Australian company Biotron (ASX:BIT) has announced that all participants in the Phase 2 COVID-19 clinical trial of its antiviral drug BIT225 have completed dosing, marking the end of the clinical phase of the study.
It said preliminary results are expected to be available in September 2023.
The company said the design of the Phase 2, double-blind, placebo-controlled clinical trial (BIT225-012) was based on guidance received in 2022 from the US FDA.
It said the trial aims to determine if seven days of treatment with BIT225 commenced within three days of onset of COVID-19 symptoms results in a 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.
The company said BIT225 had shown very good activity against SARS‐CoV‐2 and prevented disease development in a COVID‐19 mouse model. BIT225 reduced levels of SARS‐CoV‐2 virus and stopped the life-threatening cytokine storm. It said BIT225‐treated mice did not develop any signs of disease and remained healthy throughout the several studies.
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.”