Botanix Pharmaceuticals Ltd (ASX:BOT) (OTCMKTS:BXPHF) has completed a phase 2a clinical study for its BTX 1801 antimicrobial for the treatment of gram-positive bacteria.
Antimicrobial resistance has been identified as the next health crisis to test our vulnerabilities, called out by major global health authorities including the World Health Organisation (WHO) and Food and Drug Administration (FDA).
The BTX 1801 phase 2a clinical study was designed to test the ability of two different formulations of BTX 1801 to eradicate or ‘decolonise’ nasal carriage of Staphylococcus aureus (Staph) and methicillin-resistant Staphylococcus aureus (MRSA) from the nasal cavity of healthy participants.
Finalisation of data collection is underway to support database lock, data analysis and generation of top-line data early in quarter one of 2021.
“Worked diligently” to complete study
Botanix president and executive chairman Vince Ippolito said: “There has not been a new class of antibiotic for the treatment of gram-positive bacteria in more than 30 years and serious Staph and MRSA infections have become very difficult to treat.
“The company has worked diligently to complete the BTX 1801 Phase 2a study despite the significant disruption caused by the COVID-19 pandemic by conducting the study in Western Australia.
“We are very thankful to our study participants, our Perth site staff and study collaborators and we look forward to updating the market once top-line data are available early in the New Year.”
To seek advice from FDA
In April this year, Botanix announced that the US FDA’s office of antimicrobial products had granted BTX 1801 Qualified Infectious Disease Product (QIDP) status for the prevention of post-surgical infections.
Last month, Botanix successfully completed a Pre-Investigational New Drug (Pre-IND) meeting with the FDA for its BTX 1801 synthetic CBD antimicrobial product.
The Pre-IND meeting provided Botanix with an opportunity to seek advice and clarification from the FDA on the development plan and data package required to initiate clinical studies for BTX 1801 in the US.
It also enabled Botanix to gain feedback from the FDA on the drug development plan required for BTX 1801 to support a Fast-Track designation and New Drug Application in light of its existing Qualified Infectious Disease Product designation.