Botanix Pharmaceuticals has completed a pre-investigational new drug meeting with the US Food and Drug Administration’s (FDA) Office of Infectious Diseases.
The meeting assessed the potential of initiating clinical development of the company’s BTX 1801 antimicrobial drug for preventing surgical site infections in the US.
Botanix’s BTX 1801 product is a synthetic cannabidiol antimicrobial gel that is aimed at reducing post-surgical infections. Currently, 80% of these infections are caused by a nasal build-up of the staphylococcus aureus and methicillin-resistant staphylococcus aureus bacteria.
Botanix 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.”
The healthcare stock also presented the FDA with the study design for the phase 2a BTX 1801 study that’s currently underway in Australia.