Equillium’s Partner Biocon Initiates Phase 2 Study of Itolizumab in Ulcerative Colitis

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that Biocon Limited, in collaboration with Equillium, has initiated a Phase 2 clinical study of itolizumab in patients with ulcerative colitis (UC).

The Phase 2 double-blinded placebo-controlled clinical study is evaluating the safety and efficacy of itolizumab for biologics-naïve patients with moderate to severe active UC, where patients are randomized 1:1:1 to receive a fixed dose of 140 mg of itolizumab, adalimumab, or placebo every two weeks for a 12-week treatment period, with adalimumab non-responders able to cross over to itolizumab. The study is expected to enroll up to 90 patients in multiple clinical trial sites in India. The trial design and initiation have been a collaborative effort, with help from the gastroenterologist community and leading global clinical and scientific experts in the field of inflammatory bowel disease (IBD).

“T cells play a pivotal role in the immune response that leads to IBD and preclinical models show a role for CD6 in disease pathogenesis,” said Dr. Maple Fung, senior vice president of clinical development at Equillium. “As itolizumab has a novel dual mechanism of action that modulates both the activity and trafficking of CD6-expressing T effector cells, it is a promising candidate for treatment of ulcerative colitis, where the severe inflammation can be debilitating. Additional supportive rationale can be found in our ongoing program investigating itolizumab in severe acute graft-versus-host disease, where our Phase 1b EQUATE study demonstrated meaningful complete responses, particularly in those with lower gastroenterological symptoms. We’re excited to see the UC study begin enrollment, as it may provide evidence of an efficacy signal for the use of itolizumab in the treatment of patients with ulcerative colitis.”

“We are encouraged by the progress being made on our high-value, multi-indication molecule, itolizumab, in collaboration with Equillium,” said Siddharth Mittal, managing director and chief executive officer of Biocon Limited. “The commencement of the Phase 2 clinical study, that will provide data related to its efficacy as a treatment of ulcerative colitis, is an important step forward in our efforts to bring the potential benefit of itolizumab to patients in India suffering from this disease. The development also underpins Biocon’s commitment to bring innovative, affordable medicines, that address unmet patient needs, to market expeditiously.”