Hyderabad: VINS Bioproducts on Monday received approval from the Drugs Controller General of India (DCGI) to commence the clinical trials for VINCOV-19, an antidote, and a cure against COVID-19, the Hyderabad based immunological company said.
In a statement, VINS Bioproducts said that VINCOV-19, developed by VINS Bioproducts in collaboration with Centre for Cellular and Molecular Biology (CCMB) and the University of Hyderabad (UoH), as an antidote and a cure, is a significant step in the fight against coronavirus.
The clinical trials of VINCOV-19 will involve over 300 subjects spread across the country. The safety and efficacy of the antibodies will be examined in a group of around 300 patients, with COVID-19, informed the statement.
As per the statement, VINCOV-19, a new therapeutic product, is obtained after immunisation of horses with spike glycoprotein of the inactivated COVID virus. This results in the development of antibodies in the horses and the resultant antisera — the blood serum containing antibodies — is synthesised from the horse and can be injected into humans infected with Covid-19 to neutralise the virus.
It further stated that as part of development, the company selected the inactivated virus domain of the SARS-CoV-2 Spike protein as an immunogen. The results indicated that the product has a high neutralising capacity against SARS-CoV-2.
Since neutralising antibodies could block the internalisation of SARS-CoV-2 to lung cells, it was postulated that their passive administration should render maximal clinical benefits if they are applied at the early stages of the disease, it said.
Speaking on the commencement of the clinical trials, which have been approved by the DCGI, Siddharth Daga, Chief Executive Officer, VINS Bioproducts Limited said, "The development of VINCOV-19, in partnership with the Centre for Cellular and Molecular Biology and the University of Hyderabad and under the aegis of the Indian Council of Medical Research (ICMR), is a significant breakthrough in the fight against COVID-19. We feel extremely privileged that we have been able to use our collective resources and expertise in developing this cure and are proud to lead this fight against COVID-19."
It said that the clinical plan is to administer the hyperimmune serum to patients with moderate to severe disease according to the published COVID-19 treatment guidelines as soon as they are detected positive. This reinforces the idea that the therapeutic strategy, with equine antibodies, will play a significant role in managing COVID-19 and the ensuing pandemic.
As per the statement, the pre-clinical trials for VINCOV-19, which began in October 2020, were "very successful". VINS Bioproducts Limited produced F(ab')2 polyclonal antibodies that proved to have high neutralising capacity, it further said.