Pharmaceutical company Botanix Pharmaceuticals Limited (ASX:BOT) has been given ethics approval for a new study that will test synthetic cannabidiol as a treatment for a common form of Rosacea.
Papulopustular rosacea is a chronic inflammatory skin disease that leaves sufferers with intensely inflamed skin and acne-like breakouts across the face. It is a type of rosacea that affects over 415 million people worldwide. Papulopustular rosacea is most common in women, and 85% of sufferers are over 30.
According to Botanix President and Executive Chairman Vince Ippolito, it is essential to test new treatments like BTX 1702, as papulopustular rosacea sufferers are “greatly in need” of new treatments for the painful and highly visible conditions.
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.
Botanix will be conducting a Phase 1B clinical study that will treat people with papulopustular rosacea with two active formulations of the company’s drug BTX 1702. BTX 1702 is applied to the skin through Botanix’s drug delivery system, Permetrex. Its formulation includes synthetic cannabidiol.
Botanix’s clinical trial will include approximately 120 people with moderate and severe papulopustular rosacea. The trial will be carried out at 11 dermatology clinic sites across Australia and New Zealand. It will last a total of eight weeks.
Throughout the study, researchers will be measuring changes in participants’ inflammatory lesions (including papules and pustules) and changes in redness (“erythema”), as well as how well participants tolerate BTX 1702.
Synthetic cannabidiol is quickly gaining momentum worldwide as a treatment for inflammatory skin conditions like rosacea, as it has anti-inflammatory and antimicrobial properties. Botanix proved this themselves with a recent Phase 2a study. According to the company, results from their previous Phase 2a study suggest that synthetic cannabidiol might be a “safe and effective new option for rosacea patients”.
The new trial will be partially funded by a $6.85 million R&D tax incentive Botanix received from the government.
Botanix expects to start their new synthetic cannabidiol and papulopustular rosacea trial in the second quarter of the 2021 calendar year. The company has just finished another clinical trial, which tested CBD on gram-negative bacteria.