On Wednesday, Biocon Limited and biopharmaceutical company Equillium Inc. jointly announced the start of a clinical trial using the monoclonal antibody Itolizumab in patients with Ulcerative Colitis (UC) in India.
Itolizumab’s safety and effectiveness are being assessed in this phase two randomised, double-blind research in individuals with moderate to severely active UC. The study would encompass many tertiary hospitals with UC-specific expertise after receiving approval from the Drugs Controller General of India (DCGI), the business said in a statement. It added that the first patient who wished to enrol in the study was screened on December 1, 2022.
“The development of our high-value, multi-indication drug, Itolizumab, in association with Equillium, gives us 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 IBD (9.31 cases per 100,000 people) and ulcerative colitis (5.41 cases per 100,000 people) among the world’s developing nations.
Many of these patients don’t respond 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 tract is damaged by destructive inflammation and epithelial injury in ulcerative colitis, a chronic relapsing illness that causes symptoms like 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 efficacy of itolizumab. The gastroenterology community and top international clinical and scientific experts in the fields of UC and inflammatory bowel disease have all contributed to the trial’s design and launch.