Biocon, Equillium announce positive data from Phase 2 Study evaluating Itolizumab for Ulcerative Colitis
Bengaluru: Equillium, Inc., a clinical-stage biotechnology company and Biocon Limited, an innovation-led global biopharmaceutical company, have announced positive topline results from the Phase 2 study evaluating itolizumab in the treatment of moderate to severe ulcerative colitis (UC).
The double-blinded, placebo- and active-controlled Phase 2 clinical study evaluated the safety and efficacy of itolizumab in biologic-naïve patients with moderate to severe active UC.
A total of 90 patients were randomized 1:1:1 to receive itolizumab (fixed dose of 140 mg), placebo, or adalimumab (a global standard of care biologic treatment used as an active control) every two weeks for an initial 12-week treatment period. The primary endpoint of the study was clinical remission as defined by Total Mayo Score, and secondary endpoints included the proportion of participants who achieved clinical response and endoscopic remission (evaluated by central endoscopy). The study was co-sponsored by Equillium and Biocon Limited and conducted at multiple clinical trial sites in India. The design and conduct of the trial were a collaborative effort, with input from the gastroenterology community and leading global clinical and scientific experts in the field of inflammatory bowel disease (IBD).
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