Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that primary endpoint of 12-week induction period was met in a multicenter, randomized, double-blind, placebo-controlled phase 2 clinical study (ClinicalTrials.gov, NCT05377580) of picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, in Chinese subjects with moderately to severely active ulcerative colitis (UC).

This study aims to evaluate 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 ≥2) consisting 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. During maintenance period, subjects received subcutaneous injection of picankibart 200 mg every 4 or 8 weeks. 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 ≤1, and an endoscopic subscore of ≤1) at week 12. 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.

The primary and secondary endpoints were met:

• The proportion of subjects who achieved clinical remission was significantly higher in the picankibart 200 mg group (20.0%) and 600 mg group (14.0%) than in the placebo group (2.0%; p < 0.05).
• Clinical response was achieved in 54.0% and 68.0% of subjects in the picankibart 200 mg and 600 mg groups, respectively, which was significantly higher than in the placebo group (22.0%; p < 0.001).
• In addition, the proportion of subjects who achieved symptomatic remission, endoscopic remission, or histologic-endoscopic mucosal remission in the picankibart 200 mg and 600 mg groups than in the placebo group.

The overall safety profile of the picankibart groups was favorable and similar to that of previous studies and other IL-23 class drugs, with no new safety signals observed.

To date, the maintenance period of the study is ongoing, and the proportions of subjects who have achieved clinical remission, clinical response, symptomatic remission, endoscopic remission, or histologic-endoscopic mucosal remission have continued to increase compared to induction period. Detailed data will be further analyzed and published at future academic congresses or in clinical journals.

Professor Minhu Chen, the Principal Investigator of the Clinical Study, the First Affiliated Hospital of Sun Yat-sen University, stated, "Ulcerative colitis is a chronic, recurrent inflammatory disease involving colorectal mucosa, which is related to the interaction of genetic, environmental and immune factors. its common symptoms including abdominal pain, diarrhea, rectal bleeding, weight loss and fatigue. Current treatment approaches mainly focus on controlling inflammation, alleviating symptoms, and maintaining remission. New treatment methods are urgently needed to offer more meaningful improvements. I am pleased to see that the primary endpoint was achieved in a Phase 2 clinical study of picankibart in moderately to severely active ulcerative colitis, with significant clinical benefits in the induction period and a favorable safety profile observed. I look forward to the further development of picankibart to provide more treatment options for Chinese patients with ulcerative colitis."

Dr. Lei Qian, Senior Vice President of Clinical Development of Innovent, stated: "Ulcerative colitis, as a chronic inflammatory disease, not only damages patients' physical health, but also seriously impact their daily lives and mental health. 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 2 study is the first clinical trial in China to evaluate a domestic IL-23p19 drug candidate for the treatment of ulcerative colitis. Picankibart is independently developed by Innovent, and has its first new drug application under NMPA review for treating plaque psoriasis. The encouraging results of this Phase 2 study in patients with ulcerative colitis gave us more confidence of the clinical potential of picankibart in treating more autoimmune diseases. We truly hope to bring accessible and high-quality innovative biologics to benefit a wide range of patients."