Zydus Cadila seeks DCGI approval for clinical trials for monoclonal antibodies cocktail to neutralise COVID infection
Zydus Cadila has sought approval from the Drugs Controller General of India (DCGI) to undertake clinical trials for monoclonal antibodies cocktail that can neutralise COVID-19 infection, the pharmaceutical manufacturer informed on Thursday.
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New Delhi: Zydus Cadila has sought approval from the Drugs Controller General of India (DCGI) to undertake clinical trials for monoclonal antibodies cocktail that can neutralise COVID-19 infection, the pharmaceutical manufacturer informed on Thursday.
In a statement, Dr Sharvil Patel, Managing Director of Cadila Healthcare Limited, 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.
"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 disease progression and look at options that can reduce patients suffering and discomfort," the statement, tweeted by the company said.
It added, "We believe that ZRC-3308 has the potential to address these concerns and provide a safe treatment."
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. (ANI)