Zydus Cadila | Zydus Cadila ZRC-3308 Antibody Cocktail Gets SEC Green Light for Clinical Trials to Treat COVID-19

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Highlights

  • Zydus Cadila claims to have developed a cocktail based on neutralizing monoclonal antibodies (mAbs)
  • SEC issues recommendation for phase I and II clinical trials of Zydus Cadila ZRC-3308 biologic therapy
  • These antibodies are made by cloning single white blood cells

New Delhi: Zydus Cadila has been cleared to conduct clinical trials of its antibody-based cocktail (mAbs) for the treatment of COVID-19 by the Subject Matter Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) , according to sources.

Zydus Cadila is the only Indian company that claims to have developed a neutralizing monoclonal antibody (mAbs) cocktail for the treatment of coronavirus by cloning single white blood cells.

“The SEC gives a recommendation for phase I and II clinical trials of the biological therapy of Zydus Cadila ZRC-3308, a cocktail of two monoclonal antibodies neutralizing SARS-CoV-2 (mAb) that may emerge as one of the main treatments for mild COVID -19, “the sources told ANI.

Zydus Cadila Seeks DCGI Approval to Undertake ZRC-3308 Clinical Trials

The national pharmaceutical major recently applied to the Drug Controller General of India (DCGI) for authorization to undertake clinical trials, claiming that its biologic therapy ZRC-3308, a cocktail of two monoclonal antibodies neutralizing SARS-CoV-2 (mAb ) may emerge as one of the main treatments for mild COVID-19.

Few hospitals administer the cocktail of two fast-acting antibodies – Casirivimab and Imdevimab while the batch of the drug Roche Antibody Cocktail arrived in the country on May 24 with the cost of a single cocktail of antibodies at Rs 59,750.

Eli Lilly and Company is another antibody cocktail that has received clearance for restricted emergency use of its antibody-based drugs, bamlanivimab 700 mg and etesevimab 1400 mg, in India for the treatment of patients with mild to moderate coronavirus disease.

What are Antibody Cocktails?

A combination of two antibodies made in the laboratory, antibody cocktails are designed to block the binding of the virus to human cells and block its entry into the body. The cocktail is also effective against the spread of the COVID-19 virus and its different variants. When injected, it mimics the immune system to protect the human body from dangerous pathogens.

Once the virus enters the patient’s cells, they feed on them to multiply further. This is where the cocktail of antibodies comes in. When injected into patients with early-stage coronavirus, these antibodies prevent the virus from entering cells.


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