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

Pankaj Patel, Chairman Zydus Cadila (2)

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.

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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.

Monoclonal antibodies are emerging as important tools in the fight against COVID-19. The monoclonal antibodies act like natural antibodies by binding and destroying SARS-CoV-2 spike protein. Neutralising monoclonal antibody-based treatments have received emergency use authorisation in mild COVID-19 in the US, Europe and India because they significantly reduce viral load in mild patients and their rate of hospitalisation.

“At this juncture, there is a critical need to explore safer and more efficacious treatments to combat COVID-19," said Sharvil Patel, Managing Director, Cadila Healthcare.

"It is important to look at different stages of the disease progression and look at options that can reduce patient’s suffering and discomfort. We believe that ZRC-3308 has the potential to address these concerns and provide safe treatment,” Patel added.