Dermatology and antimicrobial company, Botanix Pharmaceuticals (ASX:BOT), has announced it has received ethics approval for the BTX 1702 Phase 1b clinical study for the treatment of papulopustular rosacea and an expansion of the study design.
Botanix said BTX 1702 uses the company's drug delivery system Permetrex with synthetic cannabidiol in a new formulation.
The Phase 1b study will 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.
Rosacea is a chronic inflammatory skin disease that often begins with a tendency to blush or flush more easily than other people. It can progress into many subtypes, including papulopustular rosacea, which is a highly visible and distressing chronic inflammatory skin disease characterised by intensely inflamed skin and acne-like breakouts across the face.
Women are more likely to have rosacea than men and more than 85 per cent of patients are over the age of 30.
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.”
The company said the new BTX 1702 program is being initiated following the recent successful Phase 2a BTX 1801 antimicrobial study. It also leverages the previously generated mechanistic data that showed synthetic cannabidiol exerts powerful anti-inflammatory and antimicrobial actions in skin.
The Phase 1b study will investigate the safety and tolerability of BTX 1702 in adults over an 8-week treatment period. The primary endpoint is a safety and tolerability assessment, along with exploratory endpoints including absolute change and percentage change in inflammatory lesion counts (papules and pustules) from baseline to day 57; change from baseline in the Investigator’s Global Assessment (IGA-PP) scale at days 29 and 57; and, reduction of erythema (redness) severity assessments by each patient and investigator.