QUÉBEC CITY, QUÉBEC–(Marketwired – June 22, 2017) –
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Devonian Health Group Inc. (TSX VENTURE:GSD) (“Devonian” or the “Corporation“) (TSXV: GSD) today announces key study design details for its planned Phase IIa clinical study of lead product candidate, Thykamine™, in patients with mild-to-moderate Atopic Dermatitis (AD). The Corporation also announces that JSS Medical Research Inc. has been selected as the Clinical Research Organization (CRO) to oversee its Phase IIa clinical study.
This will be a multicenter, randomized, double-blind, parallel-group, vehicle-controlled (placebo-controlled) study. Ninety-two (92) patients with mild-to-moderate AD will be included in this study. Eligible patients will be randomized to receive either one of 3 concentrations of Thykamine™ cream (0.05%, 0.1% and 0.25%) or vehicle (placebo). The cream will be applied twice a day to all AD affected areas of the skin excluding the palms, soles and scalp, for 28 days. The planned study start date is end of June 2017.
“Our clinical program involving Thykamine™ is expanding as this therapeutic product is moving into more advanced stages of clinical development. This Phase IIa study represents the first phase of our program targeting dermatological applications for this innovative botanical drug” said Dr. André P. Boulet, President & CEO of the Corporation.
“We are honored and excited that Devonian has selected JSS Medical Research as its partner in this innovative program. It is encouraging to see that novel, efficient and better tolerated treatments are emerging for chronic conditions, addressing an increasingly unmet need. As an academic clinical researcher and epidemiologist, I was impressed with the high standards and scientific rigor that Devonian has applied in the development of its therapeutic products and its leadership in transforming botanicals into pharmaceuticals. Furthermore, I am proud to be part of this initiative that is further testimony to the fact that Quebec and Canada are indeed major hubs for innovation and discovery in the health sciences” said Dr. John Sampalis, President & CSO of JSS Medical Research Inc.
About Atopic Dermatitis (AD)
Atopic dermatitis (AD), also known as eczema, is a type of inflammation of the skin. It results in itchy, red, swollen, and cracked skin. The condition typically starts in childhood with changing severity over the years. The cause is unknown but believed to involve genetics, a compromised immune system and environmental exposures. AD is the most common skin disease1. AD prevalence continues to increase worldwide. In the United States, prevalence has been reported to be 10-20% in children and new diagnoses at almost 11% per year2. The severity of AD can be categorized into mild, moderate and severe. The mild and moderate forms constitute approximately 67% and 26% respectively of the AD childhood patient population. A similar distribution has been reported in the adult patient population (71% and 26% respectively) 3,4. There is currently a high unmet need for new, effective and well-tolerated treatment options in AD5.
About Thykamine™
Thykamine™, the first pharmaceutical product issued from Devonian’s SUPREX™ platform is a highly innovative product to be used in the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, skin aging, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by an impressive 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. Thykamine™ is currently under development as treatment for ulcerative colitis and atopic dermatitis. Both Thykamine™ and SUPREX™ platform are protected by several patents in North America, Europe and Asia.
About Devonian
Devonian is a late stage botanical pharmaceutical corporation with novel therapeutic approaches targeting unmet medical needs. Devonian’s core strategy is to develop prescription botanical drugs. This strategy is supported by US-FDA set of regulatory guidelines favouring a more efficient drug development pathway versus traditional prescription medicines. Devonian is based on a broad-based platform originating from over ten years of research. This platform provides a unique process of extraction, purification, stabilization and conditioning of a molecular complex responsible for the photosynthetic process in plants and algae: The Supra Molecular Complex Extraction and Stabilisation Technology (SUPREX). “Thykamine™” is the first product issued from this platform. The potent anti-inflammatory and anti-oxidative activities of “Thykamine™” have been demonstrated in several pre-clinical experiments as well as in a clinical study in patients with mild-to-moderate distal ulcerative colitis. The product is now moving into large phase II clinical trials in two therapeutic areas: Ulcerative Colitis and Atopic Dermatitis. While the development of prescription botanical drugs is its core business, Devonian is also involved in the development of high value derma-cosmeceutical products as part of a secondary strategy to generate short-term revenues and optimize manufacturing efficiency.
For more information, visit www.groupedevonian.com.
About JSS Medical Research
JSS Medical Research is a full‐service International Contract Research Organization (CRO) with its corporate office in Montreal, Canada, and regional offices in Colombia, Poland and India. The company offers comprehensive clinical trial management services from study design to publication of results, in Phase I‐IV trials across a broad range of therapeutic areas. With science and clinical epidemiological expertise at its core and early phase services of the highest quality adhering to industry standards, JSS Medical Research is a leader in Post‐Approval Clinical Epidemiology Studies (PACES) including Post-Marketing Observational Studies, Health Outcomes Research (HEOR) and Health Economics. Currently. JSS Medical Research is conducting research studies in over 21 countries around the world for its clients that include the top 25 Pharmaceutical companies and Biotechnology/Device companies, worldwide.
For more information, visit www.jssresearch.com.
Forward Looking Statements
This press release contains forward-looking statements about Devonian’s objectives, strategies and businesses that involve risks and uncertainties. These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, Devonian’s ability to develop, manufacture, and successfully commercialize value-added pharmaceutical and dermo-cosmeceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Devonian to take advantage of business opportunities in the pharmaceutical and dermo-cosmeceutical industries, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in Devonian’s prospectus dated April 21st, 2017 under the heading “Risk Factors” related to Devonian’s business. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
References
- Peng W., Novak N. Pathogenesis of atopic dermatitis. Clinical et Experimental Allergy 2015, 45 : 566-574.
- Eichenfield F, Ellis CN, Mancini AJ, Paller AS, Simpsom EL. Atopic Dermatitis : Epidemiology and Pathogeneses Update. Semin Cutan Med Surg 2012, Sep; 31 (3 Suppl): S3-5.
- Silverberg JI, Simpson EL. Associations of childhood eczema severity : A US population based study. Dermatitis 2014; 25(3):107-114.
- Chaplin S. Guide to treatments used for atopic dermatitis in adults. Prescriber 2016 : 27(10): 30-39.
- Leung DYM. Guttman-Yassky E. Assessing the current treatment of atopic dermatitis: Unmet needs. J. of Allergy and Clinical Immunology. 2017; 139(4) Suppl. : S47-48
President and Chief Executive Officer
Devonian Health Group Inc.
(514) 248-7509
[email protected]
www.groupedevonian.com
