A Randomized, Controlled, Open-label, Phase II Clinical Study Evaluating the JAK1 Inhibitor Ivarmacitinib to Reverse Immunotherapy Resistance in Triple-negative Breast Cancer

This is a prospective, open-label, randomized phase II clinical study which recruits unresectable recurrent or metastatic triple-negative breast cancer resistant to immunotherapy.

Start Date01 Dec 2024

Sponsor / Collaborator

Fudan University

NCT06519526 / RecruitingPhase 2IIT

Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma

This is an open-label, prospective and exploratory clinical study to evaluate the efficacy and safety of JAK inhibitor SHR-0302 in combination with EZH2 inhibitor SHR-2554 in patients with R/R PTCL. The study plans to enroll approximately 25 patients. 6-12 patients will receive SHR-0302 monotherapy and SHR-0302+SHR-2554 combination therapy in the safety run-in phase. According to the safety observed, the investigators discuss and decide to select a dose group to explore the efficacy and safety. 13 patients may be enrolled in the expansion phase.

Start Date12 Aug 2024

Sponsor / Collaborator

Fudan University

NCT06202612 / Active, not recruitingPhase 1

A Bioavailability Study of SHR0302 Tablet in Healthy Subjects

The purpose of this study is to evaluate and compare the pharmacokinetics of SHR0302 two different kind tablets in Healthy subjects after administration two kind tablets (quick release tablets and sustained-release tablets).

Start Date16 Jan 2024

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Ivarmacitinib

100 Translational Medicine associated with Ivarmacitinib

100 Patents (Medical) associated with Ivarmacitinib

Literatures (Medical) associated with Ivarmacitinib

27 Nov 2024·ANNALS OF THE RHEUMATIC DISEASES

Ivarmacitinib, a selective Janus kinase 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: results from a phase III randomised clinical trial.

Article

Author: Li, Yasong ; Jiang, Zhenyu ; He, Xiaohong ; Lin, Changsong ; Xie, Xi ; Zhan, Feng ; Duan, Xinwang ; Chen, Lin ; Sun, Yuqi ; Yang, Lei ; Jin, Hongtao ; Qian, Long ; Zeng, Xiaofeng ; Du, Zhengfu ; Zheng, Zhaohui ; Xu, Shengqian ; Gong, Huiping ; Liu, Jinjing ; Mi, Cundong ; Liu, Shengyun ; Dong, Guangchao ; Zhang, Shangzhu ; Su, Jingbo ; Wei, Hua ; Liu, Jing ; Wang, Jian ; Zhang, Ning ; Zhu, Jing ; Luo, Hui ; Xie, Qibing ; Shi, Xiaofei ; Wu, Rui ; Jiang, Ying ; Geng, Xiuqin ; Liu, Huaxiang

OBJECTIVE:

To assess the efficacy/safety of ivarmacitinib, a selective Janus kinase (JAK) 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis (RA) who had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).

METHODS:

Patients were randomised (1:1:1) to receive either placebo (n=188), ivarmacitinib 4 mg (n=189) or ivarmacitinib 8 mg (n=189) once daily, with background csDMARDs allowed. After 24 weeks, patients on placebo switched to ivarmacitinib 4 mg for an additional 28 weeks, while those on ivarmacitinib continued their initial dosage. The primary endpoint was the proportion of patients achieving a 20% improvement in the American College of Rheumatology response criteria (ACR20) at week 24.

RESULTS:

At week 24, ACR20 response rates were significantly higher in the ivarmacitinib 4 mg (70.4%) and 8 mg (75.1%) groups compared with the placebo group (40.4%; both p<0.0001). Both ivarmacitinib doses achieved numerically higher Disease Activity Score 28-joint count C reactive protein of <2.6/≤3.2 response rates compared with placebo. Improvements in efficacy and patient-reported outcomes were sustained through 52 weeks and were noted in patients who switched from placebo after week 24. During the placebo-controlled period, treatment-emergent adverse events (TEAEs) occurred in 81.5% and 90.5% of patients in the ivarmacitinib 4 mg and 8 mg groups, versus 79.3% in the placebo group. Infection-related TEAEs were slightly higher in the ivarmacitinib groups.

CONCLUSIONS:

Ivarmacitinib may offer a potential therapeutic option for patients with RA who have an inadequate response to csDMARDs, with a safety profile that was generally manageable over 1 year of treatment and similar to other JAK inhibitors.

TRIAL REGISTRATION NUMBER:

NCT04333771.

01 May 2024·Journal of the European Academy of Dermatology and Venereology : JEADV

Comparative efficacy of oral Janus kinase inhibitors and biologics in adult alopecia areata: A systematic review and Bayesian network meta‐analysis

Review

Author: Husein-ElAhmed, Sara ; Husein-ElAhmed, Husein

Abstract:

Alopecia areata (AA) is an autoimmune disorder that affects the hair follicles, resulting in patchy recurrent hair loss. A large body of evidence has demonstrated the favourable clinical response of the Janus kinase (JAK) inhibitors and biologics, but a lack of comprehensive comparison among these therapies exists in the current literature. This study aimed to compare their efficacy. A systematic review and meta‐analysis were performed including randomized trials that report the outcomes of the Severity of Alopecia Tool (SALT)50 and/or the mean change in SALT. These articles were pooled and a network meta‐analysis (NAM) was conducted. Based on the surface under the cumulative ranking curve estimates obtained for the mean change in SALT score, baricitinib_4 mg (0.7949656) had the best probability of being the most effective therapy, followed by ritlecitinib_200_50 mg (0.7391906) and ivarmacitinib_4 mg (0.7292594). In contrast, dupilumab, secukinumab, tralokinumab and apremilast were less likely to be effective. Targeting the JAK signalling pathway holds great potential for restoring hair regrowth, albeit the contribution of JAK1, JAK2, JAK3 and TYK2 inhibition to the therapeutic effect on AA is apparently different. Baricitinib_4 mg and ritlecitinib 200_50 mg demonstrated notable efficacy, and both molecules displayed a dose‐dependent effect, which is not observed with ivarmacitinib. Further investigations into the specific mechanisms of action of these JAK inhibitors are warranted to elucidate the reasons behind these differences.

01 Dec 2023·British journal of clinical pharmacology

Effect of SHR0302 on the pharmacokinetics of CYP3A4, CYP2C8, CYP2C9 and CYP2C19 probe substrates in healthy volunteers: A cocktail analysis

Article

Author: Luo, Lin ; Fu, Meng ; Gu, Fei ; Shen, Kai ; Lin, Hongda ; Huang, Jianying ; Fan, Yang ; Lu, Zekun ; Feng, Sheng ; Wu, Bing

Abstract:

Aims:

This study evaluated the effects of SHR0302 on the pharmacokinetics of cytochrome P450 (CYP) probe substrates.

Methods:

We performed a single‐centre, open‐label, three‐period drug–drug interaction (DDI) study in 24 healthy subjects (NCT05392127). Subjects received a single oral dose of 5 mg warfarin (CYP2C9), 20 mg omeprazole (CYP2C19) and 15 mg midazolam (CYP3A4) on Days 1, 8 and 22, and received 0.5 mg repaglinide (CYP2C8) on Days 7, 14 and 28. Multiple oral doses of 8 mg SHR0302 were administered once daily from Day 8 to Day 28.

Results:

The exposure of S‐warfarin and repaglinide were comparable before and after SHR0302 administration. AUC of midazolam was not affected by SHR0302, whereas the administration of SHR0302 slightly decreased the Cmax of midazolam by 7.6% (single dose) and 15.7% (once daily for 14 days). The AUC0‐t, AUC0‐inf, and Cmax of omeprazole were slightly decreased after a single dose of SHR0302 by 19.2%, 21.8% and 23.5%, respectively. In the presence of SHR0302 for 14 days, the AUC0‐t, AUC0‐inf, and Cmax of omeprazole were marginally reduced by 3.0%, 16.4% and 8.3%, respectively. According to the induction mechanism of the CYP enzyme, for the investigation of the induction effect, the results of multiple administrations of the perpetrator were more reliable than those of the single dose.

Conclusions:

The results demonstrated that co‐administration of SHR0302 8 mg once daily is unlikely to have a clinically meaningful effect on the exposure of drugs metabolized by CYP3A4, CYP2C8, CYP2C9 and CYP2C19 in healthy subjects.

News (Medical) associated with Ivarmacitinib

06 Nov 2024

·www.globenewswire.com

Arcutis Announces Third Quarter 2024 Financial Results and Provides Business Update

Third quarter net product revenues for ZORYVE® (roflumilast) franchise of $44.8M, with $22.0M for ZORYVE cream 0.3%, $20.3M for ZORYVE topical foam 0.3%, and $2.5M for ZORYVE cream 0.15%; sales growth of 452% vs. Q3 '23 and 45% vs. Q2 '24Continued gross-to-net (GTN) improvement with blended GTN across products now in the low 50 percent range, improving from the high 50 percent range last quarterSustained growth in prescriptions for both cream and foam, with total U.S. franchise unit demand increase of 25% quarter over quarterSupplemental New Drug Application (sNDA) for ZORYVE foam accepted by Food & Drug Administration (FDA) for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over with Prescription Drug User Fee Act (PDUFA) action date of May 22, 2025Announced Health Canada approval of ZORYVE foam for seborrheic dermatitis on October 18 and plan to commercially launch by end of 2024 WESTLAKE VILLAGE, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended September 30, 2024, and provided a business update. “Arcutis continues to execute our strategy successfully, with 45% revenue growth this quarter, marking sequential quarter growth since January of 2023. Product revenue for the quarter was driven by strong demand growth, and product preference by both patients and providers for ZORYVE across our three approved indications, as well as continued improvements in GTN. We are in the early stages of our launch of ZORYVE cream in mild to moderate atopic dermatitis, which has been well received for its effective, safe, and well-tolerated profile,” said Frank Watanabe, president and chief executive officer. “We have a strong revenue trajectory for the future, with a large addressable market that will continue to expand with further Medicaid wins, expected Medicare coverage wins, expansion into pediatric and primary care practices, and an expected FDA approval next year of ZORYVE foam for scalp and body psoriasis. We also continue to progress our pipeline, with the last subject enrolled in our ARQ-255 alopecia areata phase 1 trial and steady progress towards an IND for ARQ-234. Our strong balance sheet positions us to fuel our growth.” Program Updates / Key Milestones ZORYVE cream - a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in a once-daily cream formulation, approved in the United States for the treatment of plaque psoriasis and atopic dermatitis U.S. demand for ZORYVE cream in plaque psoriasis continues to grow, with over 304,000 prescriptions filled to date since launch by over 14,000 unique prescribers, reflecting the high levels of patient and physician satisfaction with the ZORYVE cream clinical profile. ZORYVE cream is covered by the three largest Pharmacy Benefit Managers (PBMs) and multiple other commercial insurers, and the Company expanded its Medicaid coverage to four additional states, Michigan, Arizona, California and Indiana, and anticipates it will obtain Medicaid coverage in additional states during 2024. ZORYVE cream 0.3% saw some GTN improvement in the third quarter compared to Q2 '24, and is approaching its steady state GTN.The FDA approved ZORYVE cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children down to age 6 in early Q3, and the Company commenced the commercial launch at the end of July. ZORYVE cream 0.15% is already covered as a line extension by two of the largest national PBMs, and the company anticipates continued improvement in coverage through the remainder of 2024, which will translate into improving GTN for ZORYVE cream 0.15% and the portfolio. ZORYVE foam - a once-daily foam formulation of topical roflumilast designed to overcome the challenges of delivering topical drugs in hair-bearing areas of the body, approved in the United States for the treatment of seborrheic dermatitis, and under FDA review for scalp and body psoriasis The launch of ZORYVE foam in seborrheic dermatitis continues to progress well, with over 168,000 prescriptions filled since launch, reflecting the high unmet need in this disease. ZORYVE foam is also covered by the three largest PBMs, and coverage for the foam is steadily improving, as evidenced by its favorable GTN, which is expected to approach steady state by the end of 2024.The Company submitted an sNDA for ZORYVE foam for scalp and body psoriasis to the FDA based on the positive results from the pivotal ARRECTOR Phase 3 trial and a Phase 2b trial, which was accepted by the FDA in September with a PDUFA action date set for May 22, 2025.The Company announced Health Canada approval of ZORYVE foam for seborrheic dermatitis on October 18, and anticipates making the foam commercially available in Canada prior to the end of 2024. ARQ-255 - a topical suspension formulation of ivarmacitinib, a potent and highly selective topical Janus kinase type 1 (JAK1) inhibitor, designed to preferentially deliver the drug deep into the hair follicle, in order to potentially treat alopecia areata at the site of inflammation In September 2024, Arcutis announced that it completed enrollment in a Phase 1b study evaluating ARQ-255 for the treatment of alopecia areata, with data expected in 1H '25. ARQ-234 - a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 Receptor (CD200R), being developed as a potential biologic treatment in atopic dermatitis The Company has continued preclinical development efforts and is working towards submitting an Investigational New Drug Application (IND) in 2025. Recent Corporate Highlights In July, the Company announced a co-promotion agreement with Kowa Pharmaceuticals America, Inc., whereby Kowa markets and promotes ZORYVE cream and ZORYVE foam to primary care practitioners and pediatricians for all FDA approved indications in the United States. Kowa began promoting ZORYVE in the second half of September.Amended the $200 million term-loan with SLR Investment Corp., lowering the interest rate, extending the maturity to August 2029, and obtaining an option to prepay up to $100 million of the principal and re-draw it by the first half of 2026 at the Company’s discretion. The Company made a partial prepayment of the principal of $100 million on October 8, 2024.Obtained two new U.S. patents in Q3 2024 related to ZORYVE. These patents cover, in part, formulations and methods of treatment resulting in unexpected and beneficial properties of ZORYVE, including the beneficial pharmacokinetic profile of ZORYVE. Arcutis also obtained a new U.S. patent covering the novel formulation of ARQ-255. Published positive results from two pivotal Phase 3 studies (INTEGUMENT-1 and INTEGUMENT-2) evaluating the efficacy and safety of ZORYVE cream 0.15% as a once-daily, steroid-free treatment for mild to moderate atopic dermatitis in the Journal of American Medical Association Dermatology (JAMA Dermatology). ZORYVE nominated for the Prix Galien USA for "Best Biotechnology Product", the world's highest independent distinction that awards the most critical products approved by the FDA in the last five years that demonstrate tremendous potential to improve human health. Board of Directors (Board) unanimously elected Keith Leonard as chair of the Board effective November 4, 2024, succeeding Patrick Heron. Mr. Leonard has served on the Board since 2021 and has more than 30 years of biopharmaceutical experience, including multiple chair, board director, and chief executive officer roles at publicly listed companies, and deep expertise in pharmaceutical commercialization. Mr. Heron, who has served on the Board since its formation and chair of the Board since 2019, will continue to serve as an independent director. Third Quarter 2024 Summary Financial Results Product revenues for the quarter ended September 30, 2024 were $44.8 million compared to $8.1 million for the corresponding period in 2023. Revenues for the quarter were $22.0 million for ZORYVE cream 0.3%, $20.3 million for ZORYVE topical foam 0.3%, and $2.5 million for ZORYVE cream 0.15%. Year-over-year and quarter-over-quarter increases were due to strong unit demand as well as GTN improvements. Across ZORYVE cream and ZORYVE foam, blended GTN is now in the low 50s, driven by the high percentage of prescriptions being reimbursed. Cost of sales for the quarter ended September 30, 2024 were $5.5 million compared to $1.2 million for the corresponding period in 2023. Research and development (R&D) expenses for the quarter ended September 30, 2024 were $19.5 million compared to $26.2 million for the corresponding period in 2023. The year-over-year decrease was due to decreased clinical development costs related to our topical roflumilast program. Selling, general, and administrative (SG&A) expenses for the quarter ended September 30, 2024 were $58.8 million compared to $47.6 million for the corresponding period in 2023. The year-over-year increase was primarily due to sales and marketing expenses related to the launches of ZORYVE cream and foam. Net loss was $41.5 million, or $0.33 per basic and diluted share, for the quarter ended September 30, 2024 compared to $44.8 million, or $0.73 per basic and diluted share, for the corresponding period in 2023. Cash, cash equivalents, restricted cash, and marketable securities were $331.2 million as of September 30, 2024, compared to $272.8 million as of December 31, 2023. Net cash used in operating activities was $34.7 million during the third quarter, an improvement of 23% compared to Q2 '24. On October 8th, the Company made a partial prepayment of $100M of the outstanding debt under the SLR loan.Conference Call and Webcast Arcutis management will host a conference call and webcast today at 4:30 pm ET to discuss the financial results for the quarter and provide a business update. The webcast for this conference call may be accessed at the “Events” section of the Company’s website. The replay of the webcast will be available on the Arcutis website following the call. About Arcutis Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including three FDA approved products that harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit https://www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. Forward Looking Statements Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for its topical drugs in development to address large markets with significant unmet need; the development, approval and potential commercialization of Arcutis' product candidates; the potential continued commercial success and growth of ZORYVE cream 0.3% in plaque psoriasis, ZORYVE cream 0.15% in atopic dermatitis and ZORYVE foam 0.3% in seborrheic dermatitis, including market access and reimbursement, product demand growth and continued improvement in GTN; and the timing of regulatory filings and potential approvals for a number of dermatology indications for roflumilast in the United States and Canada. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, the timing, expenses, and success of our commercialization efforts, including uncertainty of future commercial sales and related items that can impact net sales, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Contacts: MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsLatha Vairavan, VP Finance and Corporate Controllerir@arcutis.com ARCUTIS BIOTHERAPEUTICS, INC.Condensed Consolidated Balance Sheets(In thousands) September 30,2024 December 31,2023 (unaudited) ASSETS Current assets: Cash and cash equivalents$134,851 $88,398 Restricted cash 617 925 Marketable securities 195,710 183,463 Trade receivable, net 60,119 25,807 Inventories 14,015 13,134 Prepaid expenses and other current assets 18,408 18,704 Total current assets 423,720 330,431 Property and equipment, net 1,186 1,539 Intangible assets, net 9,792 6,438 Operating lease right-of-use asset 2,060 2,361 Other assets 596 596 Total assets$437,354 $341,365 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$19,325 $11,992 Accrued liabilities 52,790 33,941 Current portion of long-term debt, net 99,513 — Operating lease liability 798 735 Total current liabilities 172,426 46,668 Operating lease liability, noncurrent 2,772 3,382 Long-term debt, net 105,095 201,799 Other long-term liabilities 420 849 Total liabilities 280,713 252,698 Stockholders’ equity: Common stock 12 9 Additional paid-in capital 1,267,251 1,070,558 Accumulated other comprehensive loss 533 4 Accumulated deficit (1,111,155) (981,904)Total stockholders’ equity 156,641 88,667 Total liabilities and stockholders’ equity$437,354 $341,365 ARCUTIS BIOTHERAPEUTICS, INC.Condensed Consolidated Statements of Operations(In thousands, except share and per share data)(unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenues: Product revenue, net$44,755 $8,109 $97,182 $15,660 Other revenue — 30,000 28,000 30,420 Total revenues 44,755 38,109 125,182 46,080 Operating expenses: Cost of sales 5,503 1,182 12,223 2,741 Research and development 19,501 26,236 61,940 86,800 Selling, general, and administrative 58,817 47,595 171,784 136,471 Total operating expenses 83,821 75,013 245,947 226,012 Loss from operations (39,066) (36,904) (120,765) (179,932) Other income (expense): Other income, net 4,182 2,721 13,455 9,114 Interest expense (6,653) (7,559) (21,617) (21,950) Loss before income taxes (41,537) (41,742) (128,927) (192,768) Provision for income taxes — 3,023 324 3,088 Net loss$ (41,537) $ (44,765) $ (129,251) $ (195,856) Per share information: Net loss per share, basic and diluted$ (0.33) $ (0.73) $ (1.08) $ (3.19)Weighted-average shares used in computing net loss per share, basic and diluted 124,302,317 61,727,278 119,627,687 61,462,025

Clinical ResultPhase 3Phase 2Phase 1Drug Approval

22 Oct 2024

·www.prnewswire.com

JAK Inhibitors Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 50+ Companies Working in the Domain

JAK inhibitors are a class of medications that work by blocking Janus kinases (JAKs), enzymes that are involved in the signaling pathways of various cytokines and growth factors. JAK inhibitors offer a more targeted approach to treating immune-mediated diseases compared to traditional therapies like corticosteroids or conventional immunosuppressants; this specificity reduces side effects and increases efficacy and is a major driver for the demand for JAK inhibitors. LAS VEGAS, Oct. 22, 2024 /PRNewswire/ -- DelveInsight's ' JAK Inhibitors Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline JAK inhibitors in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the JAK inhibitors pipeline domain. Key Takeaways from the JAK Inhibitors Pipeline Report DelveInsight's JAK inhibitors pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline JAK inhibitors. Key JAK inhibitors companies such as Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical and others are evaluating new JAK Inhibitors drugs to improve the treatment landscape. Promising pipeline JAK inhibitors such as Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others are under different phases of JAK inhibitors clinical trials. In October 2024, Pelabresib in combination with ruxolitinib showed benefit in treating patients with JAK Inhibitor-Naïve Myelofibrosis significantly reduced splenomegaly, and improved anemia that has not been previously treated with Janus kinase inhibitors (JAKis). In September 2024, Eli Lilly and Company and EVA Pharma announced that the companies have agreed to expand access to baricitinib to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. In May 2024, Ajax Therapeutics, Inc., announced that it had received clearance for its Investigational New Drug application from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical study of AJ1–11095, a first-in-class Type II JAK2 inhibitor, for the treatment of patients with myelofibrosis. In February 2024, Novartis announced that it intends to acquire MorphoSys. The acquisition, which was unanimously approved by the boards of both Novartis and MorphoSys, is expected to close in the first half of 2024, subject to customary closing conditions. In January 2024, NS Pharma received orphan drug designation (ODD) from the European Commission (EC) for NS-229, which is being developed to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease. In December 2023, Sun Pharmaceuticals Inc. announced that it has entered a licensing agreement with Aclaris Therapeutics Inc., the company announced in a regulatory filing. Under the agreement, Aclaris granted Sun Pharma exclusive rights under certain patents for the use of deuruxolitinib, Sun Pharma's JAK inhibitor, or other isotopic forms of ruxolitinib, to treat alopecia areata (AA) or androgenetic alopecia (AGA). Request a sample and discover the recent advances in JAK inhibitors drugs @ JAK Inhibitors Pipeline Report The JAK inhibitors pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage JAK inhibitors drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the JAK inhibitors clinical trial landscape. JAK Inhibitors Overview Janus kinase (JAK) inhibitors are a class of medications designed to interfere with the activity of the Janus kinase family of enzymes, which play a crucial role in the signaling pathways of immune responses. These enzymes are key mediators in transmitting signals from cytokines and growth factors, which regulate blood cell production and immune system function. By blocking these signals, JAK inhibitors help to control the overactive immune response seen in several inflammatory and autoimmune diseases. They have shown significant efficacy in treating conditions like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, among others. The most common JAK inhibitors include tofacitinib, baricitinib, and upadacitinib, which are administered orally. Beyond their role in autoimmune diseases, JAK inhibitors are also being explored for use in treating certain cancers and myeloproliferative disorders, where abnormal JAK signaling contributes to uncontrolled cell growth. In diseases like myelofibrosis and polycythemia vera, JAK inhibitors can help reduce symptoms and improve quality of life. However, there are potential side effects associated with their use, including increased susceptibility to infections, blood clots, and cardiovascular risks, given their impact on the immune system. As research continues, the therapeutic potential of JAK inhibitors is expanding, offering new hope for patients with difficult-to-treat conditions. Find out more about JAK inhibitors drugs @ JAK Inhibitors Analysis A snapshot of the Pipeline JAK Inhibitors Drugs mentioned in the report: Learn more about the emerging JAK inhibitors @ JAK Inhibitors Clinical Trials JAK Inhibitors Therapeutics Assessment The JAK inhibitors pipeline report proffers an integral view of the emerging JAK inhibitors segmented by stage, product type, molecule type, and route of administration. Scope of the JAK Inhibitors Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Key JAK Inhibitors Companies: Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical, and others. Key JAK Inhibitors Pipeline Therapies: Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others. Dive deep into rich insights for new JAK inhibitors, visit @ JAK Inhibitors Drugs Table of Contents For further information on the JAK inhibitors pipeline therapeutics, reach out @ JAK Inhibitors Therapeutics Related Reports JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Eli Lilly and Company, Suzhou Zelgen Biopharmaceuticals Co., Ltd, Incyte Corporation, Kartos Therapeutics, Inc., Dompé Farmaceutici S.p.A, Sanofi, Kiniksa Pharmaceuticals, Ltd., Celgene, Abivax S.A., Telios Pharma, Inc., AstraZeneca, Karyopharm Therapeutics Inc, TWi Biotechnology, Inc., Geron Corporation, Ajax Therapeutics, Inc., among others. JAK Inhibitors Competitive Landscape JAK Inhibitors Competitive Landscape – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Pfizer, Sierra Oncology, Theravance Biopharma, Dizal Pharmaceutical, Aclaris Therapeutics, Celon Pharma, Incyte Corporation, AbbVie, Galapagos, among others. KRAS Inhibitors Market KRAS Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key KRAS inhibitors companies, including Novartis, Roche, Genentech, Verastem Oncology, Revolution Medicines, Cardiff Oncology, Immuneering Corporation, Jacobio Pharmaceuticals, BridgeBio Pharma, Mirati Therapeutics, Deciphera Pharmaceuticals, Elicio Therapeutics, InventisBio, Gritstone Bio, D3 Bio , among others. 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Phase 1License out/inAcquisitionOrphan Drug

05 Sep 2024

·www.globenewswire.com

Arcutis Completes Enrollment of Phase 1b Alopecia Areata Study Evaluating ARQ-255

ARQ-255 is a topical Janus kinase 1 (JAK1) inhibitor suspension formulated as a potential topical treatment for alopecia areataProprietary Deep Dermal Drug Delivery (4D) technology formulated to deliver drug deep into the skin to the base of the hair follicle where alopecia areata inflammation occursPhase 1b results expected first half of 2025 WESTLAKE VILLAGE, Calif., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the enrollment of the last subject in the Phase 1b study evaluating ARQ-255, a topical suspension of ivarmacitinib, a potent and selective JAK1 inhibitor, for the treatment of alopecia areata. ARQ-255 has been specifically formulated with Arcutis’ proprietary 4D technology to deliver drug deep into the skin to the base of the hair follicle, the site of the inflammation that underlies alopecia areata. “Alopecia areata affects approximately 1 in 500 people, yet today there are no FDA approved topical treatments for this devastating condition,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “The safety, tolerability, and pharmacokinetics data generated from this first-in-human study will provide valuable information to inform our ARQ-255 clinical development program and advance our vision of bringing innovation to the treatment of immune-mediated skin conditions where there has been little advancement in decades.” The Phase 1b, vehicle-controlled, double-blind, multicenter study is evaluating the safety, tolerability, pharmacodynamics, and pharmacokinetics of ARQ-255 topical suspension or vehicle in healthy adult volunteers and individuals with patchy alopecia areata (n=44). Results from the study are expected to be reported in the first half of 2025. About ARQ-255ARQ-255, or topical ivarmacitinib suspension, is a topical JAK1 inhibitor therapy for alopecia areata. Topical treatment of alopecia areata is challenging due to the depth of inflammation. ARQ-255 has been uniquely formulated to deliver drug deeper into the skin to reach the site of inflammation at the base of the hair follicle in alopecia areata. About Alopecia AreataAlopecia areata is an autoimmune condition that affects about 1 in 500 adults and occurs in individuals of all ages, sexes, and ethnic groups. In alopecia areata, the immune system attacks the body’s own hair follicles—leading to the development of patches of hair loss (alopecia) on the scalp, face, and other areas of the body. Typically, these bald patches appear suddenly and, in some patients, can progress to involve the entire body. Recurrence is common and many patients will experience several episodes during their lifetime. About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including three FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X. Forward-Looking StatementsArcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the timing and potential for clinical results for ARQ-255 and for the continuation of the clinical development program. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, and the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsLatha Vairavan, Vice President, Finance and Corporate Controllerir@arcutis.com

Phase 1Immunotherapy

100 Deals associated with Ivarmacitinib

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Alopecia Areata	NDA/BLA	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	05 Sep 2024
Rheumatoid Arthritis	NDA/BLA	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	04 Nov 2023
Ankylosing Spondylitis	NDA/BLA	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	24 Aug 2023
Dermatitis, Atopic	NDA/BLA	CN	Reistone Biopharma Co. Ltd.Startup	09 Jun 2023
Dermatitis, Atopic	NDA/BLA	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	09 Jun 2023
Non-radiographic axial spondyloarthritis	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	16 Aug 2022
Colitis, Ulcerative	Phase 3	US	Reistone Biopharma Co. Ltd.Startup	05 Nov 2021
Colitis, Ulcerative	Phase 3	CN	Reistone Biopharma Co. Ltd.Startup	05 Nov 2021
Colitis, Ulcerative	Phase 3	GE	Reistone Biopharma Co. Ltd.Startup	05 Nov 2021
Colitis, Ulcerative	Phase 3	PL	Reistone Biopharma Co. Ltd.Startup	05 Nov 2021

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04811131 (CTgov)	Phase 2	Nonsegmental vitiligo	114	NB-UVB phototherapy active treatment+ARQ-252 cream 0.3% (Active IP and Active Phototherapy)	qbiubtfsvx(fxrvdwmlmj) = ukgbhtbvuv qvdctjhmdi (cmqxmeidaw, nmwdzdalnt - hnhdotufsz) View more	-	12 Jul 2024
				NB-UVB phototherapy sham treatment+ARQ-252 cream 0.3% (Active IP and Sham Phototherapy)	qbiubtfsvx(fxrvdwmlmj) = vjwpyruwwj qvdctjhmdi (cmqxmeidaw, pmqclcozoq - rwoaymqhth) View more
NEWS Manual	Phase 2/3	Ankylosing Spondylitis	373	SHR0302 4mg	njbibldcgg(timndbifja) = ipuozsizyp fhdtpzwzop (hnmvdvtuvk ) View more	Positive	15 Jun 2024
				Placebo	njbibldcgg(timndbifja) = ygwavpilvl fhdtpzwzop (hnmvdvtuvk ) View more
NCT04333771 (EULAR 12024 \| EULAR 22024) Manual	Phase 3	Rheumatoid Arthritis	566	SHR0302 4mg	eqadfdyhag(ekuazajuyl) = hktywgovjt ifrragkxsy (ajyplcwhpv ) View more	Positive	12 Jun 2024
				SHR0302 8mg	eqadfdyhag(ekuazajuyl) = pjsxlqmdko ifrragkxsy (ajyplcwhpv ) View more
NCT04481139 (EULAR2024) Manual	Phase 2/3	Ankylosing Spondylitis	350	SHR0302 4 mg	bgyyvjwwqt(dfkimccjll) = mnltoehari dhatcrpftx (qdcqnsxuny ) View more	Positive	05 Jun 2024
				Placebo	bgyyvjwwqt(dfkimccjll) = rdppypkilk dhatcrpftx (qdcqnsxuny ) View more
NCT04378569 (CTgov)	Phase 1/2	Chronic eczema	230	ARQ-252 Cream (Cohort 1: ARQ-252 Cream 0.3% QD)	lertynawal(vavisutwym) = yqyjglyzml stycgmqyrf (rnctjtxiwv, luzxmwkjmt - wwyubvkvwe) View more	-	05 Apr 2024
				ARQ-252 Cream (Cohort 2: ARQ-252 Cream 0.3% QD)	ywsosovomu(lmyfxofsco) = mdkrwisufr fmmfjbjwoj (kpktvsdywe, vpomrmkbey - judhojkjlp) View more
ASH2023	Phase 1	Chronic graft-versus-host disease First line	18	SHR0302	adaccliner(mswkmgvgif) = sgqtdznfth uhhqopbzby (owzjlpapth ) View more	-	10 Dec 2023
NCT04162899 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis \| Dermatitis, Atopic	105	Drug: SHR0302 (Active Comparator: SHR0302 Dose A)	jpgnjhjjuk(ppahifiezu) = qdmcqjkthr miqgbgqwqq (eqryrhmqob, dhbugxjmfp - dwwmtxlyxl) View more	-	09 May 2023
				Drug: SHR0302 (Active Comparator: SHR0302 Dose B)	jpgnjhjjuk(ppahifiezu) = uqenruhktf miqgbgqwqq (eqryrhmqob, ffydnpqcel - gmvvdoypty) View more
NCT04875169 (QUARTZ3, Corporate Publications) Manual	Phase 3	Dermatitis, Atopic	336	Ivarmacitinib 8 mg	hvlvbiioyi(ebilmdihgy) = omtlshhwsq ywlocxryyq (cztziwtpmr ) Met View more	Positive	18 Mar 2023
				Ivarmacitinib 4 mg	hvlvbiioyi(ebilmdihgy) = qgaexktuoq ywlocxryyq (cztziwtpmr ) Met View more
ASH 12022 \| ASH 22022 Manual	Phase 1	Graft vs Host Disease First line	18	Prednisone+Ivarmacitinib	dqilaggfhx(wgkpxeahlh) = zrophkopcq thmwhqxqod (dpsogakuok ) View more	Positive	15 Nov 2022
Phase II Study (EADV2022)	Phase 2	Alopecia Areata	94	Ivarmacitinib 2mg	zcwbcsxzwf(dmyogthupe) = zyxututxrr dajgryiqkq (ulykxkdgtc )	Positive	07 Sep 2022
				Ivarmacitinib 4mg	zcwbcsxzwf(dmyogthupe) = hzvqypetpw dajgryiqkq (ulykxkdgtc, P=0.019)

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