Chinese biopharmaceutical company Innovent Biologics Inc (HKEX: 01801) announced on Wednesday that a phase 2 clinical study of picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, has met its primary endpoint in Chinese patients with moderately to severely active ulcerative colitis (UC).

The multicentre, randomised, double-blind, placebo-controlled study aims to assess the efficacy and safety of picankibart for the treatment of moderately to severely active ulcerative colitis (modified Mayo score of 4 to 9 with an endoscopic subscore of greater than or equal to 2) comprising of induction and maintenance periods.

A total of 150 subjects were enrolled and randomized in a 1:1:1 ratio to receive intravenous infusion of placebo, picankibart 200 mg or picankibart 600 mg at weeks 0, 4 and 8 during the induction period. In the maintenance period, subjects received subcutaneous injection of picankibart 200 mg every 4 or 8 weeks.

Both the primary and secondary endpoints of the study were met. The primary endpoint was the proportion of subjects who achieved clinical remission (per modified Mayo score, defined as a rectal bleeding subscore of 0, a stool frequency subscore of less than or equal to 1, and an endoscopic sub-score of less than or equal to 1) at week 12 while secondary endpoints included the proportion of subjects who achieved clinical response, symptomatic remission, endoscopic remission or histologic-endoscopic mucosal remission compared to the placebo group.