Announcement • Jul 21
Devonian Health Group Receives Health Canada Authorization to Initiate Phase Ii/Iii Pediatric Clinical Trial of Thykamine for Mild-To-Moderate Atopic Dermatitis in Patients Aged 3 Months to 17 Years
Devonian Health Group Inc. has received Health Canada authorization to initiate its Phase II/III clinical study evaluating PUR 0110 (Thykamine) cream for the treatment of mild-to-moderate atopic dermatitis in pediatric patients. The primary objective of the study is to evaluate the efficacy of Thykamine compared with placebo in the treatment of mild-to-moderate pediatric atopic dermatitis after 12 weeks of twice-daily treatment. Secondary objectives include assessment of the overall safety and tolerability. The trial will employ a seamless adaptive Phase II/III design, incorporating an interim analysis following completion of Phase II to allow a seamless transition into the confirmatory Phase III portion of the program. Health Canada authorized the study in the full intended pediatric population, including infants from 3 months of age through adolescents 17 years of age. The clinical trial will be led by Dr. Charles Lynde, MD, FRCPC, DABD, who will serve as the Principal Investigator. The study will be conducted through a network of dermatology centers with expertise in pediatric dermatology and clinical research. The Health Canada-authorized study is entitled: "A 12-Week Multicenter, Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of Two Concentrations (0.05% and 0.1%) of PUR 0110 (Thykamine) Cream Applied Twice Daily in Pediatric Patients with Mild-to-Moderate Atopic Dermatitis." The study is designed to evaluate both the efficacy and safety of two concentrations of Thykamine cream (0.05% and 0.1%) compared with placebo cream in pediatric patients with mild-to-moderate atopic dermatitis. The trial employs a seamless adaptive Phase II/III design, incorporating an interim analysis following completion of Phase II to allow a seamless transition into the confirmatory Phase III portion of the program. Approximately 306 pediatric patients will be enrolled in the study: Phase II: 102 patients; Phase III: an additional 204 patients. Patients will be randomized equally to receive Thykamine Cream 0.05%, Thykamine Cream 0.1%, or placebo cream. The primary efficacy endpoint is the proportion of patients achieving treatment success at Week 12, defined as a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of Clear (0) or Almost Clear (1), with an improvement of at least two grades from baseline. Secondary objectives include assessment of the overall safety and tolerability of both Thykamine concentrations. They are designed to comprehensively characterize the clinical benefits of Thykamine by evaluating the speed and durability of treatment response, improvements in disease severity, reduction in affected body surface area, patient-reported symptoms, and health-related quality of life and safety over the 12-week treatment period using validated clinical and patient-reported outcome measures. Patient safety will be closely monitored throughout the study by an independent Data Safety Monitoring Committee (DSMC). During Phase II, the DSMC will conduct ongoing unblinded reviews of all reported adverse events and will have the authority to recommend study termination at any time should safety concerns arise. The study will proceed with sequential enrolment of two age cohorts. First, 69 patients between the ages of 2 and 17 years will be enrolled. The second cohort will comprise 33 patients between the ages of 3 months and 2 years. Recruitment in the second cohort will proceed only after approval from the DSMC, informed by pre-specified stopping rules; the final decision to continue enrolment in the second cohort will be based on the overall clinical judgment of the DSMC. Upon completion of Phase II, the DSMB will also perform a formal futility assessment and determine whether the study should seamlessly progress into the Phase III portion of the clinical program. The pediatric program builds upon Devonian's previously completed randomized Phase II clinical trial in adults with mild-to-moderate atopic dermatitis. In that study, Thykamine cream demonstrated statistically significant clinical efficacy together with an excellent safety profile, supporting advancement into pediatric development. Thykamine has also demonstrated an excellent safety profile across multiple clinical studies involving different formulations and routes of administration. Atopic dermatitis is one of the most common chronic inflammatory skin diseases affecting children worldwide. Approximately 60% of patients develop symptoms during the first year of life, and up to 85% develop the disease before five years of age. Persistent itching, inflammation and disruption of the skin barrier can significantly impair quality of life for children and their families while increasing the risk of recurrent skin infections and sleep disturbances. Thykamine's unique botanical mechanism of action, combined with its favorable safety profile demonstrated to date, has the potential to provide an important new non-steroidal therapeutic option for pediatric patients requiring long-term disease management. Thykamine, the first pharmaceutical product issued from Devonian's SUPREX platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a large Phase II study in adult patients with mild-to-moderate Atopic Dermatitis. The Thykamine and SUPREX technology platforms are supported by a patent portfolio with issued patents spanning key markets in North America, Europe, and Asia.
