New Delhi: Zydus Cadila on Thursday said it is seeking permission from Drugs Controller General of India (DCGI) to initiate human clinical trials for monoclonal antibodies cocktail for treatment of 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.
Cadila Healthcare is the listed entity of the group. ZRC-3308 has been found to be safe and well tolerated in animal toxicology studies. Zydus said it is the only Indian company to have developed a neutralizing monoclonal antibody based cocktail for the treatment of COVID-19.
Dr Sharvil Patel, Managing Director, Cadila Healthcare said, “At this juncture, there is a critical need to explore safer and more efficacious treatments to combat COVID. It is important to look at different stages of the disease progression and look at options that can reduce patient’s suffering and discomfort.
Dr Patel, said they believe that ‘biological therapy’ ZRC-3308 – ‘a cocktail of two SARS-CoV-2-neutralizing monoclonal antibodies (mAbs)’, has the potential to address concerns about the progression of the disease. “We believe that ZRC-3308 has the potential to address these concerns and provide a safe treatment,” he said.
In a press release, the pharmaceutical company said the ZRC-3308 is designed to have a “long half-life providing protection for a long period of time” and has “reduced immune-effector functions to minimize potential tissue-damaging side effects of virus neutralizing monoclonal antibodies thereby providing a safer product”.
“Two of these products are cocktail-based products comprising of two mAbs binding to two different epitopes on the spike protein of SARS-CoV-2 virus. Cocktail of 2 mAbs based products are better equipped to deal with variants than single mAb based products which have a tendency of losing their efficacy with rapidly generating variants,” it added.
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.
(With inputs from PTI)