SAN FRANCISCO and SUZHOU, China, Oct. 16, 2024 /PRNewswire/ -- 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."

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 Europe and North America. And in China, the prevalence rate has been increasing gradually in the past 20 years with a prevalence rate of 11.6/100000. Ulcerative colitis is more common diagnosed in young and middle-aged people. The clinical treatment of ulcerative colitis is mainly medication and surgical treatment. Thiopurine is the most traditional immunosuppressant, however the incidence of adverse reactions is high. In terms of biologics, anti-TNF-α Monoclonal antibodies have problems such as loss of response caused by immunogenicity. In recent years, drugs targeting IL-12 and IL-23 have shown advantages in efficacy and safety in the treatment of ulcerative colitis. At present, no IL-23p19 targeted drugs were approved for the treatment of ulcerative colitis in China, representing a huge unmet clinical need.

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 September 2024, the NMPA accepted the first NDA for picankibart for the treatment of moderate to severe plaque psoriasis.

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, Adimab, LG Chem and MD Anderson Cancer Center.

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).

Forward-looking statement

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

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