Biocon starts clinical study to evaluate efficacy of Itolizumab for Ulcerative Colitis patients

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

PTIUpdated: Thursday, December 15, 2022, 01:29 PM IST
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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.

According to Biocon, this is a phase 2 randomised, double-blind, parallel-group, placebo and active-controlled (adalimumab) study over two treatment periods to assess the safety and efficacy of itolizumab for the induction of remission in biologics-naive patients with moderately to severely active Ulcerative Colitis (UC).

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.

The first patient who intended to participate in the study was screened on December 1, 2022, the company said.

"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," Biocon Managing Director and CEO Siddharth Mittal said.

The development also underpins the company's commitment to bring innovative, affordable medicines, that address unmet patient needs, to market expeditiously, he added.

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