Innovent Announces First Patient Dosed in a Phase 2 Clinical study of IBI112 (IL-23p19 Monoclonal Antibody) in Patients with Moderate-to-Severe Active Ulcerative Colitis
Excerpt from the Press Release:
SAN FRANCISCO and SUZHOU, China , July 3, 2022 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, autoimmune, metabolic, ophthalmology and other major diseases, announced that the first patient with moderate-to-severe active ulcerative colitis has been successfully dosed in a Phase 2 clinical study (clinicaltrials.gov, NCT05377580) of its innovative recombinant anti-interleukin 23p19 subunit antibody injection (R & D code: IBI112) in China.
The study is a multi-center, randomized, double-blind, parallel, placebo-controlled Phase 2 clinical study, evaluating the efficacy and safety of IBI112 in the treatment of moderate-to-severe active ulcerative colitis. The primary objective of the study is to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of IBI112 induction and maintenance therapy in Chinese patients with moderate-to-severe active ulcerative colitis. This is also the first Phase 2 clinical study of domestic innovative drugs targeting IL-23p19 for UC patients in China, which marks a significant milestone. Innovent will continue to leverage its fast execution capabilities in the clinical development and research and strive to provide better treatment options for UC patients.
Professor Minhu Chen from The First Affiliated Hospital of Sun Yat Sen University, the principal investigator of the study, stated, “The pathogenesis of ulcerative colitis is complex, which is related to genetic, immune, environmental and other factors.
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