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
Rhea-AI Summary
Devonian Health Group (OTCQB: DVHGF) received Health Canada authorization to initiate a seamless adaptive Phase II/III clinical trial of PUR 0110 (Thykamine™) cream in pediatric patients with mild-to-moderate atopic dermatitis, covering the full intended age range from 3 months to 17 years.
The 12-week, randomized, double-blind, placebo-controlled study will enroll approximately 306 patients, testing 0.05% and 0.1% Thykamine™ cream versus placebo. The primary endpoint is Week 12 treatment success based on vIGA-AD (Clear/Almost Clear with ≥2-grade improvement). An independent safety committee will oversee adverse events, age-cohort progression, and a Phase II futility analysis to determine seamless transition to Phase III.
According to Devonian, this pediatric program builds on a prior adult Phase II trial in atopic dermatitis where Thykamine™ showed statistically significant efficacy and an excellent safety profile, and is supported by a global patent portfolio for the Thykamine™ and SUPREX™ platforms.
Positive
- Health Canada authorization for pediatric Phase II/III Thykamine™ trial in AD
- Full pediatric age range approved, from 3 months to 17 years
- Planned enrollment of 306 patients across Phase II and III
- Prior adult Phase II trial showed statistically significant efficacy and favorable safety
- Global patent portfolio covering Thykamine™ and SUPREX™ in North America, Europe, Asia
Negative
- None.
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- 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.
- Devonian believes Thykamine™ has the potential to provide an important new non-steroidal therapeutic option for pediatric patients requiring long-term disease management.
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 3 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
Dr. Lynde is Medical Director of the Lynde Institute for Dermatology in
The study will be conducted through a network of leading dermatology centers 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 (
The study is designed to evaluate both the efficacy and safety of two concentrations of Thykamine™ cream (
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. 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 II: 102 patients
Phase III: an additional 204 patients
Patients will be randomized equally to receive:
Thykamine™ Cream
Thykamine™ Cream
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 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. This endpoint represents a rigorous and clinically meaningful measure of disease improvement and is consistent with endpoints 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 (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.
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 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, 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
Devonian believes 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.
Management Commentary
Dr. André 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 honored that this important clinical program will be led by Dr. Charles Lynde, one of
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."
Reference
- Watson W, Kapur S. Atopic Dermatitis. Allergy, Asthma & Clinical Immunology, 7(Suppl 1):S4, 2011
- Tian J, Zhang D, Yang Y, et al. Global epidemiology of atopic dermatitis: a comprehensive systematic analysis and modelling study. Br J Dermatol 00:1–7, 2023.
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, 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
About Devonian
Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune 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 Health Group Inc. 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 (the "Exchange") (TSXV: GSD) and currently quoted on the OTCQB Venture Market (OTCQB: DVHGF).
For more information, visit www.groupedevonian.com
Cautionary Note Regarding Forward-Looking Statements
All statements contained in this press release, other than statements of historical fact, including, but not limited to, statements relating to the Company's transition toward a focused biopharmaceutical development strategy centered on Thykamine™; the anticipated conduct, timing, enrollment, execution and potential outcomes of its Health Canada-authorized Phase II/III clinical trial evaluating Thykamine™ for the treatment of pediatric atopic dermatitis; the Company's radiodermatitis prevention Prospective Performance clinical study; the advancement of its preclinical programs; the potential hepatoprotective effects of Thykamine™ in preventing the progression of metabolic dysfunction-associated steatohepatitis (MASH); its anti-inflammatory and anti-fibrotic properties and their potential to address the underlying pathology of fibrotic diseases; the potential clinical efficacy, safety profile, commercial prospects and regulatory pathway of Thykamine™; the significance of the Health Canada authorization in supporting the continued clinical development of Thykamine™; the Company's ability to successfully complete clinical development and obtain future regulatory approvals; and, generally, the statements contained under the "About Devonian" section, constitute "forward-looking information" or "forward-looking statements" within the meaning of applicable securities laws (collectively, "forward-looking statements"). These forward-looking statements are based on the Company's current expectations, estimates and assumptions as of the date of this press release. Such forward-looking statements may be identified by the use of words such as "anticipates," "believes," "expects," "intends," "plans," "may," "could," "would," "should," "will," or similar expressions, including negative or grammatical variations thereof, indicating that certain actions, events or results may, could or will occur or be achieved. The authorization by Health Canada to conduct the Phase II/III clinical trial permits the Company to initiate the study but does not constitute an endorsement of Thykamine™, nor does it represent a determination by Health Canada regarding the product's safety or efficacy, or any assurance that the study will achieve its endpoints or that future regulatory approval will be obtained.
Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management's expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Company disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law.
Neither the Exchange nor its Regulation Services Provider (as that term is defined in policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release.
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SOURCE Devonian Health Group Inc.