Zydus Cadila seeks regulator nod for clinical trials on Covid-19 therapy

Company says product helps treating mild coronavirus patients and reduces hospitalisation.

Cadila Healthcare 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.

The company on Thursday said that the therapy named ZRC-3308, which is a cocktail of two SARS-CoV-2-neutralising monoclonal antibodies (mAbs), targets SARS-CoV-2 spike protein. It significantly reduces viral load in mild patients and their rate of hospitalisation, said the company after seeking permission from Drugs Controller General of India (DCGI) for phase 1 to 3 trials.

Zydus said treatments similar to its product have received emergency use authorisation in mild Covid-19 patients in the US and Europe. Zydus said it 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. 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 and provide a safe treatment," said Dr Sharvil Patel, managing director of Cadila Healthcare.

Zydus said its therapy could come 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 to be safe and well tolerated in animal toxicology studies.