Biotechnology major, Biocon, on Wednesday, said it has initiated a clinical study in collaboration with Equillium Inc to evaluate efficacy of Itolizumab in patients with Ulcerative Colitis.
This is a phase two randomised, 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 naive patients with moderate to severely active Ulcerative Colitis (UC), Biocon said in a statement.
Having obtained approval from the Drugs Controller General of India (DCGI), the study will cover several tertiary hospitals specialised in handling UC cases, it added.
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Once the amendments to the New Drugs and Clinical Trials Rules, 2019, are approved and notified by the Health Ministry, India will become the second country in the world to adopt such innovative and cutting-edge technologies
The first patient who intended to participate in the study was screened on December 1, 2022, the company said.
“The commencement of Phase two clinical study, which 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,” Biocon Managing Director and CEO Siddharth Mittal said.
The development also underpins the company’s commitment to bring innovative, affordable medicines, which address unmet patient needs, to market expeditiously, he added.