Hyderabad: The phase 3 clinical trial of the first antidote against COVID, VINCOV-19, is expected to begin soon as the drug is ready for market authorization. VINCOV-19 is a joint effort of the University of Hyderabad (UoH), the Centre for Cellular and Molecular Biology (CCMB) and VINS Bioproducts Limited.
The phase 2 clinical trial of the drug in over 200 participants was done in September 2022. “Phase 2 Clinical Trials were conducted across multiple centres in India and included over 200 patients. The Phase 2 Clinical Trials also included testing the antidote against the Omicron variant to ensure maximum coverage against the virus and its known mutations,” says an official statement from UoH emphasizing on the need to tackle the Omicron variant.
Recently, a new sub variant of the Omicron variant has caught the attention of health agencies. The BF.7 sub variant of Omicron is currently being seen as a potential spreader due to high transmission rate and its ability to evade immunity. The BF.7 variant accounts for more than 25% of active COVID cases globally.
“VINCOV-19 was administered to patients with moderate severity of COVID-19. One group of patients was given VINCOV-19, along with Standard of Care (SoC), and another group was given Standard of Care (SoC) only. VINCOV-19 showed an excellent safety profile in the Phase 2 Trials. There was a good and early improvement in the clinical condition of the patients administered VINCOV-19,” the drug developers have said on the phase 2 clinical trial.
VINCOV -19 contains Equine polyclonal antibodies (EpAbs). “VINCOV-19 comprises highly purified F(ab’)2 antibody fragments that have a high neutralizing capacity against the SARS-CoV-2 virus. Since neutralizing antibodies could block the internalization 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,” the researchers explain.