Equillium Reports Positive Phase 2 Itolizumab Results for Ulcerative Colitis

Equillium, Inc., a biotechnology firm focusing on immune system biology to create new treatments for severe autoimmune and inflammatory conditions, together with Biocon Limited, an innovative biopharmaceutical company, have disclosed positive results from their Phase 2 clinical trial. This study assessed the efficacy and safety of itolizumab in addressing moderate to severe ulcerative colitis (UC).

The trial was structured as a double-blinded, placebo- and active-controlled Phase 2 study involving patients who had not previously been treated with biologics. It aimed to determine the effectiveness and safety of itolizumab in patients with active moderate to severe UC. A total of 90 participants were randomly allocated into one of three groups: those receiving itolizumab at a fixed dose of 140 mg, a placebo, or adalimumab, a well-established biologic treatment used as a comparator. These treatments were administered every two weeks over a 12-week period.

The primary focus of the trial was to achieve clinical remission, defined by the Total Mayo Score, a comprehensive measure of UC severity. Secondary goals included assessing the rate of clinical response and endoscopic remission, the latter being evaluated using central endoscopy. The trial was conducted across various sites in India, with Equillium and Biocon Limited co-sponsoring the study. The design and execution of the trial benefited from the insights of gastroenterology experts and renowned global professionals specializing in inflammatory bowel disease (IBD).

Results from the study showed that itolizumab led to a clinical remission rate of 23.3% after 12 weeks, compared to 20.0% for adalimumab and 10.0% for the placebo group. For the key secondary endpoint of endoscopic remission, itolizumab achieved a rate of 16.7%, matching that of adalimumab and surpassing the 6.7% seen with the placebo. These outcomes indicate that itolizumab is not only effective but also comparable to adalimumab, a standard treatment, suggesting a viable alternative for UC management.

Dr. Stephen Connelly, Equillium's chief scientific officer, highlighted the encouraging results of itolizumab, noting its potential despite the presence of more severe cases in the itolizumab group compared to other arms of the study. Furthermore, the positive findings bolster itsolizumab's safety and efficacy profile, which is also under evaluation in a Phase 3 study for acute graft-versus-host disease, where gastrointestinal involvement significantly affects patient outcomes.

Dr. Brian Feagan, a professor of medicine at the University of Western Ontario, emphasized the novel approach of itolizumab's immune-modifying action, offering significant promise for improving UC treatment outcomes. This innovative mechanism differentiates it from existing treatments, potentially offering better clinical results for patients.

The study's participants had an average age of 39 years, with a balanced gender distribution across the treatment groups. The initial disease severity was higher in the itolizumab group, with 23% classified as severe, whereas the placebo and adalimumab groups had no severe cases. Additionally, a greater proportion of participants in the itolizumab arm had left-sided colitis.

The study provides a solid foundation for further exploration of itolizumab in treating autoimmune diseases, supported by its ability to target and modulate specific immune pathways effectively. This particular study's success is anticipated to be presented at a scientific conference in 2025, contributing to the ongoing development and understanding of treatments for ulcerative colitis and potentially other inflammatory conditions.