Innovent Biologics has reported that its Phase II clinical trial of picankibart (IBI112) in Chinese patients with moderately to severely active ulcerative colitis met the primary endpoint of a 12-week induction period.
The study is designed to evaluate the efficacy and safety of the anti-interleukin 23p19 subunit (IL-23p19) antibody injection.
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Ulcerative colitis, a chronic inflammatory disease affecting the colon and rectum, poses a significant threat to patients’ physical health.
Picankibart, a monoclonal antibody developed by Innovent, targets the IL-23p19 subunit and has shown potential as an effective treatment option for patients with ulcerative colitis, psoriasis and other autoimmune diseases.
The randomised, multicentre, double-blind, placebo-controlled trial enrolled 150 subjects, who were assigned to receive either an intravenous infusion of placebo or picankibart at doses of 200mg or 600mg.
The primary endpoint was clinical remission at week 12, with secondary endpoints including clinical response and endoscopic remission.
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By GlobalDataInnovent Clinical Development senior vice-president Dr Lei Qian said: “In recent years, a new generation of IL-23-targeted agents has been proven to have superior efficacy and safety for treating ulcerative colitis.
“Currently, no IL-23p19 targeted drugs were approved for the treatment of ulcerative colitis in China, and this Phase II study is the first clinical trial in China to evaluate a domestic IL-23p19 drug candidate for the treatment of ulcerative colitis.”
Significantly more subjects in the picankibart groups achieved clinical remission compared with the placebo group, with 20% in the 200mg group and 14% in the 600mg group versus 2% in the placebo group.
Clinical response rates were also higher in the picankibart groups, with 54% and 68% for the 200mg and 600mg doses, respectively, compared with 22% in the placebo group.
The safety profile of the antibody was found to be favourable and consistent with previous studies and other drugs in the IL-23 class, with no new safety concerns identified.
The trial’s maintenance period is ongoing, and results continue to show an increase in the proportion of subjects achieving clinical remission and response.
In March, Innovent dosed the first patient in a first-in-human Phase I trial of IBI3002 for the treatment of asthma.
