DEVONIAN HEALTH GROUP INC.

 

PRESS RELEASE
For immediate release

NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

 

Devonian Announces Plans for its Dermatology program
of Thykamine.

 

QUEBEC, Québec – June 22, 2017 – Devonian Health Group Inc. (“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 (placebocontrolled)
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.

 

Contact:
Dr. André P. Boulet, PhD
President and Chief Executive Officer
Devonian Health Group inc.
Telephone: (514) 248-7509
Email: apboulet@groupedevonian.com
 
 
Références

  1. Peng W., Novak N. Pathogenesis of atopic dermatitis. Clinical et Experimental Allergy 2015, 45 :
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  2. 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.
  3. Silverberg JI, Simpson EL. Associations of childhood eczema severity : A US population based
    study. Dermatitis 2014; 25(3):107-114.
  4. Chaplin S. Guide to treatments used for atopic dermatitis in adults. Prescriber 2016 : 27(10): 30-
    39.
  5. 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