Itolizumab – Biocon Ltd. novel drug (Alzumab) approved in 2012 for Psoriasis and manufactured in India March 2020. During pandemic lockout 1.0 Bioinnovat conducted Phase III clinical Trial for repurposing for ARDS for moderate to severe hospitalized patients prior to ventilator. Bioinnovat managed the sites in Delhi recruiting more than half of the enrolment and supported EUA approval within 2 Months by July.
The clinical study included three reviews by DCGI, protocol amendments and a global benchmarking audit. Bioinnovat was responsible for entire end to end management of the study in Delhi under Dr. Suresh Kumar, Medical Director Lok Nayak Hospital and Dr. Randeep Guleria, Director, AIIMS for almost half the trial subjects. The other major Mumbai contributors were Dr. Rosemarie D Souza, Nair Hospital and Dr. Wasim Khot, KEM Hospital, Mumbai. This Phase III study in India led to a global study approval in USA for Itolizumab which has not been conducted by Biocon partner Equillium. (Currently Bioinnovat is engaged by Equillium in India for a Lupus Nephritis study for Itolizumab for Phase Ib/II)
Regulatory support and follow up to FDA/DCGI for each Phase including recommendation from leading PI’s. Currently engaged in bringing Itolizumab on the countries National Protocol ICMR like Tocilizumab.
Supporting Phase IV Clinical Trial with resourcing of site coordinators for study of 300 patients being conducted by IQVIA.