Zydus Cadila seeks DCGI nod for clinical trial of monoclonal antibodies cocktail that can neutralise COVID-19 infection

Zydus Cadila on Thursday said that it had sought DCGI approval to undertake clinical trials for a monoclonal antibodies cocktail that can neutralise COVID-19 infection.

"Zydus is currently seeking permission to initiate phase 1/3 human clinical trials from the DCGI... 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," Cadila Healthcare said in a regulatory filing.

With the product still at a testing stage, there is not much information yet about pricing or availability. Earlier this week however, the antibody combination of Casirivimab and Imdevimab became available in India to treat COVID-19 positive patients with mild or moderate symptoms before they deteriorate further or require hospitalisation. Manufactured by CIPLA, the price of each dose is Rs. 59,000. And according to officials one dose is usually enough.

On Wednesday, an 84-year-old COVID-19 patient was discharged from Gurugram's Medanta Hospital after having received the single-dose infusion-based treatment. He became the first patient in India to receive monoclonal antibody therapy.

Simply put, a monoclonal antibodies cocktail is a combination that mimics the he immune system's ability to fight off viruses and other harmful pathogens. Popular in the US for some time now, this had been used to treat former President Donald Trump when he had tested positive for COVID-19 in 2020. In the case of the Cipla-Roche cocktail, it is projected to stave off hospitalisation for around 70 to 80% of people. Doctors say that the antibodies are also effective against the new variant B.1.617.2.

"If these antibodies are injected into a patient infected with COVID-19 virus at an early stage when the virus is trying to multiply then it blocks the virus from entering the cells of the patient from where it derives nutrition to multiply. So by blocking the virus they are stopping the multiplication of the virus and finally the virus spikes. It is one of the blocking mechanisms that is working against the COVID-19 virus," Dr Naresh Trehan, the Chairman of Medanta Hospitals told ANI.

The antibody cocktail therapy is not recommended for patients who are hospitalized due to severe COVID-19, or those who require oxygen therapy due to COVID-19 or who require an increase in baseline oxygen flow rate due to the disease and in patients on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

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