Devonian Announces Initiation of Phase IIa Clinical Trial of Thykamine™ in Adult patients with Mild-to-Moderate Atopic Dermatitis
- Category: Small Molecules
- Published on Thursday, 09 November 2017 16:25
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QUEBEC CITY, Canada I November 09, 2017 I Devonian Health Group Inc. ("Devonian" or the "Corporation") (TSX VENTURE:GSD), a clinical stage botanical pharmaceutical corporation, today announced the initiation of a Phase IIa clinical study to evaluate the tolerability, safety and efficacy ThykamineTM, in adult patients with mild-to-moderate Atopic Dermatitis (AD). Thykamine™ is an innovative product with anti-inflammatory, anti-oxidative and immunomodulatory properties for the prevention and treatment of several life-altering health conditions.
The randomized, double-blind, parallel-group, placebo-controlled study is being conducted at six (6) clinical centers in Canada. Eligible adult patients with mild-to-moderate AD will receive one of 3 concentrations of Thykamine™ cream (0.05%, 0.1% and 0.25%) or placebo. The cream will be applied twice a day for 28 days to all areas of the skin that are affected by atopic dermatitis, excluding the palms, soles of the feet and scalp. “This Phase IIa study represents the first milestone of our Atopic Dermatitis clinical development program,” said Dr. André P. Boulet, President & CEO of Devonian. “We then look forward to beginning clinical trials with pediatric patients where managing the itchy skin and scratching caused by mild to moderate eczema is particularly challenging for parents and physicians.”
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 that may lead to secondary infection. The condition typically starts in childhood with changing severity over the years. Although the cause of AD is unknown, it is believed to involve genetics, a compromised immune system and can be triggered by environmental factors. AD is the most common skin disease1.and its prevalence continues to increase worldwide. In the United States, the incidence has been reported to be 10-20% of children with new diagnoses at almost 11% per year2. The severity of AD can be categorized into three stages, 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.
ThykamineTM, the first pharmaceutical product issued from Devonian’s SUPREXTM 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 ThykamineTM 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. ThykamineTM is currently under development as treatment for ulcerative colitis and atopic dermatitis. Both ThykamineTM and SUPREXTM platforms are protected by several patents in North America, Europe and Asia.
Devonian is a clinical stage botanical pharmaceutical corporation with novel therapeutic approaches targeting unmet medical needs. Devonian's core strategy is to develop prescription botanical drugs. This focus is supported by a US-FDA set of regulatory guidelines favouring a more efficient drug development pathway versus those for traditional prescription medicines. Devonian is founded on a broad-based platform that spans more than fifteen years of research. Devonian’s proprietary process of extraction, purification, stabilization and conditioning of a molecular complex responsible for the photosynthetic process in plants and algae is known as: The Supra Molecular Complex Extraction and Stabilisation Technology (SUPREXTM). Thykamine™ is the first product derived from this platform. The potent anti-inflammatory and anti-oxidative active properties of Thykamine™ have been demonstrated in several pre-clinical studies 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.