Rheumatoid Arthritis - Pipeline Insight, 2024

Rheumatoid Arthritis - Pipeline Insight, 2024

DelveInsight’s, “Rheumatoid Arthritis - Pipeline Insight, 2024” report provides comprehensive insights about 95+ companies and 100+ pipeline drugs in Rheumatoid Arthritis pipeline landscape. It covers the pipeline drug profiles, including clinical 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.

Geography Covered

• Global coverage

Rheumatoid Arthritis: Understanding

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.

Most of the signs and symptoms of RA are vague and reoccur every time after departing. Few symptoms could be evident enough in the early stages for a person to go for the confirmatory diagnosis. Still, the symptoms in the initial days overlap with several other normal health-related issues. Due to which a person does not move forward with the diagnostic procedure.

Clinically, RA patients typically present with a recent onset of tender and swollen joints, morning joint stiffness, generalized sickness symptoms. Timely and precise diagnosis is of high importance in RA treatment since early diagnosis can arrest irreparable joint damage and disability in up to 90% of RA patient’s disease in many patients, thereby preventing or substantially slowing disease progression. Typically, RA is diagnosed by a combination of patient’s symptoms, results of doctor´s examination, assessment of risk factors, family history, a joint assessment by ultrasound sonography, and assessment of laboratory markers such as elevated levels of CRP and ESR in serum and detection of RA-specific autoantibodies.

DMARDs are a group of drugs that have been shown to affect the underlying cause of RA by damping down the over-activity of the immune system, which helps ease pain, swelling, and stiffness, and prevent changes occurring within the joint. JAK inhibitors are a new type of medicine available for adults with severe rheumatoid arthritis. Advances in chemical engineering have made it possible to produce these called ‘small molecule’ drugs—chemicals that are highly specific for blocking molecules that have been identified within cells that cause chronic inflammation. To date, the US FDA has approved three JAK inhibitors for the treatment of RA. These are: Tofacitinib (Xeljanz), Baricitinib (Olumiant), Upadacitinib (Rinvoq).

“Rheumatoid Arthritis - Pipeline Insight, 2024"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Rheumatoid Arthritis pipeline landscape is provided which includes the disease overview and Rheumatoid Arthritis treatment guidelines. The assessment part of the report embraces, in depth Rheumatoid Arthritis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Rheumatoid Arthritis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Rheumatoid Arthritis R&D. The therapies under development are focused on novel approaches to treat/improve Rheumatoid Arthritis.

Rheumatoid Arthritis Emerging Drugs Chapters

This segment of the Rheumatoid Arthritis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Rheumatoid Arthritis Emerging Drugs

• 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.

Further product details are provided in the report……..

Rheumatoid Arthritis: Therapeutic Assessment

This segment of the report provides insights about the different Rheumatoid Arthritis drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Rheumatoid Arthritis

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.

Phases

DelveInsight’s report covers around 100+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Rheumatoid Arthritis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal
• Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Rheumatoid Arthritis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Rheumatoid Arthritis therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Rheumatoid Arthritis drugs.

Rheumatoid Arthritis Report Insights

• Rheumatoid Arthritis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Rheumatoid Arthritis Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Rheumatoid Arthritis drugs?
• How many Rheumatoid Arthritis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Rheumatoid Arthritis?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Rheumatoid Arthritis 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 Rheumatoid Arthritis and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Yuyu Pharma, Inc.
• Worg Pharmaceuticals
• Vyne Therapeutics
• Vaccinex Inc.
• Tiziana Life Sciences
• Teijin Pharma
• Taiho Pharmaceutical
• Synermore Biologics Co., Ltd.
• Synact Pharma
• Sorrento Therapeutics
• Sonoma Biotherapeutics
• SinoMab Bioscience Ltd
• Silo Pharma
• SFA Therapeutics
• Servatus Biopharmaceuticals
• SciRhom
• R-Pharm
• Rottapharm Biotech
• ROS Therapeutics
• RheumaGen
• Revolo Biotherapeutics
• RemeGen
• Regen BioPharma Inc.
• PrecisionLife
• Philogen
• Pfizer
• Oryn Therapeutics
• Nurix
• NovImmune
• Novartis
• Neutrolis Therapeutics
• MyMD Pharmaceuticals
• Modern Biosciences
• Minghui Pharmaceutical Pty Ltd
• MetrioPharm
• Mesoblast
• Lysatpharma GmbH
• Lynk Pharmaceuticals
• Landos Biopharma
• Kymera Therapeutics
• Kolon TissueGene
• KLUS Pharma
• Kiniksa Pharmaceuticals, Ltd.
• Kangstem Biotech
• Jubilant Therapeutics
• Jiangsu Hengrui Medicine
• Janssen Research & Development
• Intrinsic Medicine
• Innocare Pharma Australia Pty Ltd
• Immutep Limited
• Imcyse
• I-Mab Biopharma Co. Ltd.
• Iltoo Pharma
• IGM Biosciences, Inc.
• ICMBIO
• Ichnos Sciences
• Hutchison MediPharma
• Horizon Therapeutics plc
• Hope Biosciences
• Hanlim Pharm
• Gilead Sciences
• Genosco
• Galmed Pharmaceuticals
• Galapagos NV
• Fresh Tracks Therapeutics, Inc.
• Fountain Biopharma Inc.
• f5 Therapeutics
• Evelo Biosciences
• Endpoint Health
• Eli Lilly and Company
• Draconis Pharma
• Cyxone
• CV6 Therapeutics
• Chong Kun Dang Pharmaceutical
• Celltex Therapeutics
• Carna Biosciences
• Cabaletta Bio
• BTB Pharma
• Bristol-Myers Squibb
• Boryung Pharmaceutical Co., Ltd
• Biozeus
• Beijing Baylx Biotech
• Bayer
• Bagi Biosciences
• AstraZeneca
• Arthrogen
• Applied Molecular Transport

Key Products

• YY-3411
• Research programme
• VYN 201
• VX5/5261
• Foralumab
• TCK 276
• TAS5315
• SYN060
• AP1189
• Sofusa anti-TNF
• SBT 77 7101
• SM03
• SPU-21
• SFA002
• SVT 6A4710
• Research programme: anti-iRhom2 monoclonal antibodies
• Olokizumab
• CR 6086
• Trexior
• Research Programme: HLA Gene-Editing
• IRL 201805
• RC18
• Research Programme: small molecule
• Research programme: Rheumatoid arthritis
• Dekavil
• PF-06651600/ PF-6650833/ tofacitinib
• PF-06650833
• PF-06835375
• ORTD-1
• NX-5948
• NI-0101
• VAY736
• CFZ-533
• NTR-441
• MYMD-1
• MBS2320
• MH004
• MP 1032
• MPC-300-IV
• LPRA-01
• LNK01001
• LABP-104
• LABP-69
• KT-474
• Invossa
• A223
• KPL-404
• FURESTEM-RA
• JBI-1044
• SHR0302
• Nipocalimab
• JNJ-4703
• OM001
• ICP-022
• IMP 761
• Research programme: rheumatoid arthritis therapeutics
• TJ003234
• Interleukin 2
• IgM Antibodies
• ICM-203-R
• ISB-830
• HMPL-523
• Dazodalibep
• HB-adMSC
• HL237
• GS-5718
• SKI-O-703
• Amilo 5MER
• GLPG3970
• '4399
• FRTX-02
• FB704A
• Research programme: Autoimmune disorder therapeutics
• EDP1815
• EP004
• LY3462817
• Research Programme: EP4 Program receptor antagonist
• Rabeximod
• CV6 1271
• CKD-506
• CKD-374
• Autologous Adipose-derived Stem Cells
• AS 0871
• CABA-201
• BTB003
• Varicella Zoster Vaccine
• Nivolumab