22 Nov New Fusion Protein Drug Shows Promise in Lupus Study
MedicalResearch.com Interview with:
Professor Jianmin Fang, Ph.D.
Founder, CEO & CSO
MedicalResearch.com: What is the background for this study?
Response: Systemic lupus erythematosus (SLE), known more commonly as lupus, is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissue. SLE can affect tissues like the skin, joints, kidneys, brain and other organs, resulting in a wide variety of signs and symptoms.
With limited treatment options for lupus and the significant unmet medical needs in the treatment of autoimmune diseases, the Phase 2b study evaluated the efficacy and safety of subcutaneous RC18 (telitacicept), a potential new medicine for the treatment of systemic lupus erythematosus (SLE) versus a placebo in combination with standard therapy in patients with SLE at 48 weeks.
MedicalResearch.com: What are the main findings?
Response: The data demonstrated that the trial met its primary endpoint with a higher proportion of patients receiving RC18 in varying dosages achieving a clinically meaningful improvement in disease activity vs placebo, with both arms receiving standard of care.
The proportion of patients with clinically meaningful disease activity improvement was also statistically significant at 160 mg (68.3%, p<0.001) and 80 mg (71%, p<0.001) as compared to placebo (33.9%). Clinically meaningful disease activity improvement is achieved if a greater than four-point reduction in SRI4 occurred. RC18 240 mg, 75.8% of patients achieved clinically meaningful disease activity improvement (p<0.001), as compared to placebo (33.9%). The
The most common treatment-related adverse events included upper respiratory tract infection and injection site reactions.
MedicalResearch.com: What should readers take away from your report?
Response: Our data at the American College of Rheumatology Annual Meeting demonstrated that RC18 can safely and effectively target lupus with its dual-target mechanism for patients suffering from autoimmune diseases.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: While there is no cure for SLE and treatments that are approved currently aim to control symptoms, we look forward to continuing our research in the space to hopefully bring a new effective treatment option for people living with SLE. We will be working with regulatory authorities around the world to start global Phase 3 trials in 2020 in effort to provide treatments to patients as soon as possible.
Disclosures: This study was funded by the RemeGen, Ltd.
Wu, Speaker’s Bureau and research support from RemeGen, Ltd; J. Li, Speaker’s Bureau and research support from RemeGen; D. Xu, Research support from RemeGen, Ltd; W. Wang, Employee and equity shareholder of RemeGen, Ltd; L. Li, Employee and equity shareholder of RemeGen, Ltd; J. Fang, Employee and equity shareholder of RemeGen, Ltd; F. Zhang, Speaker’s Bureau and research support from RemeGen, Ltd
Citation: Abstract presented during the late breaking session at the at the 2019 American College of Rheumatology Annual Meeting
A Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), Telitacicept (RC18), in Systemic Lupus Erythematosus (SLE): Results of a Phase 2b Study
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