Medical dermatology company Botanix Pharmaceuticals Limited announced the successful results of its randomised, double-blind, vehicle (placebo) controlled Phase 1b atopic dermatitis (AD) patient study, designed to evaluate the safety, tolerability and pharmacology of BTX 1204.
The randomised, double-blind, vehicle-controlled Phase 1b study was conducted at five dermatology sites in Australia and enrolled 37 patients with mild to moderate atopic dermatitis. Eligible patients were randomised to receive either BTX 1204 or the vehicle (placebo – contains no active drug) applied twice daily for four weeks. 25 patients were randomly assigned to the BTX 1204 group and 12 patients were randomly assigned to the vehicle group. While primarily a safety study, the study also assessed for early signs of efficacy through improvements in the signs and symptoms of AD following treatment. 32 patients successfully completed the Phase 1b study.
Top line data indicates BTX 1204 was well-tolerated as there were no significant adverse effects, or reports of skin irritation during the study. The effects of BTX 1204 on the Signs of AD were assessed by comparing the proportion of patients achieving treatment success with BTX 1204 after 4 weeks of treatment, to the proportion of patients achieving treatment success treated with the vehicle. Treatment success was defined as a greater than, or equal to a 4 point improvement in the Signs of AD. After 4 weeks of treatment, 35% of patients receiving BTX 1204 achieved treatment success, compared to only 18% of patients who received the vehicle.
Botanix Executive Director Matt Callahan said “these results show that BTX 1204 was twice as effective as the vehicle in providing a clinical meaningful outcome to patients with AD. We are extremely encouraged by these positive results. 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.”
Even though the study was not statistically powered to show differences in efficacy, significant improvements from baseline in each individual sign of AD including erythema (inflammation), exudation (ooze from the lesion) and lichenification (thickening of the skin in response to itching) were observed after 4 weeks in patients treated with BTX 1204, compared with patients receiving the vehicle. An important outcome of the study was the improvement observed in those Signs of AD, that are associated with the chronic form of the disease, specifically a reduction in exudation and lichenification. These key signs are more severe in chronic AD and are directly related to an increase in itch (pruritis) of the lesions. As there is currently no effective treatment for chronic sufferers of itch (whether AD patients or as a symptom of other skin diseases), BTX 1204 represents a potential new treatment for these patients.
Dr Kurt Gebauer, a key opinion leader in dermatology and Clinical Associate Professor of Dermatology commented, “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.”
Based on these results, Botanix plans to review the corporate opportunities for the further development of BTX 1204, either pursuant to a partnering or licensing arrangement with other dermatology companies, or through conducting a Phase 2 study for BTX 1204.
Mr Callahan added, “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. Inflammation is a consistent theme across the other common skin diseases that Botanix is targeting. These results continue to validate and support the broader potential of the Botanix product portfolio.”
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