Innovent Announces Phase 2 Clinical Study of Picankibart (IBI112) in Chinese Patients with Ulcerative Colitis Met Primary Endpoint

Clinical Study Results - The primary endpoint of the 12-week induction period was met in a Phase 2 clinical study of picankibart (IBI112) for treating moderately to severely active ulcerative colitis (UC) in Chinese subjects [1] - The study enrolled 150 subjects randomized to receive placebo, picankibart 200 mg, or picankibart 600 mg during the induction period [2] - Clinical remission rates at week 12 were 20.0% for the 200 mg group and 14.0% for the 600 mg group, significantly higher than the 2.0% in the placebo group (p < 0.05) [3] - Clinical response rates were 54.0% for the 200 mg group and 68.0% for the 600 mg group, significantly higher than the 22.0% in the placebo group (p < 0.001) [3] - The maintenance period is ongoing, with continued increases in clinical remission, response, and other efficacy measures compared to the induction period [4] Picankibart (IBI112) Development - Picankibart is a recombinant anti-IL-23p19 antibody injection developed by Innovent [1] - It has shown potential for treating psoriasis, ulcerative colitis, and other autoimmune diseases [7] - Multiple clinical studies are underway, including Phase 3 studies for plaque psoriasis and Phase 2 studies for UC [7] - The NMPA accepted the first NDA for picankibart for treating moderate to severe plaque psoriasis in September 2024 [8] Ulcerative Colitis Market - UC is a chronic inflammatory disease with increasing prevalence in China, currently at 11.6/100,000 [6] - Current treatments include traditional immunosuppressants and biologics, but there are unmet needs due to adverse reactions and loss of response [6] - No IL-23p19 targeted drugs are approved for UC treatment in China, representing a significant market opportunity [6] Innovent Biologics Overview - Innovent is a leading biopharmaceutical company founded in 2011, focusing on oncology, autoimmune, cardiovascular, metabolic, and ophthalmology diseases [9] - The company has launched 11 products, with 5 NDAs under regulatory review and 3 assets in Phase III or pivotal trials [9] - Innovent has partnerships with over 30 global healthcare companies, including Eli Lilly, Sanofi, and Incyte [9]