- Botanix Pharmaceuticals (BOT) has launched the second phase of its BTX 1801 clinical study for the prevention of surgical site infections (SSIs)
- Roughly 80 per cent of SSIs are caused by the patient infecting themselves from their own nose where the bacteria can colonise
- Unfortunately, antibiotics used for nasal decolonisation have become more and more resistant
- Synthetic cannabidiol has been shown to effectively kill this bacteria
- These findings support the company's BTX 1801 antimicrobial gel as ideal for preventing SSIs
- The phase 2 study will evaluate this and first participants are expected to be enrolled early next quarter
- Company shares remain flat and are trading for 7 cents each
Botanix Pharmaceuticals (BOT) has launched the second phase of its BTX 1801 clinical study for the prevention of surgical site infections (SSIs).
One of the most troublesome resistance forming bacteria in the world is Staphylococcus aureus (Staph). Particularly, Methicillin-resistant Staphylococcus aureus (MRSA) is becoming a significant global concern.
Staph and MRSA are the number one cause of SSIs and roughly 80 per cent of SSIs are caused by the patient infecting themselves from their own nose where these bacteria can colonise.
Unfortunately, antibiotics used for nasal decolonisation have become increasingly resistant, with some hospitals recording resistance rates of up to 95 per cent.
In fact, patients colonised with Staph at intensive care unit admission, had an up to 15 times increased risk for developing pneumonia compared to non-colonised patients.
"Antibiotic resistance continues to be a significant global health issue, with no new classes of antibiotics receiving FDA approval in more than three decades, despite the availability of significant funding initiatives and regulatory incentives," Botanix Executive Chairman and President Vince Ippolito said.
Botanix's BTX 1801 antimicrobial gel has shown to be more effective than the market leading agent, mupirocin, at decolonising MRSA. This combined with previous work showing that MRSA bacteria aren't resistant to cannabidiol, makes BTX 1801 an ideal candidate to prevent SSIs.
Due to these findings, the company's phase 2a study will evaluate safety, tolerability and efficacy of two BTX 1801 formulations to decolonise Staph and MRSA from the nose of 60 healthy adults.
Studies show that one in three people carry Staph or MRSA in their nose on average. Therefore, the phase 2a study population is ideal to determine the efficacy of BTX 1801 for Food and Drug Administration (FDA) registration.
Final preparations for this study are underway and Botanix expects to enrol its first participants early next quarter.
Botanix Pharmaceutical's shares remain flat and are trading for 7 cents each at 12:51 pm AEDT.