- Devonian Health Group has received Health Canada authorization to begin a Phase II/III trial of Thykamine (PUR 0110) cream for mild-to-moderate atopic dermatitis in children and adolescents aged 3 months to 17 years.
- The 306-patient trial will evaluate two concentrations of Thykamine (0.05% and 0.1%) against placebo over 12 weeks, with the primary endpoint focused on achieving clear or almost clear skin.
- The study will use a seamless adaptive Phase II/III design, with independent safety oversight and an interim analysis to support the transition into the confirmatory Phase III stage.
- The pediatric program builds on positive Phase II results in adults and aims to develop a potential non-steroidal botanical treatment option for children living with atopic dermatitis, including infants as young as 3 months.
Takeaways:
Health Canada’s go‑ahead for Devonian’s seamless Phase II/III pediatric Thykamine program positions the company to enter a crowded but fast‑growing non‑steroidal topical eczema market with a botanical cream differentiated by use down to 3 months of age, and if trial results match adult Phase II data, it could become an attractive steroid‑sparing option that competes alongside established calcineurin, PDE‑4, and JAK inhibitors while raising the profile and valuation of Devonian’s botanical dermatology platform.
Source: CA Newswire
