Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced the successful completion of a Phase III trial for its pipeline candidate drug, picankibart (IBI112). The drug, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, has met all primary and key secondary endpoints in the Phase III registrational study CLEAR-1, which was conducted in Chinese subjects with moderate to severe plaque psoriasis. The company plans to submit a new drug application (NDA) for picankibart in the treatment of psoriasis to China’s Center for Drug Evaluation (CDE) shortly.
CLEAR-1 (NCT05645627) is a multicenter, randomized, double-blind, placebo-controlled Phase III study designed 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. The co-primary endpoints were the proportion of subjects achieving ≥90% improvement from baseline Psoriasis Area and Severity Index score (PASI 90) and the proportion of subjects achieving a static Physician’s Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16. The study results indicated that the co-primary endpoints were successfully met: at week 16, a significantly higher proportion of subjects receiving picankibart achieved PASI 90 and sPGA 0 or 1 compared with placebo (80.3% vs. 2.0% for PASI 90 and 93.5% vs. 13.1% for sPGA 0/1, both p<0.0001). CLEAR-1 is the first global Phase 3 registration study in the IL-23p19 class to report over 80% of subjects achieving PASI 90 after 16 weeks of treatment in psoriasis. Picankibart demonstrated a favorable safety profile with no new safety signals.
Picankibart (IBI112) is a monoclonal antibody independently developed by Innovent, holding independent intellectual property rights. This product specifically binds to the IL-23p19 subunit, thereby preventing IL-23 from binding to cell surface receptors. Picankibart may offer a more effective treatment option for patients with psoriasis or other autoimmune diseases.- Flcube.com
