Biocon Limited, an innovation-led global biopharmaceutical company, has announced the initiation of the clinical study of Itolizumab in patients with Ulcerative Colitis (UC) in India, in collaboration with Equillium.

This is a phase two randomized, double-blind, parallel-group, placebo and active-controlled (adalimumab), two treatment period study to evaluate the safety and efficacy of Itolizumab for the induction of remission in biologics naïve patients with moderate to severely active UC.

Having obtained approval from the Drugs Controller General of India (DCGI), the study will cover several tertiary hospitals specialized in handling UC cases. The first patient who intended to participate in the study was screened on December 1, 2022.

Siddharth Mittal, Managing Director and CEO, Biocon Limited, said, "We are encouraged by the progress being made on our high-value, multi-indication molecule, Itolizumab, in collaboration with Equillium. The commencement of the Phase two clinical study, that will determine its efficacy for the treatment of Ulcerative Colitis, is an important step forward in our efforts to bring its benefit 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."

Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics, added, "Among the developing regions of the world, India has the highest reported incidence of 9.31 cases per 100,000 persons for Inflammatory Bowel Disease and 5.41 cases per 100,000 persons for Ulcerative Colitis. Many of these cases do not respond to standard available therapy, such as corticosteroids, 5 Amino Salicylates (5-ASA) and immunosuppressive drugs, including TNF alfa inhibitors. We believe that Itolizumab can address this need for the treatment of UC, with better remission rates, more durable responses, and a better safety profile."

Commenting on the development, Dr Maple Fung, Senior Vice President of Clinical Development, Equillium Inc., said: "T cells play a pivotal role in the immune response that leads to Inflammatory Bowel Disease and preclinical models show a role for CD6 in disease pathogenesis. As Itolizumab has a novel dual mechanism of action that modulates both the activity and trafficking of CD6-expressing T effector cells, it is an ideal 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 responses, particularly in those with lower gastroenterological symptoms."