The University of Hyderabad (UoH), CSIR-Centre for Cellular and Molecular Biology (CCMB) and VINS Bioproducts Limited together announced the successful completion of Phase-2 clinical trials of VINCOV-19, “India’s first antidote and a cure against SARS-CoV-2 virus.”
VINCOV-19 is ready for market authorization and simultaneous Phase 3 clinical trials, the researchers said on Tuesday.
“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-19,” Dr Vinay Nandicoori, Director, CSIR-CCMB, said.
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Phase 2 clinical trials were conducted across multiple centres in the country on over 200 patients. It included testing of the antidotes against the Omicron variant to ensure maximum coverage against the virus and its known mutations.
In the trials, completed in September, 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 these trials. There was a good and early improvement in the clinical condition of the patients administered VINCOV-19,” the researchers said in a joint statement.
VINCOV-19 contains Equine polyclonal antibodies (EpAbs) against the Covid-19 virus. It 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, a University of Hyderabad statement said.
Development of VINCOV-19 is a collaborative effort between the three Hyderabad-based bodies—CCMB that helped develop the viral antigen; University of Hyderabad, which helped with product characterization; and VINS Bioproducts Limited that managed the equine immunization and clinical development in their state-of-art manufacturing plant in Telangana.
VINS Bioproducts Limited is an immunological company based in Hyderabad, pioneering in equine immunoglobulins.