Biocon Describes Clinical Study Enabling Approval of Itolizumab for COVID-19 in India; Novel Anti-CD6 Monoclonal Antibody Reduces Release of Pro-Inflammatory Cytokines, Controls “Cytokine Storm,” & Reduces COVID-19 Mortality

On July 13, 2020, Biocon Ltd. (BSE code: 532523, NSE: BIOCON), an innovation-led global biopharmaceuticals company, headquartered in Bengaluru, Karntaka, India, presented key insights into the results of the pivotal study that demonstrated its novel biologic, itolizumab, significantly reduced mortality in moderate to severe ARDS (acute respiratory distress syndrome) patients hospitalized with COVID-19, in India. This led to the Drug Controller General of India (DCGI) approving this novel biologic therapy for restricted emergency use in India. Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said: “Itolizumab is a ‘Made in India,’ ‘Innovated in India,’ first-in-class anti-CD6 monoclonal antibody, which has a seven-year proven track record of safety as doctors in India have been prescribing this biologic therapy to treat acute psoriasis. As itolizumab has been approved in India and given that we are in the middle of a medical emergency, the regulator has approved Biocon’s product for emergency use based on compelling data from a pivotal clinical trial involving a cohort of 30 patients. The two-arm, randomized study met both the primary and secondary endpoints, with the Itolizumab arm demonstrating statistically significant advantage over the control arm, culminating in the drug’s approval for restricted emergency use by the DCGI. The study results show that itolizumab’s unique mechanism of action can bring down mortality in moderate to severe ARDS patients due to COVID-19.”
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