( MENAFN - PR Newswire) SAN FRANCISCO and SUZHOU, China, May 27, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that picankibart (R & D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, has met all the primary endpoints and key secondary endpoints in the Phase 3 registrational study (CLEAR-1) in Chinese subjects with moderate to severe plaque psoriasis. CLEAR-1 is global the first Phase 3 registration study in IL-23p19 class that reported over 80% of subjects achieved PASI 90 after 16 weeks of treatment in psoriasis patients.
Innovent plans to submit a new drug application (NDA) for picankibart in the treatment of psoriasis to the Center for Drug Evaluation (CDE) of National Medical Product Administration (NMPA). Dosing interval set to 12 weeks CLEAR-1 (NCT05645627) is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of picankibart in subjects with moderate to severe plaque psoriasis. A total of 500 subjects were enrolled and randomized in a 1: 2: 2 ratio to receive placebo or picankibart 200 mg every 4 weeks at week 0, 4 and 8 followed by 200 mg or 100 mg every 12 weeks.
Co-primary endpoints were the proportion of subjects achieving ≥ 90% improvem.
