Botanix Pharmaceuticals (ASX:BOT) has crossed a major milestone by commencing the Phase 1a study for its lead acne treatment product, BTX 1503.
BTX 1503 is a topical treatment for moderate to severe acne, which utilises synthetic cannabidiol as the active ingredient, together with Botanix’s proprietary Permetrex™ drug delivery technology.
The Phase 1a study will be conducted over the coming weeks, with data from the study expected to be available by the end of June 2017.
This is the first study designed to provide the safety, dosing and pharmacokinetic data for BTX 1503 and will support the rapid advancement of BTX 1503 into a pilot acne patient trial.
Acne is the most common skin disorder in the U.S. affecting 40-50 million Americans.
BTX 1503 is targeting the market for prescription acne market products that currently generates more than $4.5 billion in annual sales.
Scientific data suggests that BTX 1503 may inhibit the excessive production of oil in the skin, which is a primary cause of acne, as well as potentially reducing inflammation and bacterial infection.
Currently the only approved product that has an effect on oil production also carries significant side effects, including birth defects, lymphoma and suicide risks.
BTX 1503 is expected to have a far superior side effect profile, based on the published clinical data for cannabidiol in other disease indications.
Botanix’s cash balance as at 31 March 2017 was $1.53 million.