QUÉBEC, Canada, July 21, 2026
Devonian Health Group has received Health Canada authorization to initiate a Phase II/III clinical trial evaluating Thykamine™ (PUR 0110) cream for the treatment of mild-to-moderate pediatric atopic dermatitis in patients aged 3 months to 17 years. The regulatory authorization marks a significant milestone for the clinical-stage biopharmaceutical company, enabling one of the most comprehensive pediatric development programs undertaken for a botanical prescription therapy targeting chronic inflammatory skin disease. Designed as a seamless adaptive Phase II/III study, the trial will assess both the efficacy and safety of two concentrations of Thykamine™ while supporting Devonian’s strategy to develop a novel non-steroidal treatment for children living with atopic dermatitis. The authorization also allows enrollment across the full intended pediatric population, including infants as young as three months of age, reflecting the company’s commitment to addressing a significant unmet medical need.
Health Canada Clears Comprehensive Pediatric Clinical Program
The Health Canada-authorized study will evaluate Thykamine™ cream in approximately 306 pediatric patients with mild-to-moderate atopic dermatitis using a randomized, double-blind, placebo-controlled, multicenter Phase II/III design. Participants will receive either 0.05% Thykamine™, 0.1% Thykamine™, or placebo cream administered twice daily over a 12-week treatment period. The study’s primary endpoint will assess the proportion of patients achieving treatment success based on the validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) at Week 12, while secondary endpoints will evaluate overall safety, tolerability, treatment durability, symptom improvement, reduction in affected body surface area, patient-reported outcomes, and quality of life. The adaptive trial design incorporates an interim analysis after Phase II, enabling a seamless transition into the confirmatory Phase III portion if predefined criteria are achieved.
Safety Oversight and Experienced Clinical Leadership
The pediatric development program will be led by internationally recognized dermatologist Dr. Charles Lynde, who will serve as Principal Investigator and oversee a network of specialized dermatology research centers across Canada. Patient safety will remain a central component of the study through continuous oversight by an independent Data Safety Monitoring Committee (DSMC), which will review adverse events, evaluate safety outcomes, and determine progression between age cohorts. Enrollment will begin with children aged 2 to 17 years, followed by infants aged 3 months to 2 years only after DSMC review and approval. This structured approach is intended to ensure the highest standards of patient safety while maintaining clinical development efficiency. Devonian believes the rigorous trial design, combined with experienced clinical leadership, positions the study to generate robust evidence supporting future regulatory development.
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Building on Positive Adult Data for Pediatric Innovation
The pediatric trial builds upon previously completed Phase II clinical results in adults, where Thykamine™ demonstrated statistically significant efficacy together with an excellent safety profile in patients with mild-to-moderate atopic dermatitis. Developed from Devonian’s proprietary SUPREX™ platform, Thykamine™ possesses anti-inflammatory, antioxidant, and immunomodulatory properties that have shown promise across multiple inflammatory and autoimmune conditions. Atopic dermatitis affects millions of children worldwide, with the majority developing symptoms during early childhood, creating a substantial need for safe long-term treatment options beyond conventional steroid therapies. By advancing this Health Canada-authorized pediatric clinical program, Devonian aims to establish Thykamine™ as an innovative non-steroidal botanical prescription therapy capable of improving long-term disease management while expanding treatment options for pediatric patients living with chronic inflammatory skin disease.
Source: Devonian Health Group Press release
