Zydus seeks human trial approval for its COVID-19 antibody cocktail
Indian pharmaceutical firm Zydus Cadila has sought permission from the Drugs Controller General of India (DCGI) to conduct human clinical trials of its antibody cocktail meant to treat mild COVID-19 patients. The move holds significance as the country is running seriously short on the supplies of drugs and vaccines against the coronavirus amid a devastating second wave of the pandemic.
What is an antibody-based cocktail?
Zydus is the only Indian company to have developed an antibody-based cocktail for the treatment of COVID-19 cases. Neutralizing monoclonal antibodies are laboratory-made proteins, that mimic our immune system's ability to generate natural antibodies to fight off an infection. The candidate, called ZRC-3308, contains two monoclonal antibodies and can significantly reduce viral load in mild patients and their chances of hospitalization, the firm said.
ZRC-3308 reduces the risk of severe disease: Zydus
The company has sought permission to carry out Phase 1/3 human clinical trials from the DCGI, it said. In animal studies, the ZRC-3308 helped reduce damage to the lungs and was also found to be safe, it added. Zydus further said it would provide protection for a longer period of time as compared to the currently approved products.
'Critical to explore safer, efficient treatments for COVID-19'
"At this juncture, there is a critical need to explore safer and more efficacious treatments to combat COVID," said Sharvil Patel, the Managing Director of Cadila Healthcare. "It is important to look at different stages of the disease progression and look at options that can reduce a patient's suffering and discomfort. We believe that ZRC-3308 has the potential to address these concerns."
Similar treatments already approved in the US, Europe
Similar antibody-based treatment methods have already been approved by drug regulators in the United States. The companies granted permission there include Vir Biotechnology and GlaxoSmithKline as well as Regeneron Pharmaceuticals and Eli Lilly. In fact, an antibody cocktail from Regeneron and Roche also recently received approval in India and will be distributed by the drug maker Cipla.
India's deadly second wave marred by drug shortages
India has been severely affected by a second wave of the coronavirus - in the past 24 hours alone, the country logged 2.11 lakh fresh COVID-19 infections and over 3,800 deaths. Daily cases in India had peaked at 4,14,000 earlier this month. The nation's handling of the deadly wave has been marred by acute shortages of drugs and vaccines, drawing criticism, locally and internationally.
