Australian clinical dermatology and antimicrobial company Botanix Pharmaceuticals (ASX:BOT) has released a clinical development update of its antimicrobial platform with the identification of a potential new indication.
The company said the potential new indication targets the prevention of bloodstream infections in haemodialysis patients.
Vince Ippolito, president and executive chairman, said, “We are very excited to announce the clinical development update for our BTX 1801 antimicrobial platform. Our assessment indicates that haemodialysis patients with central venous catheters are at considerable risk of bloodstream infections, with no currently approved treatments.
"BTX 1801’s novel mechanism of action has been shown to rapidly kill Staph aureus and MRSA without generating resistance, and the recent positive Phase 2a study data demonstrated the clinical utility of BTX 1801 as a nasal decolonisation agent. This represents a potential novel approach for removing sources of bacteria to prevent bloodstream infections in haemodialysis patients, representing a valuable market opportunity to significantly lower the health system impact of haemodialysis infections.”
The company said clinical data generated to date indicates synthetic cannabidiol has a bactericidal mechanism of action that kills Staphylococcus aureus (Staph aureus) and drug-resistant Staph aureus (MRSA) without generating antimicrobial resistance.
The company also recently announced positive top-line data from a phase 2a study with the efficacy of BTX 1801 demonstrated by nasal decolonisation of Staph aureus.
"Following an extensive assessment of clinical data generated to date with key opinion leaders and after a thorough review of potential market opportunities, Botanix has identified its target indication for next phase of clinical development for BTX 1801 – nasal decolonisation of Staph aureus in patients undergoing haemodialysis treatment in order to reduce the incidence of life-threatening bloodstream infections," said the company in a statement.
Patients undergoing ongoing dialysis regularly - three to five times per week - are at a high risk of bloodstream infections due to their treatment requiring frequent use of catheters which in the first year are routinely central lines with direct access to the heart.
Botanix said the potential benefit of BTX 1801 in haemodialysis patients to prevent bloodstream infection is supported by previous studies using mupirocin. However, it said despite these successful studies, mupirocin was never approved and is not expected to be a suitable long-term solution for haemodialysis patients given the high level of resistance and the fact it is now generic.
The company said it is finalising plans to progress BTX 1801 into a Phase 2b study to assess its efficacy at killing Staph aureus over a three month treatment period with three times weekly treatment of the nose.