Biocon has initiated a clinical study in collaboration with Equillium to evaluate efficacy of Itolizumab in patients with Ulcerative Colitis.
This is a phase-II 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.
The first patient who intended to participate in the study was screened on 1st December, 2022, the company said.
“The commencement of the phase-II 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 (MD) and CEO, Biocon, said.
The development also underpins the company’s commitment to bring innovative, affordable medicines, that address unmet patient needs, to market expeditiously, he added.
Edits by EP News Bureau