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Rheumatoid Arthritis Pipeline & Clinical Trial Report | 95+ Companies & 100+ Drugs

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Rheumatoid Arthritis Pipeline & Clinical Trial Report | 95+ Companies & 100+ Drugs

January 12
20:17 2023

DelveInsight’s, “Rheumatoid Arthritis Pipeline Insight, 2023” report provides comprehensive insights about 95+ companies and 100+ pipeline drugs in the Rheumatoid Arthritis pipeline landscape. It covers the Rheumatoid Arthritis pipeline drug profiles, including Rheumatoid Arthritis clinical trial and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

 

Key takeaways from the Rheumatoid Arthritis Pipeline Report

  • DelveInsight’s rheumatoid arthritis pipeline report depicts a robust space with 95+ active players working to develop 100 + pipeline therapies for rheumatoid arthritis treatment.
  • The leading Rheumatoid Arthritis companies include Taisho Pharmaceutical, Zhejiang Hisun Pharmaceutical, SinoMab, Jiangsu Hengrui Medicine, RemeGen, GlaxoSmithKline, Modern Biosciences, Jiangsu Alphamab Biopharmaceuticals, Akros Pharma, Hanlim Pharm, Galapagos NV, Chong Kun Dang Pharmaceutical, Bristol Myers Squibb, AstraZeneca, Aclaris Therapeutics, Abivax, AbbVie, Synact Pharma, Gilead sciences, Mesoblast, Rottapharm Biotech, Eli Lilly and Company, Kiniksa Pharmaceuticals, Abcentra, Cyxone, Yungjin Pharm. Co., Ltd. Taiho Pharmaceutical, Oscotec Inc., Pfizer, Janssen Research & Development, Cipher Pharmaceuticals Inc., KLUS Pharma Inc., Revolo Biotherapeutics, Lynk Pharmaceuticals, Beijing Baylx Biotech, Hope Biosciences, Kangstem Biotech, Celltex Therapeutics, I-Mab Biopharma Co. Ltd., Synermore Biologics Co., Ltd, Oryn Therapeutics, Arthrogen, Bayer, Amgen, Draconis Pharma, Biozeus, Landos Biopharma, Imcyse, Kymera Therapeutics, RedHill Biopharma, 4D Pharma, CV6 Therapeutics, VYNE Therapeutics, MyMD Pharmaceuticals, Brickell Biotech Inc, Worg Pharmaceuticals, Almirall, Standigm, Metrion Biosciences, Jnana Therapeutics, Silo Pharma, SFA Therapeutics, Neutrolis Therapeutics, Ahead Therapeutics, Fresenius Kabi, Kidswell Bio, BioXpress Therapeutics, CinnaGen, Alvotech, Hetero Biopharma, Shanghai Henlius Biotech, Cadila Pharmaceuticals, Innovent Biologics, Torrent Pharmaceuticals, Emcure Pharmaceuticals, mAbxience, Shanghai Junshi Biosciences, Enosi Therapeutics, and others.
  • Promising Rheumatoid Arthritis Pipeline Therapies include TS152, HS-016, SM03, SHR0302, RC18, Otilimab, NI-0101, MBS2320, KN019, JTE-051, Interleukin 2, HL237, GLPG3970, Elsubrutinib, CKD-506, Branebrutinib, AZD9567, ATI-450, ABX464, ABBV 3373, ABBV 154, AP1189, F8IL10, AMT-101, GS-9876, CR 6086, LY 3462817, KPL-404, Orticumab, Rabeximod, YRA 1909, VIB4920, Varicella Zoster Vaccine, TAS5315, SKI-O-703, SAN-300, PF-06650833, Nipocalimab, CF-101, A223, IRL 201805, LNK 01001, PRTX-100, hUC-MSC infusion, HB-adMSC, LABP-104, VAY736, TJ003234 , SYN060, GS-5718, PF-06835375, Nivolumab, MH004, ORTD-1, ART-I02, FB704A, Amilo 5MER, CKD-374 , CFZ-533, BAY 1830839, AMG 570, JNJ-4703, CT-P47, BZ068, Invossa, LABP-69, ICM-203-R, NX-5948, KT-474 , Clarithromycin/clofazimine/rifabutin (RHB-104), Research programme: small molecule TYK2 inhibitors, MRx0006, CV6 1271, VYN201, MYMD-1, BBI 02, Research Programme: Immune mediated diseases, Foralumab, SPU-21, SFA002, NTR-441, Research programme: autoimmune disease therapeutics, AT_1001, MSB11456, MabionCD20, DMB-3113, GB232, GBS 005, TX17, BX 2922, Cinnora, AVT02, MYL-1401A, and others.
  • The Rheumatoid Arthritis Companies and academics are working to assess challenges and seek opportunities that could influence Rheumatoid Arthritis R&D. The Rheumatoid Arthritis pipeline therapies under development are focused on novel approaches to treat/improve Rheumatoid Arthritis.

 

Explore more about the latest breakthroughs of the Rheumatoid Arthritis Treatment Landscape @ Rheumatoid Arthritis Pipeline Outlook

 

Rheumatoid Arthritis Overview

Rheumatoid arthritis (RA) is an autoimmune or chronic inflammatory disease known to adversely impact the joints of the body. An autoimmune disorder is a condition where the immune system starts making antinuclear bodies instead of antibodies which directs them to cause self-injury to the body; on the onset of disease, the immune response primarily attacks and harms the joints. The disorder does not stay constrained to joints of hands and legs. It has the power to influence any part of the body that involves synovial fluid; approximately 30% of the people who suffer from RA experience pain and other remarkable signs and symptoms that do not involve joints, including heart, kidneys, salivary glands, nerve tissues, skin, eyes bone marrow, blood vessels. The exact cause of RA is still not known.

 

Recent Developmental Activities in the Rheumatoid Arthritis Treatment

  • In July 2022, Enosi Therapeutics, announced a partnership with Danuo Science Group, based in Hong Kong, to further develop two products currently in Enosi’s pipeline for Greater China. Enosi’s Growth Factor Trap (EN-2000 Program) and TNFR1 Blocker (EN-1000 Program) were licensed as part of the partnership. Both programs have the potential to be used as cross-over drugs to treat cancer and autoimmune diseases. EN-2000 blocks inflammatory growth factors that drive cancer and rheumatoid arthritis while EN-1000 is a specific blocker of TNFR1, which Enosi believes may be useful in treating autoimmune disease. 
  • In February 2022, Biogen Inc. and Xbrane Biopharma AB announced that they have entered into a commercialization and license agreement to develop, manufacture, and commercialize Xcimzane™, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA® (certolizumab pegol).
  • In June 2022, Biogen Inc. and Bio-Thera Solutions, Ltd. presented positive Phase III data for BIIB800 (BAT1806), a biosimilar candidate referencing. The double-blind 52-week Phase III study randomized 621 patients with moderate to severe rheumatoid arthritis to receive either BIIB800 or the reference tocilizumab administered intravenously every 4 weeks at a dose of 8 mg/kg for the first 24 weeks. Data from the Phase III comparative clinical trial demonstrated that the investigational biosimilar candidate BIIB800 has equivalent efficacy and comparable safety and immunogenicity profile to the reference tocilizumab product.
  • In June 2022, Revolo Biotherapeutics announced that it was awarded an Innovative Medicines Designation, or Innovation Passport, from the Medicines and Healthcare products Regulatory Agency (MHRA) for its immune-resetting drug candidate, ‘1805, for the treatment of patients with moderately to severely active Rheumatoid Arthritis (RA). In February 2022, Revolo Biotherapeutics secured approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to initiate two Phase II trials of its autoimmune disease drug candidate ‘1805. One of the trials will enrol moderate-to-severe active rheumatoid arthritis (RA) patients while another Phase II trial will have individuals with non-infectious, active, intermediate, or posterior uveitis or panuveitis.
  • In December 2021, Theramex, entered into an agreement with Enzene Biosciences Limited to develop, register, and commercialize a biosimilar drug of Roche’s reference medicine RoActemra (Tocilizumab). Tocilizumab, in combination with Methotrexate (MTX), is indicated for the treatment of rheumatoid arthritis. It is planned to be commercialized from 2026 in Europe, the UK, Switzerland, and Australia.
  • Obefazimod is an oral, first-in-class, small molecule being developed by Abivax in Phase II stage of development. Obefazimod generated promising pre-clinical data from collagen-induced arthritis animal models that were the basis for moving into the Phase IIa clinical trial in rheumatoid arthritis (RA).
  • Zunsemetinib, an Investigational Oral MK2 Inhibitor, is being developed by Aclaris Therapeutics. Aclaris initiated study activities and began activating sites in December 2021 in the following two studies: ATI-450-RA-202: Phase IIb clinical trial of zunsemetinib in subjects with moderate to severe rheumatoid arthritis (RA). This is Aclaris’ second Phase II clinical trial of zunsemetinib in subjects with moderate to severe RA and is primarily designed to assess the efficacy of multiple doses of zunsemetinib to aid in the selection of an optimal dose to progress in future development.

 

Find out more about Rheumatoid Arthritis Medications and Key Players @ Rheumatoid Arthritis Treatment Landscape

 

Rheumatoid Arthritis Emerging Drugs Profile

 

SM03: SinoMab

SM03, the company’s flagship product, is a potential global first-in-target anti-CD22 monoclonal antibody for the treatment of RA and potentially for the treatment of other immunological diseases.  CD22, an inhibitory coreceptor of the BCR, is a potential immunotherapeutic target against autoimmune diseases. SM03 could disturb the CD22 homomultimeric configuration through disrupting cis binding to α2,6-linked sialic acids, induce rapid internalization of CD22 from the cell surface of human B cells, and facilitate trans binding between CD22 to human autologous cells. This in turn increased the activity of the downstream immunomodulatory molecule Src homology region 2 domain-containing phosphatase 1 (SHP-1) and decreased BCR-induced NF-κB activation in human B cells and B cell proliferation. This mechanism of action gives rationale to support the significant amelioration of disease and good safety profile in clinical trials, as by enabling the “self” recognition mechanism of CD22 via trans binding to α2, 6 sialic acid ligands on autologous cells, SM03 specifically restores immune tolerance of B cells to host tissues without affecting the normal B cell immune response to pathogens.

 

This has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. As a potential global first-in-target mAb for the treatment of RA, SM03 is a recombinant immunoglobulin IgG1 monoclonal antibody. Currently the drug is in Phase III stage of Clinical trial evaluation for the treatment of Rheumatoid Arthritis.

 

SHR0302: Jiangsu Hengrui Medicine

SHR0302 is a potent and orally active all members of the JAK family inhibitor, particularly JAK1. The selectivity of SHR0302 for JAK1 is >10-fold for JAK2, 77-fold for JAK3, 420-fold for Tyk2. It inhibits JAK1/STAT3 phosphorylation and induces the apoptosis of hepatic stellate cells.

 

SHR0302 has an anti-proliferative and anti-inflammatory effect. Many inflammatory cytokines and other signaling molecules rely on the JAK pathway, and specifically JAK1, which plays a central role in immune system function. Inhibition of JAK1 has been shown to treat a range of inflammatory diseases, including rheumatoid arthritis, psoriasis, Crohn’s disease, and eczema. The drug is currently being evaluated in Phase III stage of clinical trial to treat Rheumatoid Arthritis.

 

RC18: RemeGen

RC18 is a novel recombinant TACI-Fc (transmembrane activator and calcium modulator and cyclophilin ligand interactor) fusion protein that was developed to treat autoimmune diseases. RC18 has a dual-targeting mechanism that inhibits the development and survival of plasma cells and mature B-cells implicated in several autoimmune diseases. RC18 works by binding to two cell-signaling molecules, a B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand. By only affecting mature B cells, RC18 has minimal impact on early and memory B cells, which are important for normal body immune function. RC18 is currently being studied in several late-stage clinical trials across autoimmune diseases, including Rheumatoid Arthritis and multiple sclerosis. A Phase III clinical trial is evaluating RC18 for the treatment of patients with Rheumatoid Arthritis.

 

Zalunfiban: CeleCor Therapeutics

Zalunfiban (RUC-4), a next generation GPI, is specifically designed to be administered subcutaneously to inhibit platelet aggregation for a first-point-of-medical contact treatment to improve outcomes for STEMI patients. Inhibiting platelet aggregation can slow or stop blood clot formation leading to coronary artery blockage, and in turn, can stop or prevent a heart attack.

 

Zalunfiban targets platelet GPIIb/IIIa receptors, the final common pathway in platelet aggregation, to inhibit all platelet activators and can, under some conditions, promote recanalization of occluded arteries. In contrast, other antiplatelet medications, including P2Y12 inhibitors and aspirin, inhibit only one platelet activator and have not been demonstrated to promote recanalization.

 

Further, due to decreased gastrointestinal absorption, oral P2Y12 inhibitors given before the procedure to open the artery do not act rapidly or reliably enough in STEMI patients during the crucial early minutes of a heart attack and have not demonstrated a clinical benefit to date. It is currently being investigated in Phase III stage of development for the treatment of Rheumatoid Arthritis.

 

ABBV-3373: Abbvie

Being developed by AbbVie, ABBV-3373 is an investigational ADC comprised of a novel glucocorticoid receptor modulator (GRM) linked to adalimumab and aims at modulating TNF-mediated inflammatory pathways by delivering a glucocorticoid payload directly into activated immune cells expressing membrane-bound TNF. This ADC was designed to potentially allow precise targeting of activated immune cells while significantly dampening inflammation and minimizing the systemic side-effects associated with glucocorticoids. ABBV-3373 is an investigational medicine that is not approved by regulatory authorities and is being studied in Phase II to treat RA and other immune-mediated diseases.

 

Dazodalibep: Horizon Therapeutics

Dazodalibep (HZN-4920, VIB 4920) is a CD40 ligand antagonist that blocks T cell interaction with CD40-expressing B cells, disrupting the overactivation of the CD40 ligand co-stimulatory pathway. Several autoimmune diseases are associated with the overactivation of this pathway. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Rheumatoid Arthritis.

 

AP1189: Synact Pharma

AP1189 is a first-in-class IP-protected biased agonist to the melanocortin type 1 (MCr1) and type 3 (MCr3) receptors. The MC1r and MC3r are present on key cells in the immune system, including neutrophils and macrophages. When the AP1189 compound activates the receptors, EKR 1/2 phosphorylation is activated, associated with several anti-inflammatory and pro-resolving effects. The compound thereby reduces ongoing inflammation but, compared to most other anti-inflammatory compounds, in addition, stimulate endogen pathways that promote facilitation on the clearance of the inflammation, i.e., resolution. The compound is currently in clinical Phase IIa where the compound is tested as an add-on to methotrexate treatment in previous MTX naive patients with active RA.

 

Dekavil: Philogen

Dekavil is an agonist, an antibody fragment fused to an immunoregulatory cytokine called IL-10. As a dual-functioning therapy, the antibody portion binds to a spliced variant of fibronectin that is increased at sites of inflammation. There is abundant expression at accessible tissue remodeling sites, while being undetectable in most normal human tissues It help reduce inflammation in multiple diseases, such as Rheumatoid Arthritis and ulcerative colitis. Anti-inflammatory cytokines, such as IL-10, help prevent inflammatory and autoimmune conditions. The binding of IL-10 to its receptor triggers a signaling pathway that ultimately limits the production of proinflammatory cytokines and chemokines, such as IL-1, IL-6, and TNF-α.

 

IL-10 plays a potential role in human diseases: In rheumatoid arthritis, the addition of IL-10 to synovial membrane cultures can decrease IL-1β and TNF-α expression. Similarly, blocking endogenous IL-10 can cause a 2- to 3-fold increase in the expression of these proinflammatory cytokines. Moreover, activating the IL-10 pathway has shown promise as a therapeutic strategy in preclinical mouse models.

 

Rheumatoid Arthritis Therapeutics Assessment

There are approx. 95+ key companies which are developing the therapies for Rheumatoid Arthritis. The companies which have their Rheumatoid Arthritis drug candidates in the most advanced stage, i.e. Phase I/II include, RHEACELL.

 

Learn more about the Rheumatoid Arthritis emerging therapies @ Rheumatoid Arthritis Ongoing Clinical Trials Analysis

 

Scope of the Rheumatoid Arthritis Pipeline Report

 

  • Coverage- Global
  • Rheumatoid Arthritis CompaniesTaisho Pharmaceutical, Zhejiang Hisun Pharmaceutical, SinoMab, Jiangsu Hengrui Medicine, RemeGen, GlaxoSmithKline, Modern Biosciences, Jiangsu Alphamab Biopharmaceuticals, Akros Pharma, Hanlim Pharm, Galapagos NV, Chong Kun Dang Pharmaceutical, Bristol Myers Squibb, AstraZeneca, Aclaris Therapeutics, Abivax, AbbVie, Synact Pharma, Gilead sciences, Mesoblast, Rottapharm Biotech, Eli Lilly and Company, Kiniksa Pharmaceuticals, Abcentra, Cyxone, Yungjin Pharm. Co., Ltd. Taiho Pharmaceutical, Oscotec Inc., Pfizer, Janssen Research & Development, Cipher Pharmaceuticals Inc., KLUS Pharma Inc., Revolo Biotherapeutics, Lynk Pharmaceuticals, Beijing Baylx Biotech, Hope Biosciences, Kangstem Biotech, Celltex Therapeutics, I-Mab Biopharma Co. Ltd., Synermore Biologics Co., Ltd, Oryn Therapeutics, Arthrogen, Amgen, Biozeus, Landos Biopharma, Imcyse, Kymera Therapeutics, RedHill Biopharma, 4D Pharma, CV6 Therapeutics, VYNE Therapeutics, MyMD Pharmaceuticals, Brickell Biotech Inc, Worg Pharmaceuticals, Almirall, Standigm, Metrion Biosciences, Jnana Therapeutics, Silo Pharma, SFA Therapeutics, Neutrolis Therapeutics, Ahead Therapeutics, Fresenius Kabi, Kidswell Bio, BioXpress Therapeutics, CinnaGen, Alvotech, Hetero Biopharma, Shanghai Henlius Biotech, Cadila Pharmaceuticals, Innovent Biologics, Torrent Pharmaceuticals, Emcure Pharmaceuticals, mAbxience, Shanghai Junshi Biosciences, Enosi Therapeutics, and others.
  • Rheumatoid Arthritis Pipeline Therapies- TS152, HS-016, SM03, SHR0302, RC18, Otilimab, NI-0101, MBS2320, KN019, JTE-051, Interleukin 2, HL237, GLPG3970, Elsubrutinib, CKD-506, Branebrutinib, AZD9567, ATI-450, ABX464, ABBV 3373, ABBV 154, AP1189, F8IL10, AMT-101, GS-9876, CR 6086, LY 3462817, KPL-404, Orticumab, Rabeximod, YRA 1909, VIB4920, Varicella Zoster Vaccine, TAS5315, SKI-O-703, SAN-300, PF-06650833, Nipocalimab, CF-101, A223, IRL 201805, LNK 01001, PRTX-100, hUC-MSC infusion, HB-adMSC, LABP-104, VAY736, TJ003234 , SYN060, GS-5718, PF-06835375, Nivolumab, MH004, ORTD-1, ART-I02, FB704A, Amilo 5MER, CKD-374 , CFZ-533, BAY 1830839, AMG 570, JNJ-4703, CT-P47, BZ068, Invossa, LABP-69, ICM-203-R, NX-5948, KT-474 , Clarithromycin/clofazimine/rifabutin (RHB-104), Research programme: small molecule TYK2 inhibitors, MRx0006, CV6 1271, VYN201, MYMD-1, BBI 02, Research Programme: Immune mediated diseases, Foralumab, SPU-21, SFA002, NTR-441, Research programme: autoimmune disease therapeutics, AT_1001, MSB11456, MabionCD20, DMB-3113, GB232, GBS 005, TX17, BX 2922, Cinnora, AVT02, MYL-1401A, and others.
  • Rheumatoid Arthritis Segmentation: Phases, Route of Administration, Mechanism of Action, Molecule Type, Product Type

 

Table of Content

  1. Introduction
  2. Rheumatoid Arthritis  Executive Summary
  3. Rheumatoid Arthritis: Overview
  4. Rheumatoid Arthritis  Pipeline Therapeutics
  5. Rheumatoid Arthritis  Therapeutic Assessment
  6. Rheumatoid Arthritis – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. SM03: SinoMab
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase  II)
  11. ABBV-3373: Abbvie
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I/II)
  14. SVT 6A4710: Servatus Biopharmaceuticals
  15. Drug profiles in the detailed report…..
  16. Early Stage Products (Phase I)
  17. SYN060: Synermore Biologics Co., Ltd.
  18. Drug profiles in the detailed report…..
  19. Preclinical Stage Products
  20. CABA-201: Cabaletta Bio
  21. Drug profiles in the detailed report…..
  22. Inactive Products
  23. Rheumatoid Arthritis  –  Collaborations Assessment- Licensing / Partnering / Funding
  24. Rheumatoid Arthritis  – Unmet Needs
  25. Rheumatoid Arthritis  – Market Drivers and Barriers
  26. Appendix

 

Get to know more information on Rheumatoid Arthritis pipeline therapeutics, reach out @ Rheumatoid Arthritis Market Drivers and Barriers

 

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