Devonian Health Group Inc. announced the acceptance for publication of results from its positive phase 2 trial of Thykamine™ in patients with mild-to-moderate Atopic Dermatitis (AD) in the peer-reviewed Journal of Drugs in Dermatology (JDD). This JDD article, titled ``Phase 2 Trial of Topical Thykamine™ in Adults with Mild to Moderate Atopic Dermatitis'' will be published in a special issue on Atopic Dermatitis planned for October 2022. The Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted in 162 patients with mild-to-moderate AD.

In this 4-week, multicentre study, adult patients were randomized to receive ThykamineTM cream 0.05%, 0.10%, 0.25% or vehicle cream (placebo) twice daily. The primary efficacy endpoint was the Investigator Global Assessment (IGA) success rate defined as percentage of patients with an IGA score of 0 or 1 with greater than or equal to 2-grade reduction at week 4. Secondary endpoints included body surface area (BSA), pruritus and the Patient-Oriented Eczema Measure (POEM), among others. The benefit of Thykamine™ cream 0.10% was supported by a statistically significant effect on the primary and secondary endpoints of Body Surface Area (BSA), pruritis, and Patient-Oriented Eczema Measure score (POEM).

Atopic Dermatitis or eczema,is a chronic inflammatory disease of the skin that is recurrent. It is characterized by itchy, red, swollen and cracked skin that may lead to secondary infections. 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 disease4 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 year5.

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).

There is currently an enormous unmet need for new, effective, and well-tolerated treatment options in AD8. The global atopic dermatitis market is expected to exceed USD 21,8 billion in sales by 2027. ThykamineTM, 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 phase II clinical study in patients with mild-to- moderate atopic dermatitis. Both Thykamine™ and SUPREX™ platform are protected by several patents in North America, Europe and Asia. Devonian Health Group Inc. (Devonian) is a late-stage botanical pharmaceutical corporation with novel therapeutic approaches to targeting unmet medical needs.

Devonian's core strategy is to develop prescription botanical drugs from plant materials and algae for the treatment of inflammatory-autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian's focus is further supported by a US-FDA set of regulatory guidelines favouring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines. Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings.