Zydus seeks DCGI nod for clinical trials

Healthcare and pharmaceutical major Zydus Cadila has sought the permission of Drugs Controller General of India (DCGI) to start human clinical trials for monoclonal antibodies cocktail to treat Covid-19.

Ahmedabad: Healthcare and pharmaceutical major Zydus Cadila has sought the permission of Drugs Controller General of India (DCGI) to start human clinical trials for monoclonal antibodies cocktail to treat Covid-19. The company’s biological therapy ZRC-3308 is a cocktail of two SARS-CoV-2 neutralizing monoclonal antibodies (mAbs) and it can emerge as one of the main treatments for mild Covid-19, the company said on Thursday.

According to Zydus Cadila, the neutralizing monoclonal antibody-based treatments have received emergency use authorization in mild Covid-19 in the US, Europe and in India because they significantly reduced viral load in mild patients and their rate of hospitalization.

Stating that Zydus is the only Indian company to have developed a neutralizing monoclonal antibody-based cocktail for the treatment of Covid-19, the Ahmedabad-based company added, “Zydus is currently seeking permission to initiate phase 1/3 human clinical trials from the DCGI.”

“At this juncture, there is a critical need to explore safer and more efficacious treatments to combat Covid-19. It is important to look at different stages of the disease progression and look at options that can reduce patient’s suffering and discomfort,” said Sharvil Patel, managing director, Cadila Healthcare Ltd, the flagship company of Zydus Cadila Group.

“We believe that ZRC-3308 has the potential to address these concerns and provide a safe treatment,” Patel added. ZRC-3308 has been found to be safe and well tolerated in animal toxicology studies, the company stated. tnn


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