Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase II clinical trial for picankibart, an anti-IL-23p19 antibody injection, has successfully met its primary endpoint in Chinese patients with moderately to severely active ulcerative colitis (UC). The multi-center, randomized, double-blinded, placebo-controlled study (NCT05377580) evaluated the efficacy of picankibart over a 12-week induction period.
The study demonstrated that the proportion of patients achieving clinical remission was significantly greater in the picankibart 200 mg group (20.0%) and the 600 mg group (14.0%) compared to the placebo group (2.0%; p < 0.05). Furthermore, the clinical response rates were notably higher in the picankibart groups, with 54.0% and 68.0% of subjects in the 200 mg and 600 mg groups, respectively, achieving a response compared to 22.0% in the placebo group (p < 0.001). Additional measures of symptomatic and endoscopic remission, as well as histologic-endoscopic mucosal remission, were also higher in the picankibart groups than in the placebo group. The safety profile of picankibart was found to be favorable, consistent with previous studies and other IL-23 class drugs, with no new safety signals detected.
Picankibart works by specifically binding to the IL-23p19 subunit, thereby inhibiting the binding of IL-23 to cell surface receptors. This targeted approach could offer a new treatment option for patients with UC. The company’s first market filing for picankibart was accepted for review in China last month, with the initial indication for the treatment of moderate to severe plaque psoriasis.- Flcube.com
