InnoCare Pharma Limited (9969.HK), a biopharmaceutical company, announced on Tuesday enrollment of the first patient in the Phase 3 clinical trial evaluating Orelabrutinib in treating systemic lupus erythematosus.
Systemic lupus erythematosus (SLE) is a systemic autoimmune disease that leads to multi-organ damage, affecting the kidneys, musculoskeletal system, nervous system, blood, and respiratory system of the patient. There are an estimated 8 million people, mostly young and middle-aged women, living with SLE worldwide.
Orelabrutinib is a novel, BTK-inhibitor developed to treat varied inflammatory indications. It is the first BTK inhibitor to show significant efficacy in a Phase 2 trial for SLE. In the Phase 2b trial, orelabrutinib successfully met the primary endpoint, achieving statistically significant improvement in SLE Response Index-4 (SRI-4) at week 48. Patients in the testing cohort also demonstrated a decrease of steroid use when compared to those on a placebo.
The ongoing Phase 3 trial is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of orelabrutinib. The primary endpoint is established as the SRI-4 response rate measured at week 52.
9969.HK is trading on the Hong Kong stock exchange, and closed Tuesday at HK$ 13.72, down 2.35%.
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