Sunday, 22 May 2022

Clinical study for Itolizumab in Lupus Nephritis starts in India

23 December 2021 | News

For filling a significant unmet medical need for lupus nephritis patients

image credit- shutterstock

image credit- shutterstock

US-based Equillium Inc., Biocon’s partner, has expanded its EQUALISE study in Systemic Lupus Erythematosus (SLE) and Lupus Nephritis for Itolizumab (ALZUMAb-L) to clinical centers in India.

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

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).

Systemic Lupus Erythematosus, or Lupus, is an autoimmune chronic inflammatory disease. The prevalence of SLE in the U.S. has been reported to be between 20 to 150 cases per 100,000. In India, the reported prevalence of SLE is 3.2 per 100,000.

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

 We believe that ALZUMAb-L (Itolizumab) can address this unmet need for Lupus with better remission rates, more durable responses, and a better safety profile.”

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