HYDERABAD: Immunologicals player VINS Bioproducts Ltd on Monday said it has received approval from the Drugs Controller General of India (DCGI) for conducting clinical trials of its Covid-19 antidote VINCOV-19.
The phase I and II trials for VINCOV-19, developed in collaboration with the Centre for Cellular and Molecular Biology (CCMB) and the University of Hyderabad (UoH), will be conducted on around 300 volunteers nationwide at three hospitals across the country. One hospital each will be selected in the north, south and in Mumbai in the west zone, VINS Bioproducts CEO Siddharth Daga told TOI.
The company said that the pre-clinical trials of VINCOV-19, which commenced in October 2020 and were conducted on rodents and non-rodents, were successful. It was able to produce F(ab’)2 polyclonal antibodies that showed high Covid-19 neutralising capacity. “The toxicity and pharmacokinetics studies were conducted at CCMB’s lab,” he said.
VINCOV-19 was developed by immunising horses with the spike glycoprotein of the inactivated SARS-CoV-2 virus and then synthesising the antisera (blood serum containing antibodies) obtained from the immunised horses. The antisera is to be injected into humans infected with Covid-19 to neutralise the virus.
“The safety and efficacy of the antibodies will be examined in a group of around 300 Covid-19 patients. The clinical plan is to administer this hyperimmune serum to patients with moderate to severe disease according to the published Covid-19 treatment guidelines as soon as they are detected positive,” the company said.