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Zydus Cadila seeks DCGI nod for human clinical trials of its COVID antibody cocktail

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Ahmedabad-headquartered Zydus Cadila has approached regulators in India seeking permission to conduct clinical trials of its antibody cocktail for treating mild COVID-19 cases.

The company has sought permission from the Drugs Control General of India (DCGI) to initiate phase 1 of the three-phased human clinical trial.

The development comes at a time when the country is facing a second wave of the COVID-19 pandemic and while daily infections have declined, the death toll continues to remain a cause of concern.

What Zydus Cadila said

The company’s treatment candidate, ZRC-3308, had earlier shown to reduce lung damage during animal trials and it was found to be safe and well-tolerated. Notably, the therapy is a cocktail of two monoclonal antibodies, which mimic natural antibodies that the body generates to fight infection.

Cadila Healthcare said in an exchange filing said, “Zydus Cadila today announced that its biological therapy 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. SARS-CoV-2 spike protein targeted, neutralizing monoclonal antibody-based treatments have received emergency use authorization in mild COVID 19 in the US, Europe and India because they significantly reduced viral load in mild patients and their rate of hospitalization.”

Similar products already available

The US Food and Drug Administration (FDA) has given emergency use authorisations to similar treatments developed by Vir Biotechnology and GlaxoSmithKline, as well as ones made by Regeneron Pharmaceuticals and Eli Lilly.

Also Read: 6,515 oxygen and ICU beds in COVID facilities remain vacant in Ahmedabad

Regeneron and Roche’s antibody cocktail has also received emergency use approval in India. It will be distributed by drugmaker Cipla. The first batch of the cocktail became available in India earlier this week.

COVID-19 situation in India

The health ministry on Thursday informed that over 2.11 lakh fresh cases of COVID-19 have been reported in India in the past 24 hours. The addition of the fresh cases has taken the COVID-19 case tally past 2.73 crore.

Also, 3,847 COVID-19 related deaths were reported by the ministry during this period. The addition of the fresh fatalities has taken India’s death toll due to the deadly virus to 3,15,235.

 

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