Biocon starts clinical trial of drug meant to treat Ulcerative Colitis in India
Biocon Limited announced the initiation of the clinical study of Itolizumab, a monoclonal antibody in patients with Ulcerative Colitis (UC) in India, in collaboration with biopharmaceutical firm Equillium Inc.
This is a phase two randomised, double-blind study to evaluate the safety and efficacy of Itolizumab in 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 company said in a statement adding 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.
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. Itolizumab can address this need for the treatment of UC, with better remission rates, more durable responses, and a better safety profile,” said Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics.
Ulcerative Colitis is a chronic relapsing disorder, characterised by destructive inflammation and epithelial injury in the gastrointestinal tract, with symptoms like diarrhoea and rectal bleeding. Biocon and Equillium’s ongoing clinical study is evaluating the safety and efficacy of Itolizumab for patients with moderate to severely active UC, where patients are administered a fixed dosage of 140 mg every two weeks for six months. The trial design and initiation has been a collaborative effort, with help from the gastroenterologist community and leading global, clinical and scientific experts in the field of Inflammatory Bowel Disease and UC