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YANTAI, China, July 25, 2023 /PRNewswire/ -- RemeGen Co., Ltd. ("RemeGen" or "the Company") (HKG: 9995, SHA: 688331), a fully-integrated commercial-stage biotechnology company, has announced that their Phase II clinical study of telitacicept (RC18) for the treatment of Primary Sjögren's Syndrome (pSS) in adults has been published in top international medical journal Rheumatology.
Rheumatology is the official journal of the British Society for Rheumatology which is published by Oxford University Press. The journal is currently included in 27 international databases and is a top journal in this field with an impact factor of 7.046 in 2021.
The study, led by Professor Zeng Xiaofeng from the Department of Rheumatology and Immunology in Peking Union Medical College Hospital, was a randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of telitacicept in treating adult pSS patients.
A total of 42 subjects were included, with three groups randomly receiving subcutaneous injections of placebo, 160mg of telitacicept, and 240mg of telitacicept once a week for 24 weeks. The study found significant improvements in EULAR Sjögren's syndrome (SS) disease activity index (ESSDAI) scores, with mean changes from a baseline of 0.6 ± 4.55, -3.3 ± 2.73, and -1.3 ± 4.14 in the placebo, 160mg, and 240mg groups, respectively. Using mixed model for repeated measures (MMRM), the change in ESSDAI was significantly lower compared to placebo for the 160mg group at week 24 (P value=0.002). Telitacicept treatment was well-tolerated, with no deaths or serious adverse events reported. The drug demonstrated promising clinical benefits, improving ESSDAI scores, MFI-20, and reducing immunoglobulin levels. Overall, telitacicept showed great potential as a breakthrough treatment for pSS.
"RemeGen is delighted with these published breakthrough findings that offer new hope for pSS treatment. As a new drug with significant potential, telitacicept Phase II clinical study data has been published in top international journals, which is major proof of our research and development capabilities. We fully expect telitacicept to enter the market imminently, bringing much-needed new hope to patients all over the world," said Dr. Jianmin Fang, CEO and Chief Scientific Officer of RemeGen.
pSS is an autoimmune disorder primarily affecting the mucous membranes and moisture-secreting glands, causing diminished tear and saliva production, resulting in dry mouth and eyes. Secondary Sjögren's syndrome is characterized by accompanying autoimmune diseases such as rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). pSS involves highly active B cells, with B cell pathways playing a crucial role in its development. Currently, there is no satisfactory evidence-based treatment for pSS, and existing drugs are often empirical or based on similar conditions. Telitacicept, a novel fully human TACI-Fc fusion protein, shows promise in inhibiting B cell maturation and reducing autoantibody production, offering significant potential disease activity control.
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: www.remegen.cn
About Telitacicept (RC18)
Telitacicept (RC18, Brand Name: 泰爱®) is a proprietary novel fusion protein from RemeGen to treat 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-cell 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. It was granted conditional marketing approval by China's National Medical Products Administration (NMPA) to treat systemic lupus erythematosus (SLE) in March 2021.