New Delhi: Cadila Healthcare Ltd (Zydus Cadila) has sought permission from India’s drugs regulator for starting the next phase of human clinical trials for its biological therapy to treat mild Covid-19 cases.
On Thursday, the Ahmedabad-based company said the therapy named ZRC-3308, a cocktail of two SARS-CoV-2-neutralising monoclonal antibodies (mAbs), targets the SARS-CoV-2 spike protein.
It significantly reduces viral load in mild patients and their rate of hospitalization, said the company after seeking permission from the Drugs Controller General of India (DCGI) for phase 1 to 3 trials, according to reports.
Treatments similar to its product have received emergency use authorization (EUA) in mild Covid-19 patients in the US and Europe. Zydus is the only Indian company to have developed a neutralizing monoclonal antibody-based cocktail for the treatment of COVID 19.
“At this juncture, there is a critical need to explore safer and more efficacious treatments to combat Covid-19. It is important to look at different stages of the disease progression and at options that can reduce a patient’s suffering and discomfort. We believe that ZRC-3308 has the potential to address these concerns and provide safe treatment,” said Dr. Sharvil Patel, Managing Director.
The firm said its therapy could come in handy amid newer variants of the coronavirus ahead of a potential third wave of the pandemic in India. Cocktails of two monoclonal antibodies-based products are better equipped to deal with the new Covid-19 variants than single mAb based-products.
In animal studies, the ZRC-3308 therapy reduced damage to the lungs in both prophylactic and therapeutic settings. It was found safe and well-tolerated in animal toxicology studies.
(VP)