Biocon Biologics yesterday announced that the 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 centres in India. Equalise is a phase-Ib open-label, proof-of-concept clinical study currently studying Lupus Nephritis patients in the Part B portion of the clinical trial, the company notified via a statement.
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 US 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, the statement further said.
Speaking in this regard, Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics, said, “We are happy to announce the commencement of our partner Equillium’s phase-Ib clinical study in India to evaluate the safety and early efficacy of Biocon Biologics’ novel antibody, Itolizumab, in treating Lupus Nephritis. 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 immuno-suppressive 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. Our partner Equillium has observed positive trends in the Part A portion of the phase-Ib study in SLE patients and hence is expanding the Part B portion of the study in Lupus Nephritis patients in the US and India.”