Botanix Pharmaceuticals Ltd (ASX:BOT) has successfully completed a vehicle (placebo) controlled phase Ib study of BTX 1204 in patients with mild to moderate atopic dermatitis.
BTX 1204 is a novel topical formulation of synthetic cannabidiol that utilises Botanix’ proprietary drug delivery system Permetrex.
Twice as effective as the placebo
Top line data indicates BTX 1204 was well-tolerated as there were no significant adverse effects, or reports of skin irritation during the study.
Importantly, BTX 1204 was effective at reducing the key signs and symptoms of atopic dermatitis after only four weeks of treatment
After four weeks of treatment, 35% of patients receiving BTX 1204 achieved treatment success, compared to only 18% of patients who received the vehicle.
Potential new treatment option for atopic dermatitis
About 18 to 25 million people in the United States suffer from atopic dermatitis, including between 8% to 18% of infants and children.
Atopic dermatitis has been considerably under-diagnosed due to the lack of approved effective systemic agents, and limitations of current topical agents.
Botanix executive director Matt Callahan said: “BTX 1204’s efficacy profile is in line with existing topical products whose treatment success rates are typically between 25-35%.
This combined with the excellent safety profile demonstrated to date underlines the potential for BTX 1204 to be a very safe and exciting new treatment for the millions of patients who suffer from this disease.”