Clinical Study for Itolizumab initiated in India

Equillium has initiated this study in several tertiary hospitals in India, which specialise in dealing with Lupus Nephritis patients.

Clinical Trial Research
Clinical Trial

Last Updated on January 6, 2024 by The Health Master

Bengaluru : 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 in several tertiary hospitals in India, which specialise in dealing with Lupus Nephritis patients. The study commenced after obtaining prior approval from the regulating body Drugs Controller General of India (DCGI).

Systemic Lupus Erythematosus or Lupus, is an autoimmune chronic inflammatory disease. The prevalence of SLE in the United States is reported to be between 20 to 150 cases per 100,000 population while it declines to 3.2 per 100,000 people in India.

Announcing the clinical study to treat Lupus in India, Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics said, “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.”

Informing about expected positive results from the Part B study, he added, “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 US. and India.”

Biocon had earlier out-licensed Itolizumab to the U.S.-based biotechnology company Equillium in 2017 to help them develop this molecule for the treatment of severe autoimmune and inflammatory disorders.

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays the central role in modulating the activity and trafficking of T cells that drive several immune inflammatory diseases. This unique molecule holds the potential for multiple high value indications.

Equillium is currently developing Itolizumab for multiple indications, including acute graft-versus-host-disease (aGVHD), Lupus and Lupus Nephritis and uncontrolled Asthma.

Equillium in March released favorable topline data from the Type A group of the EQUALISE study in patients with SLE which showed that Itolizumab was safe and well tolerated.

In addition, Itolizumab demonstrated a dose-dependent reduction of cell surface CD6 expression on effector T cells, a leading indicator of drug activity, consistent with its mechanism of action. The initial data from the study also demonstrated a favorable safety and tolerability profile for subcutaneous delivery of Itolizumab in SLE patients.

The EQUALISE study is currently evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) and clinical activity of Itolizumab in patients with SLE and Lupus Nephritis.

The leading global clinical and scientific experts in the Lupus field, the Lupus Research Alliance, and patients living with Lupus and/or Lupus Nephritis have worked together to develop the trial design and initiation.

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.

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