China-based Innovent Biologics, Inc. (HKG: 1801) announced the successful first patient dosing in a Phase II clinical study (clinicaltrials.gov: NCT05377580) for its IBI112, a recombinant anti-interleukin 23p19 subunit antibody, in moderate-to-severe active ulcerative colitis (UC). The multi-center, randomized, double-blind, parallel, placebo-controlled Phase II clinical study aims to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of IBI112 induction and maintenance therapy in Chinese patients with moderate-to-severe active UC.
Study Design
The study is designed to assess the therapeutic potential of IBI112 in patients with moderate-to-severe UC. The multi-center approach ensures a diverse patient population, enhancing the reliability of the study results. The randomized, double-blind, and placebo-controlled design ensures unbiased evaluation of the drug’s efficacy and safety.
Drug Profile
IBI112, independently developed by Innovent with proprietary intellectual property rights, is a monoclonal antibody that specifically binds to the IL-23p19 subunit. By preventing IL-23 from binding to cell surface receptors, IBI112 inhibits the IL-23 receptor-mediated signaling pathway. Preclinical data have shown that IBI112 has a clear target, a well-elucidated mechanism of action, and significant anti-inflammatory effects. The drug has been verified to be safe and well-tolerated in a Phase I clinical study, showing promise as an effective treatment option for patients with inflammatory bowel disease, including UC and other autoimmune diseases.-Fineline Info & Tech
