COMPLETION OF PHASE 2 COVID CLINICAL TRIAL The Directors of...

COMPLETION OF PHASE 2 COVID CLINICAL TRIAL
The Directors of Biotron Limited (‘Biotron’ or ‘the Company’ are pleased to advise that all participants
in the Phase 2 COVID-19 clinical trial of the Company’s antiviral drug BIT225 have completed dosing, marking the end of the clinical phase of the study.

As previously advised, the design of the Phase 2, double blind, placebo-controlled clinical trial
(BIT225-012) was based on guidance received during 2022 from the US Food and Drug Administration (FDA).

The trial aims to determine if 7 days of treatment with BIT225 commenced within 3 days of onset of COVID-19 symptoms results in reduction in SARS-CoV-2 blood viral load,
clinically favourable changes in viral, inflammatory and immune activation markers,
as well as improvement in clinical symptoms of COVID-19.

BIT225 has shown very good activity against SARS‐CoV‐2 and prevented development of disease in a COVID‐19 mouse model (ASX announcements 25 November 2021, 17 March 2022 and 2 May 2022). BIT225 reduced levels of SARS‐CoV‐2 virus and stopped the life‐ threatening cytokine storm.
BIT225‐treated mice did not develop any signs of disease and remained healthy throughout the several studies that were conducted.

Biotron’s Managing Director, Michelle Miller said, “We are very pleased to have completed recruitment and dosing in this important Phase 2 COVID trial. The trial commenced in May 2023 and its completion in just three months is a remarkable achievement, reflecting the quality and expertise of the principal investigators, trial sites, staff and contractors.”
Focus is now on the laboratory analyses of samples collected during the trial.

Preliminary results are expected to be available in September 2023.