Equillium announces itolizumab study achieves secondary endpoint

Equillium (EQ) and Biocon announced topline results from the Phase 2 study evaluating itolizumab in the treatment of moderate to severe ulcerative colitis. The double-blinded, placebo- and active-controlled Phase 2 clinical study evaluated the safety and efficacy of itolizumab in biologic-naive patients with moderate to severe active UC. A total of 90 patients were randomized 1:1:1 to receive itolizumab, placebo, or adalimumab 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. 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. 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 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. The primary endpoint of the study was clinical remission, defined as Total Mayo Score of 2 with no individual sub-score greater than 1 at Week 12. Secondary endpoints included the proportion of participants who achieved clinical response and endoscopic remission at Week 12 and Week 24. Additional data is expected to be presented at a future scientific conference during 2025. 23.3% clinical remission in the itolizumab arm at 12 weeks vs. 20.0% in adalimumab vs. 10.0% in placebo 63.3% clinical response in the itolizumab arm at 12 weeks vs. 60.0% in adalimumab vs. 46.7% in placebo 16.7% endoscopic remission in the itolizumab arm at 12 weeks vs. 16.7% in adalimumab vs. 6.7% in placebo. Itolizumab was generally well tolerated, and no safety signal was observed.