VINCOV-19, India’s first antidote and potential cure against COVID-19, is now ready for market authorisation and for simultaneous Phase 3 Clinical Trials. The Hyderabad University and the Centre for Cellular and Molecular Biology (CCMB) in collaboration with VINS Bioproducts Limited announced the successful completion of the Phase 2 Clinical Trials of VINCOV-19 on Tuesday.
According to a statement issued by the varsity, the Phase 2 Clinical Trials were conducted across multiple centres in India and included over 200 patients. Moreover, 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.
“Phase 2 Clinical Trials were completed successfully in September 2022. In this phase, 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 University said in a statement on Tuesday.
The antidote, VINCOV-19, contains Equine polyclonal antibodies (EpAbs) against the COVID-19 virus. According to the scientists, VINCOV-19 comprises highly purified F(ab’)2 antibody fragments that have a high neutralizing capacity against the SARS-CoV-2 virus.
Since neutralising 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 scientists claim.
“We are very proud of the highly successful collaboration between VINS, CCMB, and UoH. 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 targeted collaborations between academia and industry,” Dr. Vinay K. Nandicoori, Director, CSIR-Centre for Cellular and Molecular Biology (CCMB), Hyderabad, said in a statement on Tuesday.
The development of the antidote is through a collaborative effort between the Centre for Cellular and Molecular Biology (CCMB) developed the viral antigen; the university helped with product characterisation; and VINS Bioproducts Limited managed the equine immunization and clinical development in their state-of-art manufacturing plant in Telangana.
ALSO READ | AstraZeneca’s nasal COVID-19 vaccine fails clinical trial
