Innovent Announces Phase 2 Clinical Study of Picankibart (IBI112) in Chinese Patients with Ulcerative Colitis Met Primary Endpoint
SAN FRANCISCO and SUZHOU, China,
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.
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About Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory disease characterized by mucosal inflammation of the colon and rectum, with typical symptoms such as recurrent diarrhea, mucus, pus and blood stool with abdominal pain, and urgency. Ulcerative colitis is a serious threat to physical health and has an impact on daily life and mental health for patients. Ulcerative colitis is common in
About Picankibart (IBI112)
Picankibart (IBI112) is a monoclonal antibody independently developed by Innovent with proprietary intellectual property rights. This product specifically targets the IL-23p19 subunit, preventing IL-23 from binding to cell surface receptors. Picankibart has the potential to offer a more effective treatment option for patients with psoriasis, ulcerative colitis or other autoimmune diseases.
Currently, multiple clinical studies of picankibart are underway, including:
- Phase 3 study conducted in patients with moderate to severe plaque psoriasis (CLEAR-1), which has reached the study endpoints in
May 2024 ; - Phase 3 study conducted in patients with moderate to severe plaque psoriasis with randomized withdrawal and re-treatment;
- Phase 2 study in patients with moderate to severe plaque psoriasis who were previously treated with biologics;
- Phase 2 study in patients with moderate to severe active ulcerative colitis.
In
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte,
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).
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