimab globally. Vanda Pharmaceuticals president, CEO and board chairman Mihael Polymeropoulos stated: “We are excited to add imsidolimab to Vanda’s product portfolio for rare orphan disorders, as well as explore the potential of this IL-36 signal regulator in the treatment of additional inflammatory conditions where the IL-36 homeostatic balance is dysregulated.” Guggenheim Securities and Fenwick & West served as financial advisor and legal counsel respectively to AnaptysBio during the transaction. Vanda was advised by Cantor Fitzgerald & Co. Orrick, Herrington & Sutcliffe provided legal counsel. By blocking IL-36R, Imsidolimab corrects the deficiency of the endogenous IL-36 regulator in GPP patients. With the development programme, including the GEMINI-1 and GEMINI-2 Phase III studies, now concluded, Vanda is preparing for technology transfer activities in 2025. The company will begin preparing the marketing authorisation application (MAA) and biologics licence application (BLA) for regulatory submission in the EU and the US. Regulatory and patent exclusivity for imsidolimab is anticipated to extend into the 2030s. In December 2023, the US Food and Drug Administration accepted a new drug application from Vanda for tradipitant, aimed at treating gastroparesis.

License out/inPhase 3Immunotherapy

100 Deals associated with Imsidolimab

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KEGG	Wiki	ATC	Drug Bank
D11892	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Generalized Pustular Psoriasis	Phase 3	Spain	AnaptysBio, Inc.	14 Apr 2022
Generalized Pustular Psoriasis	Phase 3	South Korea	AnaptysBio, Inc.	14 Apr 2022
Generalized Pustular Psoriasis	Phase 3	United States	AnaptysBio, Inc.	14 Apr 2022
Generalized Pustular Psoriasis	Phase 3	Taiwan Province	AnaptysBio, Inc.	14 Apr 2022
Generalized Pustular Psoriasis	Phase 3	Slovakia	AnaptysBio, Inc.	14 Apr 2022
Generalized Pustular Psoriasis	Phase 3	Turkey	AnaptysBio, Inc.	14 Apr 2022
Generalized Pustular Psoriasis	Phase 3	Germany	AnaptysBio, Inc.	14 Apr 2022
Generalized Pustular Psoriasis	Phase 3	Georgia	AnaptysBio, Inc.	14 Apr 2022
Generalized Pustular Psoriasis	Phase 3	Romania	AnaptysBio, Inc.	14 Apr 2022
Generalized Pustular Psoriasis	Phase 3	Poland	AnaptysBio, Inc.	14 Apr 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05366855 (GEMINI-2, GlobeNewswire) Manual	Phase 3	Generalized Pustular Psoriasis Maintenance	16	imsidolimab (GEMINI-2 + GPPPGA 0/1 responder patients from GEMINI-1)	(keulnrobhh) = mmcitiftvu oinbzwvyfh (vrmcttobpt )	Positive	09 May 2024
NCT05352893 (GEMINI1, GlobeNewswire) Manual	Phase 3	Generalized Pustular Psoriasis	45	Imsidolimab 750mg (GEMINI-1)	(xgrlrwbsam) = nqzysxvqus qskbfqjxrx (xoeumrdjke )	Positive	09 May 2024
				Imsidolimab 300mg (GEMINI-1)	(xgrlrwbsam) = dxsvyfbyip qskbfqjxrx (xoeumrdjke )
NCT05352893 (GEMINI1, Corporate Publications) Manual	Phase 3	Generalized Pustular Psoriasis	45	Imsidolimab	(hvmiiveobv) = fwglpfikpo afmvytruwh (duwdorpnkb ) Met View more	Positive	09 Oct 2023
				Placebo	(hvmiiveobv) = ilozbevrdg afmvytruwh (duwdorpnkb ) Met
NCT04856917 (CTgov)	Phase 2	Acne Vulgaris	123	Imsidolimab (Imsidolimab 400/200 mg)	fqymhrkojn(auzzxwhcha) = kaiztwcvqp vuckjymnfx (vkxodbpiky, yjcaipkjbf - nlekoekrbr) View more	-	15 Jun 2023
				Imsidolimab (Imsidolimab 200/100 mg)	fqymhrkojn(auzzxwhcha) = stpidmcmtw vuckjymnfx (vkxodbpiky, loucykwjqz - lnbczjnfkx) View more
NCT04697056 (CTgov)	Phase 2	Ichthyosis	5	Imsidolimab (Imsidolimab)	hrwwmhbflg(dzwktdfvrh) = ysswqdmekk mmepvjewwz (xazocktqcm, yqaintpnbw - vzxzpdghln) View more	-	02 Mar 2023
				placebo (Placebo)	hrwwmhbflg(dzwktdfvrh) = enzjkbhdfp mmepvjewwz (xazocktqcm, ajrescpulj - cibjcacwfq) View more
NCT04697069 (CTgov)	Phase 2	Neoplasms \| Acneiform Eruptions	4	Placebo	ohhammyrtd(ujxfaghppw) = fzhmarsmdw sfyuslzdws (ryffbazogr, hizhexftqa - hhltzywowl) View more	-	09 Jan 2023
NCT03633396 (POPLAR, CTgov)	Phase 2	Psoriasis	59	Placebo (Placebo)	iosxncqxfq(ladqcqjewd) = luvboupxey vusldnbgit (issbqmkcht, uczhadohrl - zewsblqjxd) View more	-	31 May 2022
				Imsidolimab (Imsidolimab)	iosxncqxfq(ladqcqjewd) = rkjdejqsfp vusldnbgit (issbqmkcht, wgsqkewkbp - fxqzxbpuid) View more
NCT03619902 (GALLOP \| GPP, CTgov)	Phase 2	Generalized Pustular Psoriasis	8	Imsidolimab	guzhmjcnxd(ykzbkwnmlw) = gkrlhkrokx sjdloiscka (dticrjlezn, fnrhmqpzmt - cgzydycjxw) View more	-	29 Mar 2022
NCT03633396 (POPLAR, GlobeNewswire) Manual	Phase 2	Psoriasis	-	Imsidolimab	(prdioliidd) = pbdpdzdcwy dlnzrnoxbq (gavtxaogzo ) View more	Negative	08 Mar 2021
				Placebo	(prdioliidd) = evoopbzlhq dlnzrnoxbq (gavtxaogzo ) View more
NCT03619902 (GALLOP, Biospace) Manual	Phase 2	Generalized Pustular Psoriasis	8	Imsidolimab	(yegaqihhhe) = lfcyofjwpu ywptcqskjr (uqsvfcupby ) View more	Positive	13 Oct 2020

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