Botanix Pharma (ASX:BOT) may soon be able to initiate clinical development of its cannabinoid-derived antimicrobial formula BTX 1801 in the United States, following a positive discussion with the FDA.
Botanix Pharmaceuticals (ASX:BOT) just completed a successful Pre-Investigational New Drug meeting regarding the company's antimicrobial drug BTX 1801, with the US Food and Drug Administration's (FDA) Office of Infectious Diseases.
The formula is designed to specifically aid surgical site infections (SSIs), as caused by staph infections and the superbug Methicillin-resistant Staphylococcus aureus, often referred to as MRSA.
During the meeting, Botanix was able to gain insights into the development plan needed for BTX 1801 to begin clinical studies, as well as gaining a 'Fast Track designation' and 'New Drug Application (NDA).
On a positive note, the FDA advised that Botanix's drug development plan for the Phase 2a study design of BTX 1801 would be sufficient to initiate clinical development as well as supporting a New Drug Application, in addition to the FDA encouraging Botanix to request a fast track designation for the formula.
Phase 2a studies into BTX 1801 will be double-blind and vehicle-controlled, testing for BTX 1801's ability to eliminate Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA) as carried in the nasal cavity.
Currently, Bactroban is the most widely used antibiotic that is used nasally to prevent surgical site infections, but as we've covered previously, this has led to the issue of bacterial resistance – hence the need for BTX 1801.
The upcoming studies are fully enrolled and are scheduled to be completed in 4Q CY 2020, with the results available shortly afterward.
On the announcement, Botanix's President and Executive Chairman Vince Ippolito said "We are very pleased with the excellent outcomes from the Pre-IND meeting. Botanix is now well placed to initiate clinical development of BTX 1801 in the US under an accelerated development path with the FDA."
To learn more about Botanix Pharma, visit their company HQ here.
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