YANTAI, China, Nov. 15, 2019 /PRNewswire/ -- RemeGen, Ltd. today announced a Phase IIb clinical trial of RC18 (telitacicept), a potential new medicine for the treatment of systemic lupus erythematosus (SLE), met its primary endpoint of a greater than 4-point reduction in the SLE Responder Index (SRI4). With RC18 240 mg, 75.8% of patients achieved clinically meaningful disease activity improvement (p<0.001), as compared to placebo (33.9%). The results were shared during an oral presentation at the 2019 ACR/ARP Annual Meeting.

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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%).ⁱ The most common treatment-related adverse events included upper respiratory tract infection and injection site reactions.ⁱ Clinically meaningful disease activity improvement is achieved if a greater than four point reduction in SRI4 occurred.

"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."

Systemic lupus erythematosus (SLE) is a 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. ^iii,iv Globally, an estimated five million people live with a form of lupus.^v SLE accounts for approximately 70% of all cases of lupus.^vi 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 patients.^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."

About RC18 (telitacicept)
RC18 is a novel recombinant TACI-Fc (transmembrane activator and calcium modulator and cyclophilin ligand interactor) fusion protein that was developed to treat autoimmune diseases. RC18 has a dual-targeting mechanism that inhibits the development and survival of plasma cells and mature B cells, which are implicated in several autoimmune diseases. RC18 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. RC18 is currently being studied in several late-stage clinical trials across autoimmune diseases, including rheumatoid arthritis, multiple sclerosis and systemic lupus erythematosus.

About the Phase IIb Trial
The Phase IIb trial evaluated the efficacy and safety of RC18 (telitacicept) versus placebo in combination with standard therapy in patients with systemic lupus erythematosus (SLE) at 48 weeks. SLE patients aged 18 to 65 years with positive ANA and/or anti-dsDNA and with a SELENA-SLEDAI score ≥8 were randomized 1:1:1:1 to receive subcutaneous Telitacicept at 80 mg, 160 mg, 240 mg or placebo once a week in combination with standard therapy for 48 weeks. The primary endpoint was response rate of SLE Responder Index 4 (SRI4) at Week 48. The Phase IIb trial found that RC18 (telitacicept) was well tolerated in SLE patients.

About SLE Responder Index 4
SLE Responder Index 4 (SRI4) response is a is a composite endpoint used in SLE clinical trials that assesses disease activity and response to treatment, such as reduction in disease activity in the preceding 10 days, resolution of skin rashes, flare rate and reduction in daily oral corticosteroid dosage.ⁱⁱ Clinically meaningful disease activity improvement is achieved if a greater than 4 point reduction in SRI4 occurred. SRI4 includes criteria from three internationally validated indices, including SELENA-SLE Disease Activity Index (SELENA-SLEDAI), British Isles Lupus Assessment Group (BILAG) and Physician's Global Assessment (PGA).ⁱⁱ

About RemeGen, Ltd.
RemeGen, Ltd. is a leading biopharmaceutical company in China dedicated to fulfilling unmet medical needs for patients with life-threatening conditions. RemeGen, Ltd.'s main focus is research and development, manufacturing and commercialization of novel biologics, most notably bispecific fusion proteins, monoclonal antibodies (mAb) and antibody-drug conjugates (ADCs). Headquartered in Yantai, Shandong Province, RemeGen, Ltd. has laboratory research facilities and offices in Beijing, Shanghai and California. It has an extensive collaboration with Tongji University, one of the top universities in China. Since its inception in 2008, RemeGen, Ltd. has created more than 10 novel drug molecules that are in various stages of development. Currently, there are two products in Phase III clinical development to treat autoimmune and oncology indications: RC18 and RC48.

Forward-Looking Statements
Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the possible utility or application of the Company's technologies to develop therapeutic agents, therapeutic potential of investigational agents, and future development activities including clinical trials. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the difficulty and uncertainty of pharmaceutical product development, including the risks that RemeGen, Ltd. may experience delays in its planned clinical trial initiations or otherwise experience failures or setbacks in its preclinical and clinical development programs due to the potential lack of efficacy or risk of adverse events as RemeGen, Ltd.'s product candidates advance in development or other factors. These factors include those discussed in RemeGen, Ltd.'s public reports are available by contacting Dan Ross at danross@remegen.cn. RemeGen, Ltd. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

References

i.  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.

ii.  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.

iii.  US National Library of Medicine. Systemic lupus erythematosus. MedlinePlus. Available at https://medlineplus.gov/ency/article/000435.htm.

iv.  Calabrese 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

v.  Lupus Foundation of American. Lupus Facts and Statistics. 2019. Available at https://www.lupus.org/resources/lupus-facts-and-statistics

vi.  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.

SOURCE RemeGen, Ltd.