Indian pharma Zydus Cadila seeks human trial approval for antibody cocktail
India's pharma major Zydus Cadila has said it is seeking permission from the Drugs Controller General of India (DCGI) to initiate human clinical trials for monoclonal antibodies cocktail which treats mild to moderate Covid-19.
"Zydus is currently seeking permission to initiate phase 1/3 human clinical trials from the DCGI. ZRC-3308, a cocktail of two SARS-CoV-2-neutralizing monoclonal antibodies (mAbs) can emerge as one of the main treatments for mild Covid-19," Cadila Healthcare said in a regulatory filing, our New Delhi correspondent reports.
Cadila Healthcare, based in Ahmedabad, is the listed entity of the group.
ZRC-3308 was safe and well-tolerated in animal toxicology studies, said the company.
Zydus said it is the only Indian company to have developed a neutralizing monoclonal antibody-based cocktail for the treatment of Covid-19.
Sharvil Patel, Managing Director, Cadila Healthcare Ltd, said, "There is a critical need at this juncture 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 the patient's suffering and discomfort.
"We believe that ZRC-3308 has the potential to address these concerns and provide a 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.
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