Zydus Cadila, the only Indian company that claims to have developed neutralising monoclonal antibodies (mAbs)-based cocktail for the treatment of Covid-19, has now been recommended to conduct clinical trials of the cocktail by the Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO), according to sources.
“SEC gives a recommendation for the Phase I and II clinical trials of Zydus Cadila’s biological therapy ZRC-3308, a cocktail of two SARS-CoV-2-neutralising monoclonal antibodies (mAbs) that can emerge as one of the main treatments for mild COVID-19,” the sources said.
These antibodies are made by cloning unique white blood cells. Domestic pharmaceutical major Zydus Cadila has sought the Drug Controller General of India (DCGI) permission recently to undertake clinical trials.
Zydus said that its biological therapy ZRC-3308, a cocktail of two SARS-CoV-2-neutralising monoclonal antibodies (mAbs) can emerge as one of the main treatments for mild Covid-19.
Currently, some of the hospitals are administering the cocktail of two fast-acting anti-bodies - Casirivimab and Imdevimab, the batch of the Roche Antibody Cocktail drug arrived in the country on May 24.
Another antibody cocktail that has received permission is Eli Lilly and Company, India announced that it has received permission for restricted emergency use of its antibody drugs, bamlanivimab 700mg and etesevimab 1400mg, in India for the treatment of patients with mild to moderate coronavirus disease 2019.