Botanix Pharmaceuticals Ltd (ASX:BOT) (OTCMKTS:BXPHF) has received ethics approval for its planned BTX 1702 Phase 1b clinical study for the treatment of papulopustular rosacea and is expanding the study design to start early next quarter.
BTX 1702 leverages the company’s proprietary drug delivery system PermetrexTM with synthetic cannabidiol in a new formulation.
The phase 1b study will now be a randomised, double-blind, vehicle-controlled study in patients suffering from moderate to severe papulopustular rosacea.
It is planned to enrol approximately 120 patients across 11 dermatology clinic sites in Australia and New Zealand.
Papulopustular rosacea is a highly visible and distressing chronic inflammatory skin disease characterised by intensely inflamed skin and acne-like breakouts across the face.
“Excited to initiate clinical study”
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.”
Phase2a antimicrobial study
The new BTX 1702 program is being initiated following the recent successful Phase 2a BTX 1801 antimicrobial study and leverages the mechanistic data previously generated by Botanix, which showed synthetic cannabidiol exerts powerful anti-inflammatory and antimicrobial actions in the skin – two key activities that are critical to successfully treating rosacea.
These studies suggest that synthetic cannabidiol delivered using the PermetrexTM skin delivery technology could represent a safe and effective new option for rosacea patients.
Phase 1b clinical study design
The Phase 1b study will investigate the safety and tolerability of BTX 1702 in adults over an 8-week treatment period.
This study’s primary objective is to assess safety and tolerability, along with exploratory endpoints including absolute change and percentage change in inflammatory lesion counts.
Patients aged 18 to 65 who have moderate to severe papulopustular rosacea and meet other eligibility and inclusion criteria are eligible to be enrolled.
The study design has been updated and expanded in recent months to enable increased data capture and to provide additional insights to support Botanix’s broader dermatology platform – this will include additional information supporting the unique delivery capabilities of the company’s proprietary drug delivery system, PermetrexTM.
Some of the design changes include a centralised review of each investigator’s ratings and universal use of advanced Canfield imaging technology to support clinical assessments and improve patient tracking.
Quality of study data
The company believes that these process and technology improvements to the study design will greatly enhance the quality of the study data and reduce the potential for site-to-site assessment variances.
Two different concentrations of BTX 1702 will be tested in the study along with a separate vehicle (control) arm, with each active and vehicle arm enrolling approximately 40 patients for a study total of approximately 120.
Final preparations for the study are underway and the company expects to enrol first patients early next quarter.
Financial outlook
The company is well-funded to progress its dermatology and antimicrobial platforms, with the recent receipt of the $6.85 million R&D Tax Incentive in addition to the $19.2 million in cash held by the company on December 31, 2020.
Moreover, Botanix continues to assess complementary opportunities and partnerships for dermatology and antimicrobial products that can be rapidly brought to market which leverage the company’s broad management experience capability and experience.