With limited treatment options currently available for patients diagnosed with systemic lupus erythematosus (SLE), known more commonly as lupus — a chronic autoimmune disease1 — a potential new medicine could be a game-changer for patients suffering from the frustrating and debilitating symptoms of lupus.
The immune system of a patient with a chronic immune disease cannot distinguish between healthy tissue and foreign invaders and produces antibodies to attack the body’s own tissue instead of fighting infection, leading to systemic inflammation in tissues and organs across the body.1,2 As a result, lupus can affect the skin, joints, kidneys, brain, and other organs, resulting in a wide variety of signs and symptoms.1,2 SLE accounts for approximately 70% of all cases of lupus,3 which can be difficult to diagnose as its symptoms mimic many other diseases and can change over the course of time.4
There is currently no cure for lupus1 and treatments that are approved currently aim to control symptoms. In fact, only one drug for SLE has been approved by the FDA in the last 60 years.5 RemeGen, Ltd., a leading biopharmaceutical company in China, recently announced positive data from a Phase 2b study for the treatment of lupus, pointing to a new wave of hope for those struggling with the disease.
RemeGen’s investigational candidate RC18 (telitacicept) is a novel recombinant TACI-Fc (transmembrane activator and calcium modulator and cyclophilin ligand interactor) fusion protein that has the potential to address significant unmet medical needs in the treatment of autoimmune diseases.
RC18 (telitacicept) is a dual-targeting fusion antibody that works by binding to two cell-signaling molecules, B lymphocyte stimulator (BLyS), and a proliferation-inducing ligand (APRIL). By only affecting mature B cells, RC18 has minimal impact on early and memory B cells, which are important for normal body immune function.6
Recent data presented at the American College of Rheumatology’s Annual Meeting unveiled positive results confirming the Phase 2b clinical trial met its primary endpoint of a greater than 4-point reduction in the SLE Responder Index (SRI4). At a dosage of RC18 240 mg, 75.8% of patients achieved clinically meaningful disease activity improvement (p<0.001), as compared to placebo (33.9%).6
“These data show the promise of RC18 to precisely target lupus with its novel dual-target mechanism and become a first-in-class and best-in-class treatment,” said Jianmin Fang, Ph.D., founder and CEO of RemeGen, Ltd. “We are excited about the potential this medicine has to effectively treat symptoms of lupus — especially in those patients who are currently struggling to manage them.”
The SLE treatment landscape is desolate — clinical trials focusing on the condition have faced many difficulties and the need for an effective treatment option is paramount. RemeGen looks forward to continuing research in the space to bring a new efficient treatment alternative for people living with SLE. The company will be working with regulatory authorities around the world to start Phase 3 trials in 2020 in an effort to provide treatments to patients as soon as possible.
Visit RemeGen.com to learn more about RC18.
1US National Library of Medicine. Systemic lupus erythematosus. MedlinePlus. Available at https://medlineplus.gov/ency/article/000435.htm.
2Calabrese LH. Treatment of SLE: bridging the gap from clinical trials to the clinic – a meeting report. Arthritis Research & Therapy. 2013;15. Available at https://arthritis-research.biomedcentral.com/articles/10.1186/ar4219
3Pons-Estel GJ, Alarcón GS, Scofield L, et al. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rhuem. 2010;39(4):257-68. doi: 10.1016/j.semarthrit.2008.10.007. Epub 2009 Jan 10.
4Lupus Foundation of America. Common Symptoms of Lupus. 2019. Available at https://www.lupus.org/resources/common-symptoms-of-lupus
5Mahieu MA, Strand V, Simon LS, et al. A critical review of clinical trials in systemic lupus erythematosus. Lupus. 2016;25(10):1122-1140. DOI: 10.1177/0961203316652492.
6Wu D, Li J, Xu D, et al. 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. Abstract. 2019 American College of Rheumatology Annual Meeting.