Clinical stage cannabinoid company Botanix Pharmaceuticals (ASX:BOT) says it has successfully completed a Pre-Investigational New Drug (Pre-IND) meeting with the US FDA's Office of Infectious Diseases for its lead antimicrobial program, BTX 1801.
The company said the Pre-IND meeting provided it with an opportunity to seek advice and clarification from the US regulator on the development plan and data package required to initiate clinical studies for BTX 1801 in that country.
It said it also enabled the company 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 (NDA).
The company said that, in advance of the meeting, it had submitted a comprehensive briefing package outlining the successful results from its pre-clinical studies and future manufacturing and clinical development plans.
Botanix said it also presented the FDA with an update and the study design of the Phase 2a BTX 1801 clinical study currently underway in Western Australia.
According to the company, the FDA advised that the proposed drug development plan and data package presented were sufficient to initiate clinical development in the US and ultimately support an NDA submission.
"The FDA encouraged Botanix to request a Fast Track designation for BTX 1801 following submission of an IND application for BTX 1801," said the company.
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 company also confirmed that the BTX 1801 Phase 2a antimicrobial study is now fully enrolled and remains on track for completion in late 2020. The Phase 2a study aims to test the ability of nasally applied BTX 1801 to eradicate Staphylococcus aureus (Staph) and methicillin-resistant Staphylococcus aureus (MRSA) from the nose of individuals known to carry these bacteria in their nasal cavity.