Dermatology company Botanix Pharmaceuticals (ASX: BOT) has published successful results from its phase 1b patient study looking into the safety profile of its cannabidiol-based BTX 1204 transdermal gel that aims to treat atopic dermatitis.
Atopic dermatitis (a severe form of eczema that appears as itchy inflammation of the skin) currently affects between 15-30 million people in the United States and around “10-15% of Australia’s population including 39% of all children,” according to the University of Melbourne.
Although Botanix’s published results do not conclusively prove efficacy as such, the study has given the company hope that it can be the first to develop an effective treatment for chronic atopic dermatitis sufferers.
There is currently no effective treatment for atopic dermatitis and Botanix says its BTX 1204 represents a viable avenue with strong potential, having kicked off the study in April this year.
BTX 1204 uses cannabidiol as its prime ingredient which research suggests can potentially be effective in treating the condition.
“In addition to confirming the significant potential of BTX 1204 for atopic dermatitis, these results again provide further evidence of the anti-inflammatory effects of synthetic cannabidiol,” said Matt Callahan, executive director of Botanix Pharmaceuticals.
The randomised, double-blind, vehicle-controlled study was conducted at five dermatology sites in Australia with 37 patients enrolled with mild to moderate atopic dermatitis.
Eligible patients were randomised to receive either BTX 1204 or the placebo (vehicle), which were both applied twice daily for four weeks.
Out of the group, 32 patients successfully completed the study.
Top line data indicates BTX 1204 was “well-tolerated” with no significant adverse effects or reports of skin irritation. After four weeks of treatment, 35% of patients receiving BTX 1204 achieved treatment success, compared to only 18% of patients who received the placebo.
“These results show that BTX 1204 was twice as effective as the vehicle in providing a clinically meaningful outcome to patients with atopic dermatitis. BTX 1204’s efficacy profile is in line with existing topical products whose treatment success rates are typically between 25-35%,” said Mr Callahan.
“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,” he added.
One of the primary causal factors considered to be driving the strong increase in dermatitis conditions such as eczema and psoriasis in developed countries, more so than less developed countries, is the strong disposition towards using chemicals, soaps and artificial cleaning agents on a daily basis.
According to the BHC Medical Centre based in Lakemba, NSW, “overly hygienic practices in modern societies are contributing to the physical abuse of the skin barrier – the first line of defence against microorganisms.”
An important outcome of the study was the strongest rate of improvement was observed amongst the most severely affected patients, specifically, in the reduction of exudation (oozing lesions) and lichenification (thickening of the skin).
The Eczema Association of Australasia estimates that the average eczema sufferer will typically spend around A$425 per year on various treatment options with costs reaching as high as A$2,000 per individual, depending on the severity of the symptoms.
“Physicians and patients require new treatment options for mild to moderate atopic dermatitis with improved side effect profiles particularly for the many children suffering from this condition. The safety of BTX 1204 and the known safe therapeutic use of synthetic cannabidiol in children for other diseases points to BTX 1204 potentially being a significant new therapy for atopic dermatitis,” said Dr Kurt Gebauer, clinical associate professor at Fremantle Dermatology.
With initial phase 1b results now in, Botanix says it intends to conduct a phase 2 study and hasn’t ruled out a partnering or licensing arrangement with other dermatology companies in the near future.
Shares in Botanix were down more than 11% to A$0.16 by midday.