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Biocon Says Clinical Study For Drug Itolizumab Initiated After Drug Regulator's Approval

Biocon Says Clinical Study For Drug Itolizumab Initiated After Drug Regulator's Approval

NDTV
Thursday, December 23, 2021 03:29:04 PM UTC

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.

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.

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