Ann: BTX 1503 End of Phase 2 Milestone with FDA, page-3

SX/Media Release
17 July 2020
BTX 1503 End of Phase 2 Milestone with FDA
• Botanix achieves an important drug development milestone through completion of a successful
End of Phase 2 meeting for BTX 1503 with the FDA
• Botanix has now confirmed a drug development plan to support registration of BTX 1503 for
the treatment of moderate and severe acne
• Planning is now underway for Phase 3 clinical studies with the final outcomes informed by the
completion of the BTX 1702 (rosacea) Phase 2 study and lifting of COVID-19 restrictions
Philadelphia PA and Sydney Australia, 17 July 2020: Clinical stage synthetic cannabinoid company
Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or “the Company”) is pleased to report it has
completed a major milestone in the development of BTX 1503 for the treatment of moderate and
severe acne, with the completion of an End of Phase 2 meeting (“EOP2 Meeting”) with the FDA.
The EOP2 Meeting was held by teleconference, given current COVID-19 travel and social distancing
restrictions, and provided an opportunity for Botanix to seek confirmation from the FDA on the drug
development plan for BTX 1503 to support registration.
A critical component of the development plan was the design of the Phase 3 clinical studies. 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. The FDA also provided feedback on the
development program and agreement was reached on the required co-primary efficacy endpoints for
the Phase 3 studies, which include:
1. Absolute change from baseline in inflammatory and absolute change from baseline in noninflammatory lesion at Week 12; and
2. Proportion of patients with an Investigators Global Assessment (IGA) of “clear” or “almost
clear” and at least a 2-grade improvement in IGA from baseline at Week 12.
Botanix President and Executive Chairman, Vince Ippolito, said: “This is a 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 timetable for the progression of the BTX 1503 Phase 3 study is currently under review, pending
the completion of the Company’s BTX 1702 (rosacea) Phase 2 clinical study and lifting of COVID-19
restrictions. The BTX 1702 program is poised to commence recruitment once travel and clinical study
conduct restrictions are eased across Australia and New Zealand. The BTX 1702 study will examine
two different doses of synthetic cannabidiol and given the overlap in characteristics between acne
and rosacea, is also likely to provide supporting information for BTX 1503 acne program.
Given the current COVID-19 imposed limitations on conducting multi-site global clinical studies,
Botanix does not expect any large Phase 3 dermatology studies to be able to commence before the
end of CY2020. The Company will continue to update investors as clinical development timelines for
BTX 1702 and BTX 1503 become clearer.
Finally, Botanix is preparing to commence its BTX 1801 Phase 2 antimicrobial study in the coming
weeks, which is planned to complete recruitment by the beginning of 4Q CY 2020, with data available
shortly thereafter.
Release authorised by:
Vince Ippolito
President and Executive Chairman