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 trials 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
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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.
Recent Developmental Activities in the Rheumatoid Arthritis Treatment
For further information, refer to the detailed Rheumatoid Arthritis Unmet Needs, Rheumatoid Arthritis Market Drivers, and Rheumatoid Arthritis Market Barriers, click here for Rheumatoid Arthritis Ongoing Clinical Trial Analysis
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.
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Scope of the Rheumatoid Arthritis Pipeline Report
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Table of Content
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