Ann: POSITIVE FDA GUIDANCE FOR COVID-19 CLINICAL PROGRAM, page-5

Level 2, 66 Hunter Street
Sydney NSW 2000
Tel: (61-2) 9300 3344
Fax: (61-2) 9221 6333
E-mail: [email protected]
Website: www.biotron.com.au
30 May 2022
The Manager Companies
ASX Limited
20 Bridge Street
SYDNEY NSW 2000 (2 pages by email)
Dear Madam
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 respons e to Biotron’s pre-IND briefing package and
request in March 2022, which include d an overview of preclinical a nd (HIV) clinical development,
and specific questions relating to re gulatory requirements for progressi on 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 recommenda tions 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 sup porting 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, re quires careful considerat ion. 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.”