Equillium's Itolizumab Shines in Phase 2 UC Trial, Stock Soars

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company, has announced positive topline results from its Phase 2 study evaluating itolizumab in the treatment of moderate to severe ulcerative colitis (UC). The drug demonstrated clinical efficacy after 12 weeks of treatment, achieving a clinical remission rate of 23.3% compared to 20.0% for adalimumab and 10.0% for placebo. Itolizumab also achieved key secondary endpoints, including endoscopic remission of 16.7% compared to 16.7% for adalimumab and 6.7% for placebo. Notably, itolizumab was generally well tolerated, with no safety signals observed.

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).



Dr. Stephen Connelly, chief scientific officer at Equillium, commented on the results, "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. Itolizumab was well tolerated and achieved a clinical remission rate of 23 percent 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, with topline data expected this quarter."

Dr. Brian Feagan, Professor of Medicine at the Schulich School of Medicine & Dentistry at the University of Western Ontario, also weighed in on the results, stating, "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."

The positive results from the Phase 2 study in UC, combined with the ongoing Phase 3 EQUATOR study in acute graft-versus-host disease, could attract strategic partnerships or investment opportunities for Equillium. Pharmaceutical companies with a strong presence in the IBD or transplantation markets may be interested in partnering with Equillium to commercialize itolizumab in these areas. Additionally, institutional investors may be attracted to Equillium's potential for growth and value creation, given the strong clinical data and favorable safety profile of itolizumab.

In conclusion, Equillium's positive Phase 2 results for itolizumab in ulcerative colitis have positioned the drug as a competitive alternative in the IBD market, with a unique mechanism of action and a favorable safety profile. As the company awaits topline data from the Phase 3 EQUATOR study in acute graft-versus-host disease, investors and strategic partners may be drawn to Equillium's potential for growth and value creation in the competitive IBD market.