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From its Phase 2 clinical research assessing itolizumab in patients with moderate to severe ulcerative colitis, Equillium (EQ, Financials) reported promising topline findings. Working with Biocon Limited, the trial found that after 12 weeks, itolizumab had a clinical remission rate of 23.3% surpassing adalimumab at 20.0% and placebo at 10.0%. Complementing adalimumab, the medicine also attained an endoscopic remission rate of 16.7%, much greater than the 6.7% seen in the placebo group.
Following the announcement, Equillium's stock surged 24.25% to $0.91 as of 1:50 p.m. ET on Thursday.
Enrolled in 90 biologic-naive patients, the randomized, double-blinded experiment allocated each individual to have either adalimumab, placebo, or isolizumab every two weeks throughout a 12-week course. With important goals including clinical remission, clinical response, and endoscopic remission, the trial was carried out in many Indian hospitals. Though the baseline illness severity was uneven, with more severe patients in the itolizumab arm, the medication showed great effectiveness when compared to the generally used standard-of-care therapy, adalimumab.The findings offer evidence of concept for the new mode of action of itolizumab, which specifically targets the CD6-ALCAM pathway to control T-cell activity in inflammatory disorders, according to Dr. Stephen Connelly, Chief Scientific Officer of Equellium. These results are especially pertinent, he underlined, for Equillium's current Phase 3 EQUATOR research in acute graft-versus-host disease, where lower gastrointestinal involvement is a major determinant of death.Reiterating its positive risk-benefit profile, the research also demonstrated that itolizumab was generally well tolerated with no new safety signals noted. Later in 2025 Equillium and Biocon want to release further results at a forthcoming scientific meeting.
This article first appeared on GuruFocus.