Positive study result for Botanix's BTX 1801 in golden staph

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Clinical stage synthetic cannabinoid company Botanix Pharmaceuticals (ASX:BOT) has published positive data from a human clinical study examining the safety, tolerability and efficacy of its BTX 1801 antimicrobial product for the eradication of Staphylococcus Aureus (Staph).

Staph, which is also called golden staph, is a common bacterium that lives on the skin or in the nose. In most situations it is harmless. However, if it enters the body through a cut in the skin, it can cause a range of mild to severe infections.

Botanix said that as part of the study, it was testing the ability of BTX 1801 to minimise the risk of infection by removing or decolonising bacteria from the nose – a primary site for spreading infection to other parts of the body.

The company said the proof of concept study showed that two different BTX 1801 synthetic CBD formulations (ointment and gel) were safe, well-tolerated and successful at eradicating staph bacteria from the nose of healthy volunteers nasally colonised with staph.

It said eradication rates as high as 76. per cent were obtained at day seven post-treatment, with eradication effects extending through to day 28 of the study to 23.8 per cent, despite no further treatment after day five. 

“We are very pleased to announce this top-line data that demonstrates synthetic cannabidiol ('CBD') is a safe and effective nasal decolonisation agent.  Moreover, this is the first time that synthetic CBD has been shown to have clinical utility as an antimicrobial agent in humans,” said Botanix president and executive chairman, Vince Ippolito.

“These results support continued development of BTX 1801 for the treatment of a variety of infections, in addition to the prevention of post-surgical infections.”

“BTX 1801’s observed upfront eradication rates and sustained eradication effect, following the treatment period, is very encouraging.  Data from the BTX 1801 study represents a significant milestone and enhances the potential of better infection prevention measures in surgical settings to combat the growing global development of antibiotic resistance,” said Murdoch University’s chair of Public Health, Professor Geoffrey Coombs.

Botanix said it is now actively exploring opportunities for its synthetic cannabidiol and broader cannabinoid analog assets in other secondary infections and across different routes of administration.