Zydus Cadila seeks DCGI nod for human clinical trials of antibodies cocktail to treat COVID-19

Zydus Cadila on Thursday said it is seeking permission from the Drugs Controller General of India (DCGI) to initiate human clinical trials for its monoclonal antibodies cocktail for the treatment of COVID-19.

"Zydus is seeking permission to initiate phase 1/3 human clinical trials from the DCGI... ZRC-3308 — a cocktail of two SARS-CoV-2-neutralising monoclonal antibodies (mAbs) — can emerge as one of the main treatments for mild COVID-19," Cadila Healthcare said in a regulatory filing.

Cadila Healthcare is the listed entity of the group.

At present, ZRC-3308 is found to be safe and well-tolerated in animal toxicology studies.

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Zydus said it is the only Indian company to have developed a neutralising monoclonal antibody-based cocktail for the treatment of COVID-19.

Dr 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-19. 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 safe treatment.”

Earlier this week, drug majors Roche India and Cipla announced the launch of Roche's Antibody Cocktail in India, priced at Rs 59,750 per dose for the treatment of mild to moderate COVID-19 in patients who are at high risk. 

The drug — developed by New York-based Regeneron Pharmaceuticals Inc. — comprises two antibodies casirivimab and imdevimab. An antibody cocktail is a mix of two or more unique biological drugs that act like human antibodies to help fight off infection.

Roche Pharma India will import the cocktail, which will be marketed and distributed through a strategic partnership with Cipla.

Cipla will sell the two-dose pack at Rs 119,500, the two companies said in a joint statement. The second batch will be made available by the middle of June.