Clinical Trial Results Promising for People with Lupus

2019-11-27T08:07:00

(BPT) – Systemic lupus erythematosus (SLE) is a mysterious chronic autoimmune disease in which the immune system mistakenly attacks healthy tissue.^iii,iv SLE can affect tissues like the skin, joints, kidneys, brain and other organs, resulting in a wide variety of signs and symptoms that impact the daily lives of those with the disease.^iii,iv Globally, an estimated 5 million people live with a form of lupus^v and SLE accounts for approximately 70% of all cases of lupus.^v Now, the results from a clinical trial are providing hope to people living with SLE.

RemeGen, Ltd., a leading biopharmaceutical company in China, recently announced a Phase IIb clinical trial of RC18 (telitacicept), a potential new medicine for the treatment of SLE, met its primary endpoint of a greater than 4-point reduction in the SLE Responder Index (SRI4).ⁱ With RC18 240 mg, 75.8% of patients achieved clinically meaningful disease activity improvement (p<0.001), as compared to placebo (33.9%).ⁱ The results were shared during an oral presentation at the 2019 ACR/ARP Annual Meeting.

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.ⁱ

“We are very pleased with the fact that over 70% of patients who were treated with RC18 showed clinically meaningful benefit in this trial,” said Dr. Wu, lead investigator of the trial. “This is the latest chapter in the very promising treatment story of RC18, and we are excited about making this treatment a reality and available to the many who are impacted by lupus daily.”

Keep in mind, there is no cure for SLE and the goal of currently available treatments is to control symptoms.ⁱⁱⁱ Only one drug was approved by the FDA for SLE in the last 60 years, despite urgent unmet medical needs for those with live with the disease daily.^v However, managing SLE continues to be complicated and mortality rates remain a major concern.^iv

“Characterized by complicated, debilitating symptoms and frustrated by a lack of effective treatment options, lupus continues to disrupt the lives of patients and challenge physicians,” said Jianmin Fang, Ph.D., founder and CEO of RemeGen, Ltd. “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.”

RemeGen looks forward to continuing research in the space to bring a new treatment alternative for people living with SLE to a desolate treatment landscape. The company will be working with regulatory authorities around the world to start Phase 3 trials in 2020 in effort to provide treatments to patients as soon as possible. If you’re interested in learning more about RC18, visit RemeGen.com.

References

1. Wu 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.
2. Luijten KM, Tekstra J, Biljsma JW, et al. The systemic lupus erythematosus responder index (SRI); a new SLE disease activity assessment. Autoimmun Rev. 2012;11(5):326-9. doi: 10.1016/j.autrev.2011.06.011. Epub 2011 Sep 18. Available at https://www.ncbi.nlm.nih.gov/pubmed/21958603.
3. US National Library of Medicine. Systemic lupus erythematosus. MedlinePlus. Available at https://medlineplus.gov/ency/article/000435.htm.
4. Lupus Foundation of American. Lupus Facts and Statistics. 2019. Available at https://www.lupus.org/resources/lupus-facts-and-statistics
5. Pons-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.