Biocon Biologics says clinical study for drug Itolizumab initiated in India after approval from DCGI

Biocon Biologics, an arm of biotechnology major Biocon, on Thursday said the clinical study for its biologic drug Itolizumab for the possible indication in autoimmune disease Lupus Nephritis has been initiated in India after approval from the Drugs Controller General of India.

Biocon’s partner US-based Equillium Inc has expanded its ‘EQUALISE’ study in Systemic Lupus Erythematosus (SLE) and Lupus Nephritis for Itolizumab to clinical centers in India, Biocon Ltd said in a regulatory filing.

“Equillium has initiated this study across several tertiary hospitals specialised to deal with Lupus Nephritis patients in India after obtaining approval from the Drugs Controller General of India (DCGI),” it said.

The company said EQUALISE is a Phase 1b openlabel, proof-of-concept clinical study currently studying Lupus Nephritis patients in the Part B portion of the clinical trial.

In India, about 45,000 patients are diagnosed with autoimmune disease Systemic Lupus Erythematosus (SLE). Of this, over 20,000 patients have kidney involvement (nephritis), many of which do not respond to standard available therapy with steroids and immunosuppressive drugs, Biocon Biologics Chief Medical Officer Sandeep Athalye said.

The company believes that Itolizumab can address this unmet need for Lupus with better remission rates, more durable responses, and a better safety profile, he added.

“Our partner Equillium has observed positive trends in the Part-A portion of the Phase 1b study in SLE patients and, hence, is expanding the Part-B portion of the study in Lupus Nephritis patients in the US and India,” Athalye said.