Clinical stage synthetic cannabinoid company Botanix Pharmaceuticals (ASX:BOT) says it has conducted an 'end of phase two' meeting with the US FDA in relation to the development of BTX 1503 for the treatment of moderate and severe acne.
The company said the meeting was held by teleconference in response to current COVID-19 travel and social distancing restrictions. It said the meeting was an opportunity to seek confirmation from the FDA on the drug
development plan for BTX 1503 to support registration.
Botanix said the design of phase three studies is a critical component of that development plan.
"The FDA highlighted the excellent safety profile of synthetic BTX 1503, by allowing several waivers for studies
that are normally required for dermatology drug registration," said the company in a statement, adding there was agreement on the co-primary efficacy endpoints for the phase three studies.
These endpoints include the absolute change from baseline in inflammatory and absolute change from baseline in noninflammatory lesion at week 12 and the proportion of patients with an Investigators Global Assessment (IGA) of 'clear' or 'almost clear' and at least a two-grade improvement in IGA from baseline at Week 12.
According to Botanix president and executive chairman, Vince Ippolito, “This is an important milestone for our drug development program. We are very pleased with the FDA feedback and now have clarification on the development program to support a New Drug Application for BTX 1503.
Our dose ranging BTX 1702 (rosacea)study will inform our final design for the Phase 3 BTX 1503 studies and we look forward to commencing that program as COVID-19 restrictions are lifted.”
The company said the timetable for the progression of the BTX 1503 phase three study is currently under review, pending completion of the BTX 1702 (rosacea) phase two clinical study and the lifting of COVID-19 restrictions.
The BTX 1702 study will examine two different doses of synthetic cannabidiol. However, given the current COVID-19 imposed limitations on conducting multi-site global clinical studies, Botanix said it does not expect any large phase three dermatology studies to commence before the end of 2020.