Akers Biosciences, Premas Biotech Announce SARS CoV-2 Positive Proof of Concept Results

Akers Biosciences announced with its partner, Premas Biotech, positive proof of concept results from Animal Studies conducted during a 4 week test of its SARS-CoV-2 vaccine candidate in mice. The test had two primary endpoints, safety and immune response, both of which were met. The candidate was well tolerated and safe in mice that received the intramuscular injection. A robust immune response was also observed.

The study consisted of 50 mice, divided into 10 cohorts dosed with 5, 10 and 20 micrograms of the PRAK-03202 vaccine candidate. The vaccine candidate was generally well tolerated and safe at all doses, with no adverse events reported. The vaccine candidate was safe even at higher doses and generated a robust immune response against the three SARS-Cov2 antigens, S, E, and M. PRAK3202 elicited neutralizing antibody titers levels in all the dose cohorts starting from 5 microgram to 20 microgram dose regimens. After three doses in mice, all the groups' cohorts showed binding antibody levels similar to convalescent patients’ levels.

“We are happy to report that the vaccine candidate study in mice has gone on well, and the results are positive and encouraging. We have engaged with the regulatory authorities in India and are working towards the next steps under their guidance,” Prabuddha Kundu, Co-Founder and Managing Director at Premas Biotech, said.

Premas will seek to further characterize the immune response in the near term, while pursuing additional safety studies and later stage animal testing with the goal of an investigational new drug (IND) submission to follow in the U.S. Premas continues to be engaged formally with authorities and the Drug Controller in India. Both Akers and Premas are also communicating with regulators in the United States.

“We are very encouraged by the immune response and safety milestones met in this study organized with our partner, Premas. We are currently moving towards enhanced dialogue with regulatory bodies in both India and the United States and look forward to communicating updates with our investors in the near term,” Christopher Schreiber, Executive Chairman of Akers, said.