Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has reportedly submitted a market approval filing to the Center for Drug Evaluation (CDE) for its investigational drug picankibart (IBI112), intended for the treatment of moderate to severe plaque psoriasis.
Picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, works by specifically binding to the IL-23p19 subunit, thereby inhibiting IL-23 from binding to cell surface receptors. This targeted action may offer a more effective treatment option for patients suffering from psoriasis or other autoimmune diseases.
The Phase III CLEAR-1 study achieved all primary and key secondary endpoints in May 2024, with 500 subjects enrolled. Participants were randomized in a 1:2:2 ratio to receive placebo or picankibart 200 mg every 4 weeks at weeks 0, 4, and 8, followed by 200 mg or 100 mg every 12 weeks. The results demonstrated that at week 16, a significantly higher proportion of subjects treated with 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). Notably, CLEAR-1 is the first global Phase 3 registration study in the IL-23p19 class to report over 80% of subjects achieved PASI 90 after 16 weeks of treatment. The efficacy was sustained, with PASI 90 response rate and sPGA 0/1 response rate at 84.9% and 85.9%, respectively, at 52 weeks.- Flcube.com
