Equillium & Biocon Report Positive Phase 2 Results for Itolizumab in UC

Equillium, Inc., a clinical-stage biotechnology company, and Biocon 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 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).

“The CD6-ALCAM pathway is elevated in gastrointestinal inflammation and is associated with severity of disease in both ulcerative colitis and Crohn’s patients.  As such, we are delighted with the strength of data across the primary and secondary endpoints of this phase 2 study in moderate to severe ulcerative colitis patients,” said Dr. Stephen Connelly, chief scientific officer, Equillium.

“Itolizumab was well tolerated and achieved a clinical remission rate of 23 per cent despite an imbalance of more severe patients in the itolizumab arm compared to the other arms of the study.  While these positive results add to itolizumab’s critical mass of safety and efficacy data across different patient populations, we are particularly encouraged by this data in the context of our phase 3 EQUATOR study in acute graft-versus-host disease, where lower gastrointestinal pathogenesis is a key driver of mortality,” he added.

“Itolizumab demonstrated proof of concept with a meaningful effect size – comparable to biologic standard of care adalimumab – in this phase 2 study in subjects with moderate to severe ulcerative colitis. Itolizumab represents a novel selective immune modifying mechanism of action with great potential in a treatment paradigm needing differentiation and improved outcomes for patients,” said Dr Brian Feagan, Professor of Medicine at the Schulich School of Medicine & Dentistry, University of Western Ontario.

Baseline demographics of the study included a median age of 39 years, relatively equal proportions of male and female subjects evenly distributed among study arms, and a mean weight of 58 kilograms

Baseline disease severity of the study was greater in the itolizumab arm, where 23% of patients were classified as severe (Total Mayo Score of 11) versus 0% in the placebo and adalimumab arms, and 66% had left-sided colitis versus 30% and 43% in the placebo and adalimumab arms, respectively.

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