India begins clinical trial of Biocon’s Ulcerative Colitis drug; Report

In conjunction with the biopharmaceutical company Equillium Inc., Biocon Limited announced on Wednesday the beginning of a clinical investigation using the monoclonal antibody Itolizumab in patients with Ulcerative Colitis (UC) in India.  Itolizumab’s safety and effectiveness in treating individuals with moderate to highly active UC are being assessed in this phase two randomised, double-blind research.

The study will focus on several tertiary hospitals with expertise in treating UC cases after receiving approval from the Drugs Controller General of India (DCGI), the company said in a statement. It also added that the first patient who intended to participate in the study was screened on December 1, 2022.

‘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,’ Siddharth Mittal, Managing Director and CEO, Biocon Limited, said.

India has the highest reported incidence of IBD (9.31 cases per 100,000 people) and ulcerative colitis (5.41 cases per 100,000 people) among the developing countries. Many of these patients don’t improve with commonly prescribed treatments like corticosteroids, 5-ASA, and immunosuppressive medications like TNF alpha inhibitors. With improved remission rates, more enduring responses, 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.

Diarrhoea and rectal bleeding are common symptoms of ulcerative colitis, a chronic relapsing condition marked by damaging intestine inflammation and epithelial damage. Itolizumab is being tested in a clinical research by Biocon and Equillium for patients with moderate to highly active UC. In this study, participants receive a fixed dose of 140 mg every two weeks for a total of six months. With assistance from the gastroenterology community and top international clinical and scientific specialists in the field of UC and inflammatory bowel disease, the trial’s design and launch have been joint efforts.