- Synthetic cannabinoid company Botanix Pharmaceuticals (BOT) has completed an End of Phase 2 (EOP2) meeting with the Food and Drug Administration (FDA)
- This meeting allowed Botanix to seek confirmation from the FDA on the drug development plan for BTX 1503 and gain registration support
- BTX 1503 is a transdermal gel formulation that is used for the treatment of serious acne in adults and teenagers
- The FDA highlighted the excellent safety profile of BTX 1503 and provided feedback on the development program and outcomes for the phase three trial
- The phase three trial is currently under review and will progress when Botanix completes the BTX 1702 phase two study on patients with rosacea
- Unfortunately, due to COVID-19, the company believes the BTX 1503 trial won’t begin before the end of 2020
- Botanix’s share price has dropped a slight 1.85 per cent and shares are currently trading for 5.3 cents each
Synthetic cannabinoid company Botanix Pharmaceuticals (BOT) has completed an End of Phase 2 (EOP2) meeting with the Food and Drug Administration (FDA).
Given travel restrictions and social distancing arising from COVID-19, the EOP2 meeting was held by teleconference.
This meeting allowed Botanix to seek confirmation from the FDA on the drug development plan for BTX 1503 and gain registration support.
BTX 1503 is a transdermal gel formulation that is used for the treatment of serious acne in adults and teenagers. Its aim is to reduce the occurrence and severity of acne.
The FDA highlighted the excellent safety profile of BTX 1503 and provided feedback on the development program and efficacy outcomes for the phase three trial.
These outcomes include absolute change from baseline in both inflammatory and non-inflammatory lesions at week 12, and patients having a clear or almost clear reading on the Investigators Global Assessment (IGA) scale at week 12.
The phase three trial is currently under review and will progress when Botanix completes the BTX 1702 phase two study and when COVID-19 restrictions are lifted.
The BTX 1702 phase two trial, which carried out on patients with rosacea (skin inflammation in the face) will begin recruitment once travel restrictions between Australia and New Zealand are eased.
This trial will test two different doses and the findings are likely to provide supporting information for the BTX 1503 program.
Unfortunately, Botanix doesn’t expect any phase three studies will begin this year but it will update the market as the timelines become clearer.
“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,” President and Executive Chairman Vince Ippolito said.
“Our dose ranging BTX 1702 study will inform our final design for phase three BTX 1503 studies and we look forward to commencing that program as soon as COVID-19 restrictions are lifted,” he added.
Botanix’s share price has dropped a slight 1.85 per cent and shares are trading for 5.3 cents each at 12:35 pm AEST.