Akston Biosciences, developer of new classes of biologic therapeutics, on Thursday announced that it has dosed first volunteers from India in Phase II/III Clinical Trial for its low cost, shelf stable protein subunit COVID-19 vaccine.
The Central Drugs Standard Control Organization (CDSCO) had approved the double-blind, placebo-controlled trial, initiated by Ahmedabad-based Veeda Clinical Research Limited, whose data will be submitted in an application for Emergency Use Authorization (EUA).
The multicenter trial will complete the enrollment of 1,500 healthy volunteers, age 18 and older, who will receive two 90 µg doses 28 days apart, the company stated.
Of the 1,500 healthy volunteers, 1,125 will receive the two-doses of vaccine, with the first dose including vaccine named AKS-452 and an adjuvant, which primes the body's immune response, while the second dose will consist only of AKS-452.
The remaining 375 volunteers will receive two doses of placebo with the first dose including placebo and the adjuvant, while the second dose will consist only of placebo. The primary objective of the study is to evaluate the safety, tolerability and humoral immunogenicity profile of AKS-452 at day 56, following a two-injection regimen in a combined bridging and a Phase II/III clinical study.
Interim results of the ongoing trial are expected to be available in June 2022. This follows a successful 100-volunteer open-label bridging study by Veeda, which began in November 2021.
A recent Phase II clinical trial conducted at the University Medical Centre Groningen (UMCG) in the Netherlands showed a robust 98% seroconversion response after either two 45 µg doses (100%) or a single 90 µg dose (96%) of AKS-452 in healthy adults at 56 days. It was well-tolerated with a safety profile comparable to approved vaccines.
Additional trials are also being pursued to qualify AKS-452 as a booster to itself or to other approved vaccines.
Akston recently signed a licensing, manufacturing and commercialization agreement with Strides Group subsidiary Biolexis. Under the agreement, Biolexis gains the right to manufacture and commercialize AKS-452, branded as AmbiVax-C in India, and over 130 countries in Asia, Latin America, and Africa, largely covering the low-and-middle-income countries (LMICs). The partnership will leverage the capabilities of Strides Group, a global pharmaceutical company headquartered in Bengaluru, India. Strides has an "in Africa for Africa" strategy and will offer the vaccine in countries where it has a deep market presence and established relationships.
"This clinical trial represents an important step in the development of protein-based COVID-19 vaccines. We are working closely with Strides Group, which will manufacture AKS-452 at scale, so that it can be quickly rolled out after receiving an EUA. We look forward to being able to supply the vaccine to countries that need an affordable and effective way to protect their populations during this worldwide pandemic," said Todd Zion, President and CEO of Akston Biosciences.
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