Botanix Pharma moves ahead on trialing its unique cannabinoid formulation BTX 1702 for papulopustular rosacea.
BTX 1702 utilizes Botanix's proprietary drug delivery system, Permetrex, alongside synthetic cannabidiol in a new formulation.
The Phase 1b study will be a randomised, double-blind & vehicle-controlled and will involve patients that have moderate to severe papulopustular rosacea. Botanix has planned to enrol roughly 120 patients across Australia.
Rosacea is an inflammatory skin condition which results in frequent and persistent blushing, flushing or redness across ones face, and can develop into much more severe forms of rosacea such as papulopustular rosacea.
Papulopustular rosacea affects over 16 million Americans and is an extreme form of rosacea that is much more noticeable due to the high level of inflammation of the face which can cause acne-like breakouts and red, inflamed skin.
Rosacea predominantly affects women, and the vast majority of rosacea sufferers are over the age of 30.
Botanix's Phase 1b study is designed to assess the safety profile and tolerability of BTX 1702 over a six week trial period. The primary endpoint is to see "absolute change and percentage change in inflammatory lesion counts (papules and pustules)" as well as the reduction of redness while ensuring the safety of the trial patients.
The study will involve two different active formulations of BTX 1702, both of which will utilize the Permetrex delivery technology with synthetic CBD sourced from Botanix's partner Purisys. The study will include two separate vehicle arms, with each enrolling approximately 30 patients.
Disclaimer: Past performance is not an indicator of future performance.
Dr. Kurt Gebauer, the Clinical Associate Professor of Dermatology commented: "Moderate to severe papulopustular rosacea patients are greatly in need of new therapies to treat the signs and symptoms of the disease which has such a tremendous emotional impact."
BTX 1702 offers a novel potential option for papulopustular rosacea with a unique mechanism of action which could target several aspects in the pathogenesis of the disease, and we are very excited to be participating in this clinical study. Dr. Kurt Gebauer, the Clinical Associate Professor of Dermatology
Botanix has launched the final preparations for the study, with expectations to enrol first patients in early 2020. To visit their company HQ, click here.
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