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- Botanix Pharmaceuticals (BOT) has received ethics approval for a clinical study into the use of BTX 1702 to treat papulopustular rosacea
- BTX 1702 leverages the company’s proprietary drug delivery system Permetrex with synthetic cannabidiol in a new formulation
- The company plans to enrol around 120 patients with moderate to severe papulopustular rosacea in the study, across 11 dermatology clinic sites in Australia and New Zealand
- Two different concentrations of the treatment will be tested over 57 days to test the treatment’s safety, tolerability and effectiveness
- Final preparations for the study are now underway, with first patients expected to enrol in Q2 2021
- Botanix is trading flat at 10 cents per share
Botanix Pharmaceuticals (BOT) has received ethics approval for a clinical study into the use of BTX 1702 to treat papulopustular rosacea.
BTX 1702 leverages the company’s proprietary drug delivery system Permetrex with synthetic cannabidiol in a new formulation.
The Phase 1B clinical study will be a randomised, double blind, vehicle-controlled study in patients with moderate to severe papulopustular rosacea, a chronic inflammatory skin disease characterised by intensely inflamed skin and acne-like breakouts across the face.
Rosacea affects more than 16 million Americans and up to 415 million people worldwide.
The company plans to enrol around 120 patients in the study, across 11 dermatology clinic sites in Australia and New Zealand.
The study will investigate the safety and tolerability of BTX 1702 in adults over an eight-week treatment period. Additionally, the company will be looking to assess the change and percentage of inflammatory papules and pustules in patients over 57 days.
Two different concentrations of the treatment will be tested, along with a separate vehicle arm, with each active and vehicle arm enrolling approximately 40 patients for a study total of approximately 120.
The new program follows a recent antimicrobial study that showed synthetic cannabidiol exerts powerful anti-inflammatory and antimicrobial actions in skin, which are two activities critical to successfully treating rosacea.
These studies suggest that synthetic cannabidiol treatment incorporating the Permetrex skin delivery technology could represent a safe and effective new option for rosacea patients.
“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,” said President and Executive Chairman, Vince Ippolito.
“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 says it is well funded to progress both its dermatology and antimicrobial platforms, after receiving a $6.85 million research and development tax incentive, in addition to the $19.2 million in cash held by the company at the end of 2020.
Final preparations for the study are now underway, with first patients expected to enrol in Q2 2021.
Botanix is trading flat at 10 cents per share at 10:10 am AEDT.
