The Drug Controller General of India (DCGI) of the Central Drugs Standard Control Organization (CDSCO) has granted authorisation to advance the Phase III portion of Inovio’s international Phase II/III clinical trial for its Covid-19 vaccine candidate, INO-4800, in the country.
The vaccine contains a well-designed deoxyribonucleic acid (DNA) plasmid and is administered intradermally, following electroporation using a smart device.
This device can deliver the DNA plasmid into body cells to stimulate a well-tolerated immune response.
Inovio will carry out the Phase III INNOVATE trial in collaboration with Advaccine Biopharmaceuticals Suzhou in various countries in Latin America, Africa and Asia.
The Phase III trial will investigate the efficacy of two 2mg doses of INO-4800 given at a one-month interval in adult subjects aged 18 years and above.
Virologically established symptomatic Covid-19 will be the trial’s primary goal.
Inovio commenced Phase III trial in various other countries on obtaining favourable data from Phase II US trial.
INO-4800 was found to be well-tolerated and immunogenic in adults, interim data from the Phase II trial showed.
Inovio president and CEO Dr J Joseph Kim said: “As Covid-19 continues to threaten the health and safety of the global population, and many areas of the world are still awaiting sufficient access to safe and effective vaccines, Inovio is pleased to receive regulatory authorisation to proceed with our efficacy Phase III trial in India.
“Inovio remains steadfast in its mission to fight Covid-19 through the development of INO-4800, which is designed to serve the needs of those in India and beyond, as both a primary series and a booster vaccine.”
Inovio obtained Colombia’s National Food and Drug Surveillance Institute (INVIMA) authorisation to conduct the trial last month.
The company also received regulatory authorisation from health agencies in Brazil, the Philippines, and Mexico for the trial.