Botanix Pharmaceuticals plans new study into antimicrobial platform and BTX 1801

Synthetic cannabinoid company Botanix Pharmaceuticals (ASX: BOT) has unveiled the next phase of development for its cannabinoid antimicrobial platform and lead program BTX 1801.

Earlier today, Botanix declared it had achieved “significant progress” and is now commencing its first clinical research – a phase 2a study into BTX 1801, targeting the prevention of surgical site infections (SSIs).

The new study will be a double-blind and vehicle-controlled, and aims to evaluate safety, tolerability and efficacy of two BTX 1801 formulations in decolonising staphylococcus (staph) and methicillin-resistant staph aureus (MRSA) from the nose of healthy adults.

In total, the study will involve 60 volunteers being treated for five days.

Prior to kicking off new research, Botanix has presented new data claiming its findings “demonstrated that synthetic cannabidiol rapidly kills MRSA bacteria within 10 minutes of exposure, by a novel mechanism of action, and without allowing resistance to develop”.

“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,” said Vince Ippolito, executive chairman and president of Botanix.

“The development of BTX 1801 for the prevention of SSIs diversifies our clinical pipeline and opens up a separate business line for Botanix outside our mature dermatology programs,” he added.

Delving into BTX 1801

Designed to target bacterial skin infections, BTX 1801 has been formulated with CBD using Botanix’s proprietary skin delivery technology called Permetrex.

In previous studies, Botanix demonstrated how BTX 1801 functions as a broad-spectrum gram-positive antibiotic that is effective against a range of human and animal bacteria.

According to Botanix, BTX 1801 has similar potency to antibiotics such as vancomycin and daptomycin and is effective against superbugs such as staph and MRSA.

The novelty behind the product is its application of CBD, an additive that kills bacteria within three hours and disrupts the biofilm used by bacteria to protect themselves against antibiotics.

Scientific research and patient outcomes have shown that resistant bacteria such as staph have quickly become a major healthcare concern, especially in countries with high use of antibiotics.

Staph and MRSA are the leading cause of SSIs with approximately 80% of SSIs currently being attributed to patient infecting themselves from their nose, where the bacteria can colonise. This risk area is gradually being addressed by healthcare authorities via the greater use of nasal decolonisation before surgery.

However, antibiotics used for nasal decolonisation such as Bactroban are encountering growing resistance, with some hospitals recording resistance rates as high as 95%.

Moreover, nasal colonisation can lead to greater negative externalities given that patients colonised with staph during admission face a 15-times higher risk of developing pneumonia compared to non-colonised patients.

As a result of its studies and internal development, Botanix says its BTX 1801 product is “more effective than the market-leading decolonisation agent, mupirocin”, against antibiotic-resistant strains of MRSA.

“Given one in three people in the community carry staph and/or MRSA in their nose on average, this study population is ideal to establish proof of efficacy of BTX 1801, before moving into a pivotal clinical study involving patients undergoing surgery, for FDA registration,” the company said.

Final preparations for Botanix’ phase 2a study are now underway with Botanix confirming it expects to enrol its first participants in Q2 2020.