Itolizumab is a first-in-class, anti-CD6 IgG1 monoclonal antibody with a unique mechanism of action and a proven safety profile. Originally developed by scientists at Biocon as a psoriasis treatment, the molecule is manufactured at Biocon’s biologics manufacturing facilities and has been available under the brand name ALZUMAb® in India since 2013 for treating acute psoriasis.
Biocon decided to repurpose Itolizumab and conducted a Phase II clinical trial in leading hospitals in major cities in India with the hope that Itolizumab would benefit COVID-19 patients as the molecule’s unique mechanism of action works against the Cytokine Release Syndrome (CRS), which has been found to be one of the causes of mortality in COVID-19 patients.
A multi-centric, open label, two-arm randomized, controlled clinical trial was conducted to study the efficacy and safety of Itolizumab in COVID-19 patients displaying moderate to severe ARDS (acute respiratory distress syndrome) symptoms, and yielded positive results.
After review of the data from the clinical trial of Itolizumab in COVID-19 complications, the Drugs Controller General of India (DCGI), acting on a recommendation from the Subject Expert Committee (SEC), granted ‘Restricted Emergency Use’ approval to Itolizumab in July 2020 for use in treating CRS in ARDS patients due to COVID-19, in addition to already approved indications under the Drugs & Cosmetics Act.
Based on the encouraging study results in India, Biocon’s U.S.-based partner, Equilllium is planning to conduct a global randomized controlled clinical trial of Itolizumab in COVID-19 patients.
Biocon’s Cuban partner, Centre of Molecular Immunology, has also reported promising results from treating COVID-19 patients with Itolizumab.