Devonian Health Group Inc. (TSXV: GSD) announced on July 21st that it has received a Clinical Trial Application authorization from Health Canada to initiate a Phase II/III clinical study of its PUR 0110 (Thykamine™) cream for the treatment of mild-to-moderate atopic dermatitis in pediatric patients.
This authorization, which permits the study to cover the full pediatric population from infants as young as 3 months to adolescents up to 17 years old, represents a key regulatory milestone for Devonian. The trial will be led by Dr. Charles Lynde, a Clinical Associate Professor of Dermatology at the University of Toronto and a globally recognized dermatology expert, and will be conducted across multiple leading pediatric dermatology centers.
The trial employs a seamless adaptive Phase II/III design, planning to enroll approximately 306 pediatric patients: 102 in Phase II, with an additional 204 in Phase III. Patients will be evenly assigned to receive either Thykamine cream at 0.05% or 0.1% concentrations, or a placebo. The primary efficacy endpoint is the proportion of patients achieving a vIGA-AD score of "clear" or "almost clear" with at least a two-grade improvement from baseline after 12 weeks of treatment. The study will include an independent Data Safety Monitoring Board and will use a sequential enrollment strategy for two age groups (69 patients aged 2-17 years and 33 patients aged 3 months to 2 years) with predefined stopping rules to ensure patient safety.
André P. Boulet, CEO of Devonian, stated that this authorization reflects the strength of the company's scientific and regulatory strategy, as well as the urgent need for safe and effective treatments for pediatric atopic dermatitis. This pediatric program is based on positive results from a prior Phase II trial in adults, which were published in the peer-reviewed Journal of Drugs in Dermatology, showing Thykamine cream had statistically significant efficacy and a favorable safety profile in adults with mild-to-moderate atopic dermatitis. Atopic dermatitis is one of the most common chronic inflammatory skin diseases in children globally, with approximately 60% of patients showing symptoms within their first year and 85% by age five.