By Fineline Cube China-based Innovent Biologics Inc. (HKG: 1801) announced that its interleukin-23 subunit p19 (IL-23p19) monoclonal antibody (mAb) IBI-112 (picankibart) has achieved primary endpoints in a Phase II clinical trial in China for moderate-to-severe plaque psoriasis. The multi-center, randomized, double-blind, placebo-controlled Phase II study (CIBI112A201; clinicaltrials.gov: NCT 05003531) enrolled 250 subjects randomized into five dosage regimen groups versus placebo. The study lasted 52 weeks, with picankibart achieving the primary endpoint of the proportion of subjects achieving a ≥90% improvement in the Psoriasis Area and Severity Index (PASI) at week 16 (PASI90). To date, a total of 245 subjects (98.0%) met the 16-week requirement, while 236 subjects (94.4%) remained qualified at the 28-week stage.
Safety and Efficacy
In terms of safety, picankibart was generally well-tolerated, with no new safety signals identified compared to previous clinical studies. The overall safety profile is similar to other IL-23p19 mAbs. The most frequently reported (incidence ≥10%) treatment-term adverse event was upper respiratory tract infection, with mild-to-moderate severity.
Mechanism of Action
IBI-112 specifically binds to IL-23p19 to block the IL-23-mediated signaling pathways, thereby exerting an anti-inflammatory effect. Preclinical studies demonstrated that IBI-112 has a clear target, a clear mechanism of action, and a significant anti-inflammatory effect. The results of this clinical study show that 50 to 200 mg of picankibart administered every 12 weeks or 8 weeks can significantly improve skin lesions and the quality of life of subjects with moderate-to-severe plaque psoriasis. The drug can be administered long-term with significant efficacy at these intervals. Picankibart is expected to provide more effective treatment options for patients with psoriasis and other autoimmune diseases.-Fineline Info & Tech