ASX-listed dermatology and antimicrobial company Botanix Pharmaceuticals has received ethics approval for a Phase 1b clinical study of its BTX 1702 formulation for the treatment of chronic inflammatory skin disease, papulopustular rosacea.
Two different active formulations of BTX 1702 will be studied, both of which leverage the company’s proprietary drug delivery system Permetrex, together with synthetic cannabidiol.
The expanded phase 1b study will now be a randomised, double-blind, vehicle-controlled study in patients with moderate to severe papulopustular rosacea.
It is planned to enrol approximately 120 patients across 11 dermatology clinic sites in Australia and New Zealand, with the study due to start in early Q2 2021.
Papulopustular rosacea is a highly visible and distressing chronic inflammatory skin disease characterised by intensely inflamed skin and acne-like breakouts across the face.
Botanix president and executive chairman Vince Ippolito said: “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 initiating this clinical study with leading investigators in Australia and New Zealand.”