Zydus seeks DCGI approval for clinical trial of monoclonal antibodies cocktail
NEW DELHI: SARS-CoV-2 spike protein targeted, neutralizing monoclonal antibody based treatments have received emergency use authorization in mild COVID cases in the US, Europe and in 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 SARS-CoV-2 virus. Cocktail of 2 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.
Zydus is the only Indian company to have developed a neutralizing monoclonal antibody-based cocktail for the treatment of COVID-19.
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 were not being neutralized by the product. ZRC-3308 is a cocktail of two monoclonal antibodies targeting two unique epitopes 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.
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.