In March 2022 the Company submitted a proposal to the USA Food and Drug Administration (FDA) to conduct a human clinical trial to assess the efficacy of BIT225 for the treatment of COVID-19 under the Coronavirus Treatment Acceleration Program, a special emergency program for potential coronavirus therapies.
30 May 2022 Ann:
POSITIVE FDA GUIDANCE FOR COVID-19 CLINICAL PROGRAM
The Directors are pleased to advise that Biotron Limited (‘Biotron’ or ‘the Company’
has received guidance from the U.S. Food and Drug Administrations (‘FDA’
for development of its lead antiviral drug BIT225 as a potential treatment of Coronavirus Disease 2019 (COVID-19) infection in adults.
The FDA’s guidance was received in written response to Biotron’s pre-IND briefing package and request in March 2022, which included an overview of preclinical and (HIV) clinical development, and specific questions relating to regulatory requirements for progression to filing an investigational new drug (‘IND’
application for the COVID-19 indication.
Biotron’s Managing Director, Dr Michelle Miller, said:
“
The FDA responses were constructive, highly informative, and provide direction in the design of the proposed Phase 2 clinical trial. The recommendations for a small, placebo-controlled, proof-ofconcept, dose-finding study, with agreed end points, in line with studies for other respiratory diseases, including influenza, are very welcome. This design is de-risking and will provide the Company with important time and resource savings."
"The FDA responses indicate that we are on the right path to the clinic. Our confidence levels for this new class of anti-SARS-Cov-2 drug remain high.”The FDA response gives clear indication of the Agency’s interest in this novel drug target that combines direct antiviral effect and beneficial immunomodulatory activities.
