Hyderabad: City-based firm Vins Bioproducts Limited on 27 April announced that it has received approval from the Drugs Controller General of India (DGCI) to start clinical trials for its COVID-19 antidote VINCOVIN-19.
The antidote was developed in collaboration with the University of Hyderabad and CSIR-Centre for Cellular and Molecular Biology (CSIR-CCMB). The pre-clinical trials for VINCOV-19, which began in October 2020, were highly successful, showing potent virus-neutralizing capability.
VINCOV-19 is an antibody fragment-based (Fab2) product that retains virus binding sites. It is obtained after immunization of horses with inactivated SARS-CoV-2 virus in combination with adjuvants. This triggers the development of antibodies in the horses, which is purified and further proteolytically processed to generate highly pure F(ab') 2 as a finished product. The results indicated that this product has a high neutralizing capacity against SARS-CoV-2. Since neutralizing antibodies could block the internalization of SARS-CoV-2 to lung cells, it is postulated that their passive administration should render maximal clinical benefits if they are applied at the early stages of the disease.
The clinical trials for 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. The clinical plan is to administer VINCOV-19 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.
Siddharth Daga, the CEO of Vins Bioproducts, is confident that they will be able to bring out the product to the market soon after the clinical trials.
On 24 April, Hyderabad-based pharmaceutical company Biological E. Limited had received approval from the Central Drugs Standard Control Organization to start phase III clinical trials of its COVID-19 vaccine candidate.