Zydus Cadila seeks DCGI nod for human trial of antibody cocktail to treat COVID-19

Amidst the COVID-19 pandemic, on May 27, drugmaker, Zydus Cadila, informed that they sought regulatory approval from the Drugs Controller General of India (DCGI) to undertake clinical trials for monoclonal antibodies cocktail that can neutralise COVID-19 infection. The company's biological therapy ZRC-3308 which is a cocktail of two SARS-CoV-2-neutralizing monoclonal antibodies (mAbs) is potentially one of the main treatments for mild COVID-19. 

It is pertinent to note that SARS-CoV-2-neutralizing monoclonal antibody-based treatments have received emergency use authorization in mild COVID-19 in the US, Europe and India as they significantly reduce the viral multiplication and load in mild patients and their rate of hospitalisation.   

In a statement, Dr Sharvil Patel, Managing Director of Cadila Healthcare Limited affirmed their belief in "biological therapy" ZRC-3308 which has the potential to redress concerns as COVID-19 infection ascends in one's body.  

Speaking on its development Zydus Cadila's Managing Director, Sharvil Patel, said in a stock exchange filing, "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 patient's suffering and discomfort. we believe the ZRC-3308 has the potential to address these concerns and provide safe treatment." 

Zydus Cadila Confident of  ZRC-3308

In a press release, the pharmaceutical company said the ZRC-3308 is formulated to have a "long half-life providing protection for a long period of time" and has "reduced immune effector functions to minimize potential tissue-damaging side effects of virus-neutralizing monoclonal antibodies (mAbs) thereby providing a safer product".

Their statement to the press added, "Two of these products are cocktail-based products comprising of two mAbs binding to two different epitopes on the spike protein of SARS-CoV-2 virus. Cocktail of 2 mAbs based products is better equipped to deal with variants than single mAb based products which have a tendency of losing their efficacy with rapidly generating variants."

Cadila Healthcare Limited is an Indian multinational pharmaceutical company headquartered in Ahmedabad, Gujarat, India primarily engaged in the manufacture of generic drugs.