- Biotron (BIT) receives positive US FDA guidance for its lead antiviral drug, BIT225, as a potential treatment of COVID-19
- The guidance follows the company sending a briefing package for a proposed phase two clinical trial
- Managing Director Michelle Miller says the FDA responses “were constructive, highly informative and provide direction” for the planned clinical trial
- Biotron will now look at funding options for the trial including capital from potential partners and non-equity funding sources
- BIT shares are down 10 per cent and trading at 9 cents each at 11:13 pm AEST
Biotron (BIT) has received positive US Food and Drug Administration (FDA) guidance for its lead antiviral drug, BIT225, as a potential treatment of COVID-19.
The guidance follows the company sending a briefing package in March about its proposed phase two clinical trial.
According to the company, the FDA response offers a clear indication that it’s interested in the novel drug target.
Last year, BIT225 showed it was effective in treating animals with a reduction of the virus in the blood.
Managing Director Michelle Miller said the FDA’s responses “were constructive, highly informative and provide direction” of the proposed phase two clinical trial.
“The recommendations 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,” she said.
“This design is de-risking and will provide the company with important time and resource savings.”
Dr Miller said that the FDA response indicates that Biotron is on the right path to the clinic.
“Our confidence levels for this new class of anti-SARS-Cov-2 drug remain high,” she added.
Biotron will now look at funding options for the trial including capital from potential partners and non-equity funding sources.
On the market, BIT shares were down 10 per cent and trading at 9 cents each at 12:13 pm AEST.