Biotron Limited (ASX: BIT) provided an update on the BIT225-012 Phase 2 clinical trial of its lead antiviral drug BIT225 for treating COVID-19. The trial not only successfully met the primary safety and tolerability endpoint, but did so with a thoroughness that reassures: adverse events were consistent in severity and frequency with those seen in previous trials of BIT225.
There were no statistically significant differences between the drug and placebo groups in terms of the change in SARS-CoV-2 nasal viral load, kinetics of change, or time to negative SARS-CoV-2 PCR compared to baseline values from Day 1 to dosing completion on Day 7. The groups were similar regarding time to sustained clinical recovery and time to clinical improvement. The timeframe for the primary efficacy analyses was from Day 1 to Day 7, as pre-specified in the Statistical Analysis Plan. Analyses were performed using Good Clinical Practice and international regulatory requirements.
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