Biotron (ASX:BIT) has provided an update on the BIT225-012 Phase 2 clinical trial of its lead antiviral drug BIT225 for treating COVID-19.
The company said the trial met the primary safety and tolerability endpoint, with adverse events observed congruent in severity and frequency with those seen in previous trials of BIT225.
It said the trial did not meet the primary efficacy endpoint in this population, which was assessed by the change in SARS-CoV-2 nasal viral load.
“There were no statistically significant differences between drug and placebo groups based on change in SARS-CoV-2 nasal viral load, kinetics of change or time to negative SARS-CoV-2 PCR when compared to baseline values on Day 1 to dosing completion on Day 7,” said Biotron.
The company said that once the dataset was complete and unblinded, it was noted that four trial participants did not demonstrate quantifiable levels of nasal SARS-CoV-2 virus on Day 1. All participants had positive PCR on Day 1, but their levels of viral RNA were below the limits of quantification.
Biotron managing director Michelle Miller said, “We remain optimistic re the potential of this new class of drugs to target significant viral infections, including SARS-CoV-2. Our preclinical data in a mouse COVID-19 model that supported the BIT225-012 clinical study remain some the best in the field.
“Demonstrating efficacy of new drugs to treat this disease is difficult in small trials, conducted in people without high risk of progression to severe COVID, who are excluded from investigative, placebo-controlled trials. The widespread availability of vaccination as well as immunity due to prior infection with SARS-CoV-2 contribute to challenges in demonstrating clinical efficacy in these trials.
“Biotron remains focused on its platform of viroporin antagonists which uniquely combine direct-acting antiviral and immunomodulatory activities across numerous viruses responsible for important human disease. We would like to thank the principal investigators, trial sites, CROs, and most importantly, the trial participants who enrolled in the study.”
