VINS Bioproducts, in collaboration with the Centre for Cellular and Molecular Biology (CCMB) and the University of Hyderabad (UoH), has completed the phase-II clinical trial for VINCOV-19, an antidote and cure for COVID-19, a statement from VINS Bioproducts has claimed.
According to the statement, VINCOV-19 is now ready for market authorisation and for simultaneous phase-III clinical trials.
The phase-II clinical trials were conducted across multiple centres in India and included more than 200 patients. These also included testing the antidote against the Omicron variant to ensure maximum coverage against the virus and its known mutations, informed the statement.
During the phase-II clinical trials that were completed last month, 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 excellent safety profile in the phase-II trials. There was a good and early improvement in the clinical condition of the patients administered VINCOV-19, the statement added.
It also said that VINCOV-19 contains Equine polyclonal antibodies (EpAbs) against the COVID-19 virus. VINCOV-19 comprises highly purified F(ab’)2 antibody fragments that have a high neutralising capacity against the SARS-CoV-2 virus. 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.
Dr Vinay K Nandicoori, Director, CSIR-Centre for Cellular and Molecular Biology (CCMB), Hyderabad, said in the statement, “…..These therapeutic antibodies are the first in India, and among the few around the globe. It is essential to have multiple options, including therapeutic antibodies, especially for severe clinical cases of COVID. It is a major step for the future-targetted collaborations between academia and industry.”