Devonian Health Group has received authorisation from Health Canada for its clinical trial application (CTA) to begin a Phase II/III study of Thykamine (PUR 0110) cream to treat mild-to-moderate atopic dermatitis in paediatric patients.
The study will evaluate two concentrations of Thykamine cream in children aged from three months to 17 years.
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Its main aim is to determine the cream’s efficacy after 12 weeks of twice-daily treatment compared to placebo. Secondary objectives focus on overall safety and tolerability.
The study will use a seamless adaptive Phase II/III design, with an interim analysis after Phase II to allow possible transition to Phase III.
In total, around 306 patients are expected to be enrolled, 102 in Phase II, followed by an additional 204 in Phase III.
Participants will be randomly assigned to receive either Thykamine cream at 0.05%, 0.1% concentrations, or a placebo.
The trial’s primary efficacy endpoint is the proportion of patients achieving treatment success at week 12, specifically those with a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) and at least a two-grade improvement from baseline.
Patient safety throughout the study will be overseen by an independent data safety monitoring committee (DSMC), which will review adverse events and may recommend trial termination if concerns arise.
Enrolment will begin with 69 patients between ages two and 17 years, followed by a second cohort of 33 patients aged three months to two years, subject to DSMC approval after safety assessment.
Lynde Institute dermatology medical director and University of Toronto associate clinical professor Dr Charles Lynde will serve as the study’s principal investigator.
The trial builds on a previous adult Phase II study, in which Thykamine demonstrated statistically significant efficacy and a favourable safety profile.
Devonian Health Group president and CEO Dr André Boulet said: “Receiving Health Canada’s authorisation to initiate this paediatric clinical trial represents a major milestone for Devonian and validates the strength of our scientific and regulatory strategy. We appreciate Health Canada’s thorough scientific review and constructive interactions throughout the clinical trial application process.
“The authorisation to study Thykamine across the full paediatric age spectrum, including infants as young as three months of age, reflects the significant unmet medical need that exists for safe and effective therapies for children suffering from atopic dermatitis.”
