Zydus Cadila seeks DCGI approval to undertake clinical trials for monoclonal antibodies cocktail

Zydus Cadila, a pharmaceutical company, on Thursday, May 27, 2021, announced that its biological therapy ZRC-3308 can emerge as one of the main treatments for mild COVID-19.

Biological therapy ZRC-3308 is a cocktail of two SARS-CoV-2-neutralizing monoclonal antibodies (mAbs).

SARS-CoV-2 spike protein targeted, neutralizing monoclonal antibody-based treatments have received emergency use authorization in mild COVID-19 in the US, Europe and India because they significantly reduced viral load in mild patients and their rate of hospitalization.

Two of these products are cocktail based products comprising of two mAbs binding to two different epitopes on the spike protein of the SARS-CoV-2 virus. Cocktail of 2 mAbs based products is better equipped to deal with variants than single mAb-based products which have a tendency of losing their efficacy with rapidly generating variants.

Zydus is the only Indian company to have developed a neutralizing monoclonal antibody-based cocktail for the treatment of COVID-19.

Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said, "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 the patient's suffering and discomfort. We believe that ZRC-3308 has the potential to address these concerns and provide safe treatment."

Recently, the US FDA withdrew the emergency use authorization of a mAb product after new variants emerged in the country that was not being neutralized by the product.

ZRC-3308 is a cocktail of two monoclonal antibodies targeting two unique epitopes on the spike protein of SARS-CoV-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.

ZRC-3308 has demonstrated the ability to neutralize SARS-CoV-2 both in vitro and in animal studies. In animal studies, ZRC-3308 reduced damage to the lungs in both prophylactic and therapeutic settings. ZRC-3308 has been found to be safe and well-tolerated in animal toxicology studies.

Zydus is currently seeking permission to initiate phase 1/3 human clinical trials from the DCGI.