Dr. Andre Boulet reports

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

Health Canada has authorized Devonian Health Group Inc.'s clinical trial application to initiate its phase 2/3 clinical study evaluating PUR 0110 (thykamine) cream for the treatment of mild to moderate atopic dermatitis in pediatric patients.

The authorization marks a significant regulatory milestone for Devonian and enables the company to commence one of the most comprehensive clinical development programs ever undertaken for a botanical prescription drug in pediatric atopic dermatitis.

Importantly, following a thorough scientific review, Health Canada authorized the study in the full intended pediatric population, including infants from three months of age through adolescents 17 years of age, supporting Devonian's objective of developing thykamine for the broad pediatric population affected by this chronic inflammatory skin disease.

World-renowned dermatology leadership

The clinical trial will be led by Dr. Charles Lynde, MD, FRCPC, DABD, one of Canada's most respected dermatologists and internationally recognized experts in inflammatory skin diseases, who will serve as the principal investigator.

Dr. Lynde is medical director of the Lynde Institute for Dermatology in Markham, Ont., associate clinical professor in the Division of Dermatology at the University of Toronto, and has served as principal investigator in numerous Canadian and international dermatology clinical trials. He has written more than 200 scientific publications, and is widely recognized for his expertise in atopic dermatitis, psoriasis and other chronic inflammatory skin diseases.

The study will be conducted through a network of leading dermatology centres with expertise in pediatric dermatology and clinical research.

About the clinical trial

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 per cent and 0.1 per cent) compared with placebo cream in pediatric patients with mild to moderate atopic dermatitis.

The trial employs a seamless adaptive phase 2/3 design, incorporating an interim analysis following completion of phase 2, to allow a seamless transition into the confirmatory phase 3 portion of the program. This innovative design is intended to optimize clinical development timelines while maintaining rigorous scientific and regulatory standards.

Approximately 306 pediatric patients will be enrolled in the study:

• Phase 2: 102 patients;
• Phase 3: an additional 204 patients.

Patients will be randomized equally to receive:

• Thykamine cream 0.05 per cent;
• Thykamine cream 0.1 per cent;
• Placebo cream.

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. The primary efficacy end point is the proportion of patients achieving treatment success at week 12, defined as a validated investigator's global assessment for atopic dermatitis score of clear (zero) or almost clear (one), with an improvement of at least two grades from baseline. This end point represents a rigorous and clinically meaningful measure of disease improvement, and is consistent with end points commonly used in pivotal atopic dermatitis clinical trials.

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.

Independent safety oversight

Patient safety will be closely monitored throughout the study by an independent data safety monitoring committee.

During phase 2, the DSMC will conduct continuing 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 two and 17 years will be enrolled. The second cohort will comprise 33 patients between the ages of three months and two years. Recruitment in the second cohort will proceed only after approval from the DSMC, informed by prespecified 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 2, the DSMB will also perform a formal futility assessment and determine whether the study should seamlessly progress into the phase 3 portion of the clinical program.

This independent oversight reflects Devonian's commitment to the highest standards of patient safety while maximizing the efficiency of clinical development.

Building upon positive adult clinical results

The pediatric program builds upon Devonian's previously completed randomized phase 2 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, further supporting its development as a novel botanical therapeutic platform.

Addressing a significant pediatric medical need

Atopic dermatitis is one of the most common chronic inflammatory skin diseases affecting children worldwide. Approximately 60 per cent of patients develop symptoms during the first year of life, and up to 85 per cent 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.

Devonian believes thykamine's unique botanical mechanism of action, combined with its favourable 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.

Management commentary

Dr. Andre P. Boulet, PhD, president and chief executive officer of Devonian Health Group, commented: "Receiving Health Canada's authorization to initiate this pediatric 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 authorization to study thykamine across the full pediatric 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.

"We are also particularly honoured that this important clinical program will be led by Dr. Charles Lynde, one of Canada's foremost dermatologists and internationally recognized experts in inflammatory skin diseases. His extensive clinical experience and scientific leadership will be invaluable as we advance thykamine through this development program.

"Based on the encouraging efficacy and excellent safety profile demonstrated in our previous clinical studies, we believe thykamine has the potential to become an important new botanical prescription therapy for pediatric atopic dermatitis and represents another significant step toward establishing Devonian as a leader in pharmaceutical innovation."

About thykamine

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, antioxidative 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 2a clinical study in patients with mild to moderate distal ulcerative colitis and in a large phase 2 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.

About Devonian Health Group Inc.

Devonian is a clinical-stage pharmaceutical company specializing in the development of drugs for various autoimmune fibroinflammatory disease with novel therapeutic approaches to targeting unmet medical needs. Devonian's core strategy is to develop prescription drugs for the treatment of fibroinflammatory autoimmune diseases, including, but not limited to, atopic dermatitis, radiodermatitis and ulcerative colitis.

Devonian was incorporated in 2015 and is headquartered in Quebec, Canada, where it owns a state-of-the-art extraction facility. Devonian is traded publicly on the TSX Venture Exchange and currently quoted on the OTCQB Venture Market.

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