Zydus Cadila seeks permission from DCGI to test its COVID-19 antibody cocktail on humans

Cadila Healthcare (Zydus Cadila) on May 27 said it has sought permission from the Drug Controller General of India (DCGI) to undertake human testing of its novel monoclonal antibody cocktail that can neutralise COVID-19 infection.

Zydus said the monoclonal antibody cocktail ZRC-3308 has been found to be safe and well-tolerated in animal toxicology studies and has demonstrated the ability to neutralise 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," the company said.

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

ZRC-3308 consists of two monoclonal antibodies to combat mild COVID 19 and is designed to have a long half-life providing protection for a long period of time.

Zydus said the antibody cocktail is better equipped to deal with variants than the single antibody product and in animal studies, ZRC-3308 reduced the SARS-CoV-2-mediated damage to the lungs. The company said the drug has reduced immune-effector functions to minimise potential tissue-damaging side effects of virus neutralising monoclonal antibodies thereby providing a safer product.