Janus kinase (JAK) Inhibitors- Competitive Landscape, 2022

Janus kinase (JAK) Inhibitors- Competitive Landscape, 2022

DelveInsight’s, “Janus kinase (JAK) inhibitors- Competitive landscape, 2022,” report provides comprehensive insights about 40+ companies and 45+ drugs in Janus kinase (JAK) inhibitors Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Geography Covered • Global coverage Janus kinase (JAK) inhibitors: Understanding Janus kinase (JAK) inhibitors: Overview Janus kinase (JAK) inhibitors are small molecules approximately 400 Da that could be administrated as oral medicines. JAKs are phosphotransferases that bind to the intracellular domains of cytokine receptors and transmit signals to activate immune responses. The family of cytokines that signal via JAKs includes many interleukins, interferons, colony stimulating factors and hormone like cytokines (such as erythropoietin). The receptors for these cytokines signal via various combinations of four JAKs (JAK1, JAK2, JAK3 and TYK2). First-generation jakinibs, such as tofacitinib and baricitinib (and oclacitinib in dogs), block more than one JAK, and thereby can inhibit a large number of cytokines; these and other pan-jakinibs are being investigated as therapeutic agents for a wide variety of autoimmune diseases. Janus kinase (JAK) inhibitors (jakinibs) that target downstream signalling by a large range of cytokines are effective in treating autoimmune and rheumatic diseases. Common adverse effects include infection, anaemia, neutropenia, lymphopenia and hyperlipidaemia. These effects are expected owing to the inhibition of multiple JAKs and many cytokines and the rate of infections in patients treated with these drugs is similar to the rate with other immunosuppressive drugs and biologic agents. JAKs were recognized as a family of non-receptor tyrosine kinases which were composed of four members in mammals: JAK1, JAK2, JAK3 and tyrosine kinase 2 (TYK2). They transmit signals from cell membrane receptors to members of the signal transducer and activator of transcription (STAT) family. The JAK-STAT signaling pathway can be activated by a variety of cytokines, which are major contributors to a lot of immune-mediated diseases. Thus, inhibiting JAK-mediated signaling might benefit the treatment of autoimmune diseases. In fact, an overwhelming body of evidence has established that inhibition of JAK-STAT pathway is effective in rheumatoid arthritis (RA), psoriasis, and inflammatory bowel disease (IBD). Recently many of the cytokines involved in PsA pathogenesis are also identified to be mediated by JAK-STAT pathway such as those related to the interleukin (IL)-12/23 and IL-17 axes. Numerous cytokines signal via the JAK–STAT cascades, which are important for the immune response, host defense and inflammation. Moreover, cytokines are the major drivers in immune‐mediated disease. Therefore, it is no surprise that the blocking of several JAK kinase isoforms now is a new chapter in the treatment of several cancers and autoimmune diseases. Clinical trials with several JAK inhibitors are ongoing from cancer such as myelofibrosis to autoimmune diseases such as psoriasis. In the future, it is possible that several other JAK inhibitors also to be effective in multiple disorders therapy. Report Highlights • In September 2022, -Bristol Myers Squibb announced new two-year results from the POETYK PSO long-term extension (LTE) trial demonstrating clinical efficacy was maintained with continuous Sotyktu™ (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. This analysis assessed patients from the pivotal POETYK PSO-1 trial who transitioned into the LTE trial. At 112 weeks of Sotyktu treatment, modified non-responder imputation (mNRI) response rates were 82.4% for Psoriasis Area and Severity Index (PASI) 75, 55.2% for PASI 90 and 66.5% for static Physician's Global Assessment (sPGA) 0/1. • In July 2022, AbbVie announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ®, 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]) for the treatment of adult patients with moderately to severely active Crohn's disease. • In March 2022, AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. This FDA approval is the first indication for RINVOQ in gastroenterology and is supported by efficacy and safety data from three Phase 3 randomized, double-blind, placebo-controlled clinical studies. • In January 2022, AbbVie announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended. Company Profiles & their Late-stage Drug Profiles 1. Company Overview: AbbVie AbbVie has been dedicated to improving care for people living with rheumatic diseases. Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, ultimately helping more people living with rheumatic diseases reach their treatment goals. Product Description: RINVOQ Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. In the U.S., RINVOQ 15 mg is approved for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers; adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers; and adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.RINVOQ 45 mg is approved for use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers as an induction therapy once daily for 8 weeks. The recommended dose of RINVOQ for maintenance treatment is 15 mg once daily. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. RINVOQ 15 mg once daily can also be initiated in adults and children 12 years of age and older weighing at least 40 kg with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other system drug products, including biologics or when use of those therapies is inadvisable. Phase III trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing. 2. Company Overview: Galapagos Galapagos NV discovers, develops and commercializes small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Company’s pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biotech company focused on the discovery, development and commercialization of innovative medicines. Product Description: Filgotinib Filgotinib is approved and marketed as Jyseleca (200 mg and 100 mg tablets) in Europe and Japan for the treatment of adults with moderately to severely active RA who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). Filgotinib was submitted to the European Commission for an extended indication for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. 3. Company Overview: Theravance Biopharma Theravance Biopharma, Inc.'s overarching purpose and goal as a biopharmaceutical company is focused on delivering Medicines that Make a Difference in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Its pipeline of internally discovered programs is targeted to address significant unmet patient needs. Product Description: TD-8236 TD-8236 is an internally-discovered, lung-selective inhaled JAK inhibitor that has high affinity for each of the JAK family of enzymes. This JAK activity of TD-8236 is expected to impact a broad range of cytokines that have been associated with both Th2-high and Th2-low asthma. Many patients with both phenotypes remain symptomatic with currently available therapies, especially those with Th2-low asthma. Importantly, TD-8236 is designed to have optimal therapeutic exposure levels within the lungs while minimizing systemic exposure following dry powder inhalation. This drug profile has the potential to improve treatment of inflammation within that organ while reducing the risk adverse events from systemic immunosuppression. Further product details are provided in the report…….. Future of Competitive Landscape of JANUS KINASE (JAK) INHIBITORS is estimated to be very strong. Key emerging drugs include TD-8236, Filgotinib and many other. JANUS KINASE (JAK) INHIBITORS Analytical Perspective by DelveInsight • In-depth JANUS KINASE (JAK) INHIBITORS analysis: Assessment of Products The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition – deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form. • JANUS KINASE (JAK) INHIBITORS clinical assessment of products The report comprises of comparative clinical assessment of products by development stage, product type, and route of administration, molecule type. JANUS KINASE (JAK) INHIBITORS Report Assessment • Company Analysis • Therapeutic Assessment • Approved/Pipeline Assessment • Inactive drugs assessment • Unmet Needs Key Questions Current Treatment Scenario and Emerging Therapies: • How many companies are developing JANUS KINASE (JAK) INHIBITORS drugs? • How many JANUS KINASE (JAK) INHIBITORS drugs are developed by each company? • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of JANUS KINASE (JAK) INHIBITORS ? • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the JANUS KINASE (JAK) INHIBITORS therapeutics? • What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? • What are the clinical studies going on for JANUS KINASE (JAK) INHIBITORS and their status? • What are the key designations that have been granted to the emerging and approved drugs?   Key Players • Pfizer • Sierra Oncology • Theravance Biopharma • Dizal Pharmaceutical • Aclaris Therapeutics • Celon Pharma • Incyte Corporation • AbbVie • Galapagos • Gilead Sciences • Reistone Biopharma • Jiangsu Hengrui Medicine Co. Key Products • PF-06651600 • Momelotinib • TD-8236 • DZD4205 • TD-0903 • TD-5202 • ATI-2138 • CPL409116 • Itacitinib • Ruxolitinib • Upadacitinib • Filgotinib • Ivarmacitinib

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