Strides Pharma announced on June 24 results from a Phase II/III clinical trial in India of the SARS-CoV-2 vaccine, AKS-452, in which 1,600 healthy volunteers participated – 100 in an open-label bridging study and 1,500 in Phase II/III, double-blind, placebo-controlled trial.
The company said in an exchange filling that a preliminary review of this data reveals the vaccine was well tolerated with no significant safety concerns and a seroconversion rate of 91% at Day 56.
The Strides Pharma stock traded at Rs 327 on BSE - up more than 4 percent - at the time of writing this copy.
Furthermore, in the bridging trial, volunteers exhibited antibody titers that remained statistically significant high levels for six months, and serum samples taken from them demonstrated protection against variants of concern.
The findings will be submitted to India for Emergency Use Authorization (EUA) as a primary vaccination . Later clinical studies will be conducted to justify the vaccine's usage as a booster shot for other licenced vaccinations and for itself.
It is to be noted that previous studies in the Netherlands have demonstrated robust antibody neutralisation of variants, including Delta and Omicron.
Arun Kumar, Founder of Strides Group, said, “We are pleased to know the encouraging results from the India studies of AmbiVax-CTM, particularly the high seroconversion rate that the Vaccine demonstrated. This vaccine differentiates itself by allowing room-temperature stability, higher efficacy, and safety and can offer accessibility and affordability through the economical supply chain and infrastructure requirements. As we progress to receiving the approval, we will continue exploring opportunities to fast-track its launch for the global markets.”
Akston Biosciences Corporation and Biolexis, a Strides Group Company, in collaboration, announced encouraging top-line results from phase II/III trial of their thermostable 2nd Gen COVID-19 vaccine.
Both the companies have already signed a licensing, manufacturing, and commercialisation agreement to launch this vaccine worldwide as AmbiVax-C(TM).
Todd Zion, Ph.D., President & CEO of Akston Biosciences, said, “The latest clinical data demonstrate the potential of this low-cost protein vaccine intended specifically for those most in need. We are very pleased to be working closely with Biolexis and Strides Group, which can supply the vaccine at scale to countries that need a practical and affordable way to protect their populations during this worldwide pandemic.