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 sought guidance on the design of a proposed Phase 2 clinical trial in recently diagnosed COVID-19 infected individuals and assurance that the preclinical data package and manufacturing processes were sufficient to support this next stage of clinical development.

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-of- concept, 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 feedback on the existing supporting non-clinical studies and the manufacturing processes, specification and composition of the drug product was positive.

The design of regulatory-quality clinical studies for SARS-CoV-2 therapeutic advancement during this currently evolving disease and treatment landscape, requires careful consideration. We now have a clear directive for the design of a Phase 2 study. This guidance will inform the on-going development of BIT225 and subsequent next-generation follow-on drugs in Biotron’s portfolio.

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.”