JAK inhibitors - Competitive Landscape, 2023

This “JAK inhibitors - Competitive landscape, 2023” report provides comprehensive insights about 40+ companies and 45+ drugs in 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

JAK inhibitors: Understanding

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 December 2022, Incyte and CMS Aesthetics announced that the companies had entered into a Collaboration and License Agreement for the development and commercialization of ruxolitinib cream, a novel cream formulation of Incyte's selective JAK inhibitor ruxolitinib, for the treatment of autoimmune and inflammatory dermatologic diseases in Greater China and certain countries in Southeast Asia.
• 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 June 2022, Eli Lilly and Incyte announced that the US Food and Drug Administration (FDA) had approved OLUMIANT® (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA), available as 4-mg, 2-mg and 1-mg tablets.
• In July 2022, AbbVie announced that it has submitted applications for a new indication to the US 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 US 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 US 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.

 

JAK inhibitors: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Eli Lilly and Company

Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. The company was founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today it remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. Lilly is working with hospitals, healthcare professionals and governments to facilitate patient access to baricitinib and continues to explore the medicine's potential use in COVID-19 with other regulatory agencies outside the US. With respect to supply, Lilly remains confident in being able to meet the needs of patients under the EUA in the US, as well as for existing approved indications around the world.

Product Description: OLUMIANT

OLUMIANT is a once-daily, oral JAK inhibitor approved in the US for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the US for patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs. Olumiant is also approved in the European Union for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases. OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known. It is approved in the US and more than 75 countries as a treatment for adults with moderate to severe rheumatoid arthritis and is approved in more than 50 countries, including the European Union and Japan, for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.

2. 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 giant cell arteritis and Vasculitis arteritis are ongoing.

JAK inhibitors: Company and Product Profiles (Pipeline Therapies)

1. 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 a potent small molecule inhibitor of the Janus kinase family of enzymes (JAKs), with preferential selectivity for JAK1. 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 Ulcerative colitis, and 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. The drug is in Phase III for the treatment of axial spondylarthritis.

2. Company Overview: Incyte

Incyte's science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company's research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function. Currently, Incyte is exploring the potential of JAK inhibition for additional immune-mediated dermatologic conditions with a high unmet medical need, including hidradenitis suppurativa.

Product Description: Povorcitinib

Povorcitinib (INCB054707) is an oral small-molecule JAK1 inhibitor currently in Phase 2 clinical trials for hidradenitis suppurativa (HS), vitiligo and prurigo nodularis. The chemical structure for povorcitinib was revealed in WHO proposed INN list 126 (Jan 2022), in which it was described as a Janus kinase inhibitor and anti-inflammatory agent. It is currently being investigated in Phase III stage of development for the treatment of Hidradenitis Suppurativa and in Phase II clinical trials for Prurigo Nodularis and Vitiligo.

3. Company Overview: MaxiNovel Pharmaceuticals

MaxiNovel Pharmaceuticals Co.,Ltd. is a China based biotech company founded in 2016 to focus on the innovative drug research with the global intellectual property rights. The company carry out first-in-class small molecule drug discovery in the areas of targeted therapy and immunotherapy. Our rapidly expanding product pipeline is mainly composed of programs that target both blood tumors and solid tumors as well as autoimmune diseases. Company's research platforms encompass oral therapy, radiotherapy, imaging and transdermal therapy. The company have their R&D and operation centres in China (Shanghai, Guangzhou, and Shenzhen), the United States and Australia. The management team members all have extensive previous working experiences in global pharmaceutical companies and capital markets, more importantly global vision of our company's future development. The mission of the company is to conduct pharmaceutical innovation to save lives and bring hopes to patients and their families.

Product Description: MAX-40279

MAX-40279 is the first new molecular entity (NME) from Maxinovel pipeline that has progressed to proof-of-mechanism/concept stage of clinical development. It was granted orphan drug designation by the US FDA in 2018 and also supported by the Chinese National Key Grant Program for New Drug Development in 2019. Currently, the drug is being evaluated in the Phase II for the treatment in patients with Gastric cancer and Oesophageal cancer. Multiple Phase I/II clinical trials in acute myeloid leukemia (AML) and solid tumors are currently ongoing in Australia and China. The primary mechanism of action for MAX-40279 in AML is to overcome resistance to FGFR bypass activation with FLT3 inhibitors through effective inhibition of the dual FLT3/FGFR targets. MAX-40279 also has multiple inhibitory mechanisms in solid tumors: preclinical studies have shown inhibition of multiple tyrosine kinases by MAX-40279. In addition, MAX-40279 can inhibit hematopoietic progenitor kinase 1 (HPK1) and relieve the negative regulation of HPK1 on T cell receptor (TCR) pathway. Furthermore, through translational research, Maxinovel scientists identified a potential biomarker, an adaptor protein that can bind to multiple tyrosine kinases, may be predictive of response to MAX-40279 treatment.

4. Company Overview: MaxiNovel Pharmaceuticals

MaxiNovel Pharmaceuticals Co.,Ltd. is a China based biotech company founded in 2016 to focus on the innovative drug research with the global intellectual property rights. The company carry out first-in-class small molecule drug discovery in the areas of targeted therapy and immunotherapy. Our rapidly expanding product pipeline is mainly composed of programs that target both blood tumors and solid tumors as well as autoimmune diseases. Company's research platforms encompass oral therapy, radiotherapy, imaging and transdermal therapy. The company have their R&D and operation centres in China (Shanghai, Guangzhou, and Shenzhen), the United States and Australia. The management team members all have extensive previous working experiences in global pharmaceutical companies and capital markets, more importantly global vision of our company's future development. The mission of the company is to conduct pharmaceutical innovation to save lives and bring hopes to patients and their families.

Product Description: MAX-40070

MAX-40070 is a topical JAK/Tyk2 inhibitor developed by Maxinovel. Oral JAK inhibitors have shown their efficacy in treating a variety of autoimmune skin diseases and preventing disease progression in clinical trials and medical practice. The liniment formulation inhibits the JAK family (JAK1, JAK2, JAK3 and Tyk2) kinase activity in the localized skin lesions through the topical administration while avoiding systemic high exposure, thereby blocking the signal cascade of JAK-STAT pathogenic pathway. Currently, the drug is in Phase I stage of development for the treatment of Alopecia Areata.

JAK inhibitors Analytical Perspective

In-depth Commercial Assessment: JAK inhibitors Collaboration Analysis by Companies

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.

• JAK inhibitors Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

JAK inhibitors Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions Answered

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing JAK inhibitors drugs?
• How many 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 JAK inhibitors?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the 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 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.
• MaxiNovel Pharmaceuticals

Key Products

• PF-06651600
• Momelotinib
• TD-8236
• DZD4205
• TD-0903
• TD-5202
• ATI-2138
• CPL409116
• Itacitinib
• Ruxolitinib
• Upadacitinib
• Filgotinib
• Ivarmacitinib
• MAX-40070

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