Zydus Cadila seeks DCGI nod for human trials of Covid-19 antibody cocktail

Domestic pharmaceutical major Zydus Cadila has sought the Drug Controller General of India (DCGI) permission to undertake clinical trials of a monoclonal antibodies cocktail that can neutralise COVID-19 infection.

Zydus is the only Indian company which claims to have developed a neutralising monoclonal antibodies (mAbs) based cocktail for the treatment of COVID 19. These antibodies are made by cloning unique white blood cells.

Zydus said 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.

SARS-CoV-2 spike protein targeted, neutralising monoclonal antibody-based treatments have received emergency use authorisation in the US, Europe and in India because they significantly reduced viral load in mild patients, decreasing risk hospitalisation. Cocktail of two mAbs based products are better equipped to deal with variants than single mAb based products which have a tendency of losing their efficacy with rapidly generating variants.

"At this juncture, there is a critical need to explore safer and more efficacious treatments to combat COVID. It is important to look at different stages of the disease progression and look at options that can reduce patient's suffering and discomfort. We believe that ZRC-3308 has the potential to address these concerns and provide a safe treatment," said Dr. Sharvil Patel, Managing Director, Cadila Healthcare.  

Last year India's drug regulator had allowed "restricted emergency use" of Biocon's monoclonal antibody Itolizumab, a medicine used to cure psoriasis, to treat COVID-19. The US Food and Drug Administration (FDA) had revoked the emergency use authorisation (EUA) granted to Eli Lilly's bamlanivimab (LY-CoV555) alone for treating mild-to-moderate Covid-19 in adults and certain paediatric patients, as the drug was found to be ineffective against variants of the virus.

ZRC-3308 is a cocktail of two monoclonal antibodies targeting two unique epitopes (the specific piece of the antigen to which an antibody binds) on the spike protein of SARSCoV-2. The monoclonal antibodies of ZRC-3308 have been specifically designed to provide protection for a much longer period of time than the currently approved products. The enhanced design would also help in preventing any further tissue damage and thereby reducing the risk of severe disease, said Zydus Cadila.