Zydus Cadila seeks permission from DCGI to test COVID-19 antibody cocktail on humans
Neutralizing monoclonal antibody-based treatments have received emergency use authorization in mild COVID-19 treatment
Cadila Healthcare (Zydus Cadila) has sought permission from the Drug Controller General of India (DCGI) to undertake human testing of its novel monoclonal antibody cocktail that can neutralize COVID-19 infection.
Zydus said the monoclonal antibody cocktail ZRC-3308 has been found to be safe and well-tolerated in animal toxicology studies and has demonstrated the ability to neutralise SARS-CoV-2 both in vitro and in animal studies.
"In animal studies, ZRC-3308 reduced damage to the lungs in both prophylactic and therapeutic settings," the company said in a statement quoted in multiple news reports.
Zydus is currently seeking permission to initiate phase 1/3 human clinical trials from the DCGI.
ZRC-3308 consists of two monoclonal antibodies to combat mild COVID 19 and is designed to have a long half-life providing protection for a long period of time.
The antibody cocktail is better equipped to deal with variants than the single antibody product and in animal studies, ZRC-3308 reduced the SARS-CoV-2-mediated damage to the lungs. The company said the drug has reduced immune-effector functions to minimize potential tissue-damaging side effects of virus neutralizing monoclonal antibodies thereby providing a safer product.
Monoclonal antibodies are emerging as important tools in the fight against COVID-19. The monoclonal antibodies act like natural antibodies by binding and destroying SARS-CoV-2 spike protein.
Neutralizing monoclonal antibody-based treatments have received emergency use authorization in mild COVID-19 in the US, Europe and India because they significantly reduce viral load in mild patients and their rate of hospitalisation.
On Wednesday, an 84-year-old man was administered with a drug cocktail of two fast acting antibodies, Casirivimab and Imdevimab, at Medanta Hospital in Gurgaon, Haryana. He became the first in India to be administered an antibody cocktail.
The first batch of the antibody cocktail drug manufactured by Roche had arrived in the country on Monday, according to an official announcement by Roche India and Cipla Limited, which is distributing the drug in India.
"If these antibodies are injected into a patient infected with the 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," Chairman and MD of Medanta hospital Naresh Trehan told ANI.
Dr Trehan further said that the antibodies are also effective against the new variant B.1.617.2 and this has been verified in laboratories as well.