Equillium, Inc. and Biocon Limited have announced positive topline results from their Phase 2 clinical trial evaluating itolizumab for moderate to severe ulcerative colitis (UC), with efficacy comparable to the established biologic treatment adalimumab.
Clinical Efficacy and Key Outcomes
The double-blinded study demonstrated that itolizumab achieved a clinical remission rate of 23.3% after 12 weeks of treatment, compared to 20.0% for adalimumab and 10.0% for placebo. The drug also showed strong performance in secondary endpoints, with a 63.3% clinical response rate and 16.7% endoscopic remission rate.
These results are particularly noteworthy given that the itolizumab arm included a higher proportion of severe cases, with 23% of patients classified as severe (Total Mayo Score of 11) compared to none in the placebo and adalimumab groups.
Study Design and Patient Population
The trial enrolled 90 biologic-naïve patients who were randomized equally across three treatment arms:
- Itolizumab (140 mg fixed dose)
- Adalimumab (standard of care)
- Placebo
Treatment was administered every two weeks during the initial 12-week period. The study population had a median age of 39 years, with balanced gender distribution and a mean weight of 58 kilograms.
Novel Mechanism of Action
Dr. Stephen Connelly, chief scientific officer at Equillium, highlighted the significance of targeting the CD6-ALCAM pathway, which is elevated in gastrointestinal inflammation. "Itolizumab represents a first-in-class approach to treating inflammatory bowel disease by modulating this important pathway," he explained.
Expert Commentary
Dr. Brian Feagan, Professor of Medicine at the Schulich School of Medicine & Dentistry, University of Western Ontario, emphasized the drug's potential: "Itolizumab represents a novel selective immune modifying mechanism of action with great potential in a treatment paradigm needing differentiation and improved outcomes for patients."
Safety Profile and Future Implications
The drug was generally well-tolerated throughout the study, consistent with previous clinical experience. These positive results have broader implications for itolizumab's development program, particularly for the ongoing Phase 3 EQUATOR study in acute graft-versus-host disease, where gastrointestinal inflammation plays a crucial role.
Additional data from this Phase 2 study is expected to be presented at a scientific conference during 2025, potentially providing deeper insights into itolizumab's therapeutic potential in inflammatory bowel disease.
