Telitacicept

UCB and Biogen reported encouraging topline findings from the Phase III PHOENYCS GO trial, which assessed dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in individuals with moderate-to-severe SLE. The promising outcomes with dapirolizumab pegol signify significant advancements in creating treatments that can enhance the quality of life for individuals with lupus, a condition that continues to have considerable unmet medical needs, particularly impacting women. LAS VEGAS, Oct. 7, 2024 /PRNewswire/ -- Systemic lupus erythematosus is a long-lasting autoimmune disorder that can impact various areas of the body. Lupus arises when the immune system, typically responsible for defending against infections and illnesses, mistakenly targets the body's own tissues. This misguided response leads to inflammation and, in some instances, lasting damage to tissues, potentially affecting a wide range of organs including the skin, joints, heart, lungs, kidneys, blood cells, and brain. As per the estimates, the prevalence of systemic lupus erythematosus in the United States is approximately 500K cases in 2023. In females, prevalence rates are observed to be much greater than that of males, constituting more than 90% of the total prevalent cases in the US. In 2023, among the treated SLE patients, nearly 40% of patients became relapsed or refractory after the first line of therapy. The main goals of SLE treatment are to alleviate symptoms, prevent or reduce organ damage and disease flare-ups, minimize drug toxicity, and improve the patient's overall quality of life. The SLE treatment plan primarily includes antimalarial medications (like hydroxychloroquine), glucocorticoids (such as prednisone or similar), immunosuppressive drugs (including methotrexate, azathioprine, or mycophenolate), and biologics, in addition to nonsteroidal anti-inflammatory drugs (NSAIDs) for managing inflammation and pain. Biologics are specifically used for patients who do not respond to standard treatments or for those with severe, organ-threatening diseases. Currently, the biologics approved by the US FDA as adjunct therapies for SLE patients are BENLYSTA and SAPHNELO. In contrast, the use of rituximab for treating SLE is considered off-label. Learn more about the FDA-approved SLE drugs @ Drugs for Systemic Lupus Erythematosus Treatment BENLYSTA (belimumab) is a fully human monoclonal antibody that targets and inhibits BLyS (B-lymphocyte stimulator), a protein found at elevated levels in patients with systemic autoimmune diseases such as systemic lupus erythematosus and lupus nephritis. By binding to soluble BLyS, BENLYSTA prevents the prolonged survival of B cells, including autoreactive B cells, and reduces their differentiation into plasma cells that produce immunoglobulins. However, BENLYSTA does not directly bind to B cells. First approved by the US FDA in 2011, it is the only biologic therapy approved for the treatment of active SLE and LN in more than 50 years, including for pediatric patients. SAPHNELO (anifrolumab) is a fully human monoclonal antibody and the first of its kind, targeting subunit 1 of the type I interferon (IFN) receptor to inhibit type I IFN activity. Type I IFNs, including IFN-alpha, IFN-beta, and IFN-kappa, are cytokines that play a role in the inflammatory pathways associated with systemic lupus erythematosus. Most adults with SLE exhibit increased type I IFN signaling, which correlates with greater disease activity and severity. SAPHNELO has been approved for the treatment of SLE in over 60 countries, including the US, EU, and Japan, with ongoing reviews in additional regions. To know more about SLE treatment options, visit @ New Treatment for Systemic Lupus Erythematosus SLE pipeline possesses some drugs in mid and late-stage developments to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including Litifilimab (Biogen), Ianalumab (Novartis), Cenerimod (Idorsia/Viatris), Dapirolizumab pegol (UCB/Biogen), Telitacicept (RC18) (RemeGen), and others in different lines of treatment. The expected launch of these therapies shall further create a positive impact on the market. Discover which therapies are expected to grab major SLE market share @ Systemic Lupus Erythematosus Market Report Dapirolizumab pegol is a novel investigational treatment, consisting of a humanized, Fc-free antigen-binding (Fab') fragment conjugated with polyethylene glycol (PEG). It works by inhibiting CD40L signaling, which has been shown to reduce B cell activation, decrease autoantibody production, limit type 1 interferon (IFN) secretion, and suppress the activation of T cells and antigen-presenting cells (APCs). In September 2024, UCB and Biogen announced that the Phase III PHOENYCS GO trial achieved its primary goal, showing clinical improvements in patients with moderate-to-severe systemic lupus erythematosus. Additionally, key secondary endpoints, assessing disease activity and flare-ups, also demonstrated clinical improvements. Following the positive results from the PHOENYCS GO study, UCB and Biogen are launching a second Phase 3 trial of dapirolizumab pegol in 2024, named PHOENYCS FLY. Participants from the PHOENYCS GO study will continue to be monitored in a long-term open-label extension. Biogen is working on developing Litifilimab (BIIB059), an experimental humanized monoclonal antibody. This antibody specifically targets and binds to blood dendritic cell antigen 2 (BDCA2), a receptor found on plasmacytoid dendritic cells (pDCs). When BDCA2 is engaged, it inhibits the production of type I interferons (IFN-I) and other inflammatory molecules. BDCA2 is exclusively expressed on the surface of human pDCs. Litifilimab acts as an inhibitor of B-cell lymphocyte stimulator. Currently, Biogen is conducting Phase III clinical trials to evaluate its use for treating SLE. Ianalumab, developed by Novartis, is an antibody aimed at the B-cell activating factor receptor (BAFF-R). It is designed to inhibit BAFF-R signaling and deplete B cells through antibody-dependent cellular cytotoxicity. The drug is currently undergoing a Phase III clinical trial for systemic lupus erythematosus, with the company expecting to submit it for approval by 2027, according to a recent presentation. Cenerimod is an oral, once-daily tablet that acts as a highly selective modulator of the sphingosine-1-phosphate receptor 1 (S1P1). Although the exact cause of systemic lupus erythematosus is not fully understood, T and B lymphocytes are believed to be the primary immune cells involved in the disease's progression. These cells express the S1P1 receptor on their surface. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Discover more about drugs for SLE in development @ Systemic Lupus Erythematosus Clinical Trials The anticipated launch of these emerging therapies for SLE are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the SLE market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for SLE is expected to grow from USD 3.2 billion in 2023 with a significant CAGR by 2034. This growth is mainly driven by ongoing clinical research and better diagnostic tools that might improve the prognosis of the disease. DelveInsight's latest published market report titled as Systemic Lupus Erythematosus Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the SLE country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The SLE market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total SLE Diagnosed Prevalent Cases Total SLE Diagnosed Prevalent Cases by Gender Total SLE Diagnosed Prevalent Cases by Age SLE Severity-Based Diagnosed Prevalent Cases Total SLE Treated Cases The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM SLE market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this SLE market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the SLE market. Also, stay abreast of the mitigating factors to improve your market position in the SLE therapeutic space. Related Reports Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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YANTAI, China, Aug. 6, 2024 /PRNewswire/ -- RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, SHA:688331), a commercial-stage biotechnology company, announced that the company's self-developed BLyS/APRIL dual targeting fusion protein innovative drug telitacicept has achieved the first patient enrollment in the United States for its global multi-center phase III clinical trial for the treatment of generalized myasthenia gravis (gMG). This milestone marks an important step in the worldwide clinical development of telitacicept, which will bring new hope to myasthenia gravis patients globally. Previously, telitacicept was granted orphan drug and fast track status for myasthenia gravis indication by the US Food and Drug Administration (FDA) and breakthrough therapy designation by the National Medical Products Administration (NMPA) of China. This global, multicenter, randomized, double-blind, placebo-controlled, phase III study aims to evaluate the efficacy and safety of telitacicept in the treatment of gMG. The trial plans to recruit 180 patients from multiple countries and regions around the world. Myasthenia gravis (MG) is a rare, chronic autoimmune disease that leads to impaired transmission at neuromuscular junctions, which can affect eye movement, swallowing, speech, general movement and respiratory function at varying degrees. According to the Frost & Sullivan report, the global number of myasthenia gravis patients is expected to reach 1.15 million in 2025, with about 70,000 in the United States and 22,000 in China. At present, the main treatment methods for myasthenia gravis include cholinesterase inhibitors, glucocorticoids and immunosuppressants. However, a substantial unmet medical need remains as there are many patients can not be effectively treated due to lack of efficacy, tolerability or contraindications of existing therapies. Telitacicept is a dual targeting antibody fusion protein that targets BLyS and APRIL at the same time, and directly attack the source of pathogenic antibodies -- B cells and plasma cells, thereby reducing the production of pathogenic antibodies and achieving its therapeutic purpose. Preliminary clinical studies have shown that telitacicept can continuously and effectively improve the clinical status of patients with generalized myasthenia gravis. Since its approval in China in March 2021, telitacicept has benefited more than 40,000 patients with excellent efficacy and safety. In China, in addition to the two approved indications of systemic lupus erythematosus and rheumatoid arthritis, telitacicept has the potential to be approved for myasthenia gravis, Sjogren's syndrome, IgA nephritis, and neuromyelitis optica in the coming years. About RemeGen Co. Ltd. Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughout China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. For more details, please visit: About Telitacicept (RC18) Telitacicept (RC18) is RemeGen's proprietary novel fusion protein for the treatments of autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G(IgG). Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases. SOURCE RemeGen Co., Ltd