Core Viewpoint - Innovent Biologics announced that picankibart (IBI112), a recombinant anti-IL-23p19 antibody, successfully met all primary and key secondary endpoints in the Phase 3 CLEAR-1 study for moderate to severe plaque psoriasis, demonstrating significant efficacy and a favorable safety profile [1][2][5]. Group 1: Study Results - CLEAR-1 is the first global Phase 3 registration study in the IL-23p19 class, reporting over 80% of subjects achieving PASI 90 after 16 weeks of treatment [1][2]. - At week 16, 80.3% of subjects receiving picankibart achieved PASI 90 compared to 2.0% for placebo, and 93.5% achieved sPGA 0 or 1 compared to 13.1% for placebo, both with p<0.0001 [2]. - The efficacy of picankibart was maintained through week 52, with 84.9% achieving PASI 90 and 85.9% achieving sPGA 0/1 [3]. Group 2: Secondary Endpoints and Quality of Life - All key secondary endpoints were met, including improvements in PASI 75, PASI 100, sPGA scores, and Dermatology Life Quality Index (DLQI) scores, with results maintained through 52 weeks [4]. - Picankibart showed superiority over placebo in improving all measured parameters, significantly enhancing patients' quality of life [4]. Group 3: Safety Profile - The overall safety profile of picankibart was favorable, with no new safety signals identified compared to previous studies [5]. - Ongoing follow-up of the study will provide complete data for future academic presentations [5]. Group 4: Company and Product Information - Picankibart is a monoclonal antibody developed by Innovent, specifically targeting the IL-23p19 subunit, potentially offering a more effective treatment for psoriasis and other autoimmune diseases [9]. - Innovent is a leading biopharmaceutical company focused on developing high-quality biologics for various diseases, with multiple products in the market and ongoing clinical trials [10].
Innovent Announces Picankibart (IBI112) Achieved Primary Endpoints in a Phase 3 Clinical Trial in Treating Moderate to Severe Plaque Psoriasis, and Plans to Submit NDA to the NMPA