Covid-19: Zydus seeks DCGI approval to undertake clinical trials for antibody cocktail
Pharmaceutical major Zydus Cadila has sought national drugs controller’s permission to initiate phase 1/3 human clinical trials for its monoclonal antibodies to treat Coronavirus disease (Covid-19), the company announced on Thursday.
It is the only Indian company to have developed a neutralizing monoclonal antibody-based cocktail for the treatment of Covid-19.
“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 a patient’s suffering and discomfort. We believe that ZRC-3308 has the potential to address these concerns and provide a safe treatment,” said Sharvil Patel, managing director, Cadila Healthcare Ltd.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses.
It’s biological therapy, ZRC-3308, is a cocktail of two SARS-CoV-2-neutralizing monoclonal antibodies (mAbs) that the company says can emerge as one of the main treatments for mild Covid-19 because they significantly reduced viral load in mild patients and their rate of hospitalisation.
According to the company, 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, thereby reducing the risk of severe disease. ZRC-3308 has demonstrated the ability to neutralise SARS-CoV-2 both in vitro and in animal studies,” said the company in a statement.
“In animal studies, ZRC-3308 reduced damage to the lungs in both prophylactic and therapeutic settings. It 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 drugs controller General of India.”
This Monday, Roche India had launched its monoclonal antibodies for Covid-19 treatment in Indian market.