Akston Biosciences Doses First Volunteers in Phase II/III Clinical Trial of Low Cost, Shelf Stable COVID-19 Vaccine

• 1,500 healthy volunteers to participate in a Phase II/III double-blind placebo-controlled study in India
• Study results to be submitted for Emergency Use Authorization (EUA)
• Vaccine is shelf stable for over six months at room temperature at 25° Celsius (77° Fahrenheit) and maintains potency for one month at 37° Celsius (99° Fahrenheit)

Excerpt from the Press Release:

BEVERLY, Mass. & BANGALORE, India–(BUSINESS WIRE)–Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today that the first volunteers in a Phase II/III clinical study of AKS-452, its low cost, shelf stable protein subunit COVID-19 vaccine, were dosed in India. India’s Central Drugs Standard Control Organization (CDSCO) 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. Under the supervision of six principal investigators (Pravin Dinkar Supe, M.D.; Krishna Giri, M.D.; Himanshu Pophale, M.D.; Prakash Shinde, M.D.; Shrikant Deshpande, M.D.; and Kuntal Shah, M.D.), the dosing of healthy volunteers will be completed by April 15, 2022.

Of the 1,500 healthy volunteers, 1,125 will receive the two-doses of vaccine, with the first dose including 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 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 (i.e., SP/RBD-specific IgG titers) 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 Phase II/III trial in India are expected to be available in June 2022. This follows a successful 100-volunteer open-label bridging study by Veeda, which began in Nov. 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.

Click the button below to read the entire Press Release:

Continue Reading The Press Release