Innovent's Picankibart Phase 2 Study in Chinese Ulcerative Colitis Patients Meets Primary Endpoint

SAN FRANCISCO and SUZHOU, China, Oct. 16, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a biopharmaceutical company that specializes in developing, manufacturing, and commercializing medicines for oncology, autoimmune, cardiovascular, metabolic, and ophthalmic diseases, announced that they achieved the primary endpoint during the 12-week induction period in a phase 2 clinical study of picankibart. This study targeted Chinese patients with moderate to severe ulcerative colitis (UC).

The clinical trial, which is registered as NCT05377580 on ClinicalTrials.gov, was a multicenter, randomized, double-blind, placebo-controlled study. Picankibart, coded as IBI112, is a recombinant antibody injection against the interleukin 23p19 subunit (IL-23p19). The study aimed to evaluate picankibart's effectiveness and safety for treating UC, utilizing both induction and maintenance phases.

A total of 150 subjects with a modified Mayo score of 4 to 9 and an endoscopic subscore of 2 or higher participated in the study. They were randomly assigned in a 1:1:1 ratio to receive either a placebo, 200 mg of picankibart, or 600 mg of picankibart via intravenous infusion at weeks 0, 4, and 8 during the induction period. Throughout the maintenance period, participants received a 200 mg subcutaneous injection of picankibart every 4 or 8 weeks. The primary endpoint was clinical remission at week 12, defined by a rectal bleeding subscore of 0, a stool frequency subscore of 1 or less, and an endoscopic subscore of 1 or less.

The results indicated that both primary and secondary endpoints were achieved. Clinical remission was significantly higher in the 200 mg picankibart group (20.0%) and the 600 mg group (14.0%) compared to the placebo group (2.0%; p < 0.05). Additionally, 54.0% and 68.0% of subjects in the 200 mg and 600 mg groups, respectively, achieved clinical response, compared to 22.0% for the placebo group (p < 0.001). Other secondary endpoints, including symptomatic remission, endoscopic remission, and histologic-endoscopic mucosal remission, were also significantly improved in the treatment groups compared to the placebo.

Safety profiles for picankibart were favorable and consistent with previous studies and other IL-23 class drugs, with no new safety concerns reported. The study's maintenance phase is ongoing, and the proportions of subjects achieving various forms of remission continue to improve. Detailed data are expected to be presented at future academic conferences or published in clinical journals.

Professor Minhu Chen, the Principal Investigator from the First Affiliated Hospital of Sun Yat-sen University, highlighted that ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum, with symptoms like abdominal pain, diarrhea, rectal bleeding, weight loss, and fatigue. Given the chronic and recurrent nature of the disease, there is a substantial need for new treatment options. He expressed optimism about the study's results and the potential of picankibart to offer new treatment avenues for Chinese patients.

Dr. Lei Qian, Senior Vice President of Clinical Development at Innovent, emphasized the impact of ulcerative colitis on patients' physical and mental health. He noted the promising results of the phase 2 study and expressed confidence in picankibart's potential for treating autoimmune diseases. Dr. Qian also mentioned that picankibart, developed by Innovent, is already under review by the NMPA for treating plaque psoriasis and hopes to expand its use to benefit a broader patient population.

Ulcerative colitis is described as a chronic inflammatory disease characterized by inflammation of the colon and rectum. Symptoms include frequent diarrhea, mucus, pus, blood in stools, and abdominal pain. The prevalence of ulcerative colitis is increasing in China, particularly among young and middle-aged individuals. Traditional treatments involve medication and surgery, but there are high incidences of adverse reactions. Recent advancements in targeting IL-12 and IL-23 have shown improved efficacy and safety. However, no IL-23p19 targeted drugs have been approved in China, indicating a significant unmet clinical need.

Picankibart (IBI112), developed by Innovent, targets the IL-23p19 subunit and prevents IL-23 from binding to cell receptors. It holds potential as a treatment for psoriasis, ulcerative colitis, and other autoimmune diseases. Multiple clinical studies are ongoing, including phase 3 trials for plaque psoriasis and phase 2 trials for ulcerative colitis. The NMPA has also accepted the new drug application for treating moderate to severe plaque psoriasis. Innovent, founded in 2011, aims to provide high-quality biopharmaceuticals for serious diseases and has multiple products and collaborations in its portfolio.