Biocon’s partner Equilium expands its EQUALISE study to Indian clinical centres

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The Indian pharma major Biocon Biologics Limited, on Thursday, announced that its U.S.-based partner firm, Equillium has expanded its EQUALISE study to clinical centers in India. Equilism is currently studying Lupus Nephritis patients in the Part B portion of the clinical trial.

Through the EQUALISE study, Equilism is evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and clinical activity of Itolizumab (ALZUMAb-L) in patients with SLE and Lupus Nephritis.

Itolizumab is a first-in-class anti-CD6 monoclonal antibody in clinical development that exclusively targets the CD6-ALCAM pathway. This pathway is important for controlling the activity and trafficking of T cells, which are responsible for a variety of immuno-inflammatory disorders.

“We are happy to announce the commencement of our partner Equillium’s Phase 1b 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 immunosuppressive drugs.

Dr. Sandeep Athalye, Chief Medical Officer, Biocon Biologics

Biocon, in its recent press release, states, ‘The trial design and initiation has been a joint effort with the Lupus community including working closely with leading global clinical and scientific experts in the Lupus field, the Lupus Research Alliance, and patients living with Lupus and/or Lupus Nephritis. Importantly, the study is also evaluating urinary biomarkers including soluble ALCAM and CD6, which may help address the heterogeneity of the disease and tackle a key issue that has been a challenging aspect of developing drugs in this field.’

“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 1b study in SLE patients and hence is expanding the Part B portion of the study in Lupus Nephritis patients in the U.S. and India.”

Dolca Thomas, M.D.

Dolca adds, “Even with recent U.S. FDA approvals, treatments for patients with lupus nephritis have significant side effect profiles and do not result in complete responses for most patients, which are critical for long-term kidney survival,”

ALZUMAb-L is the Biocon Biologics brand of Itolizumab, a new anti-CD6 antibody for chronic plaque psoriasis that has been on the market in India since 2013. The DCGI has also granted its restricted emergency use authorization for the treatment of moderate to severe acute respiratory distress syndrome (ARDS) in COVID-19 patients.

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