In India, Biocon Has Begun a Clinical Study for a Medication Intended to Treat Ulcerative Colitis

Biocon Limited and Equillium Inc. made a joint statement on the start of a clinical trial using the monoclonal antibody Itolizumab for Ulcerative Colitis (UC) patients in India.

In India, Biocon Has Begun a Clinical Study for a Medication Intended to Treat Ulcerative Colitis

Biocon Limited and Equillium Inc. made a joint statement on the start of a clinical trial using the monoclonal antibody Itolizumab for Ulcerative Colitis (UC) patients in India. In this phase two randomised, double-blind study, itolizumab's safety and efficacy in treating patients with moderate to very active UC will be evaluated. After getting clearance from the Drugs Controller General of India, the trial would concentrate on select tertiary institutions with experience treating UC cases, the business said in a statement (DCGI). The business added that on December 1, 2022, a screening was conducted for the first patient who planned to take part in the trial.

The development of our high-value, multi-indication drug, Itolizumab, in combination with Equillium, gives hope. Siddharth Mittal, Managing Director and CEO of Biocon Limited, stated that the start of the Phase 2 clinical study, which will evaluate its effectiveness for the treatment of Ulcerative Colitis, is a significant step forward in our efforts to bring its benefit to patients in India suffering from this disease. India has the highest reported incidence of inflammatory bowel disease among developing nations, with 9.31 cases per 100,000 people and 5.41 cases per 100,000 people, respectively.

Many of these patients don't react to commonly prescribed treatments like corticosteroids, 5-ASA, and immunosuppressive medications like TNF alpha inhibitors. With improved remission rates, more lasting effects, and a better safety profile, itolizumab can fulfil this demand for the treatment of UC, according to Dr. Sandeep Athalye, Chief Medical Officer, Biocon Biologics. The digestive system is damaged by destructive inflammation and epithelial injury in ulcerative colitis, a chronic relapsing illness that causes symptoms including diarrhoea and rectal bleeding.

In an ongoing clinical research conducted by Biocon and Equillium, patients with moderate to highly active UC are given a fixed dosage of 140 mg every two weeks for a duration of six months in order to assess the safety and effectiveness of itolizumab. The gastroenterology community and top international clinical and scientific specialists in the fields of UC and inflammatory bowel disease have all contributed to the trial's design and launch.

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