Botanix Pharmaceuticals has published positive data from a world-first human clinical study examining the safety, tolerability and efficacy of its synthetic CBD formulations for the eradication of Staphylococcus Aureus (Staph).
The BTX 1801 Phase 2a nasal decolonisation 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.
Eradication rates as high as 76.2% were obtained at Day 7 post treatment, with eradication effects extending through to Day 28 of the study to 23.8%, despite no further treatment after Day 5. Botanix met the endpoints of its BTX 1801 Phase 2a study.
Staph, also called golden staph, is a common bacterium that lives on the skin or in the nose. In most situations it is harmless, but if it enters the body through a cut in the skin, it can cause a range of mild to severe infections or even death.
As part of the study, Botanix was working 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 nose is frequently touched, usually more than 40 times a day).
Botanix president and executive chairman Vince Ippolito said: “We are very pleased to announce this top-line data that demonstrates synthetic cannabidiol 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.
“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.”
Botanix is now actively exploring opportunities for its synthetic cannabidiol and broader cannabinoid analog assets in other secondary infections, and across different routes of administration.