Devonian Health Group Inc. announced the publication of Thykamine™ positive phase 2 trial in adult patients with mild-to-moderate Atopic Dermatitis (AD) in the peer-reviewed Journal of Drugs in Dermatology. This article, titled ‘‘Phase 2 Trial of Topical Thykamine in Adults with Mild to Moderate Atopic Dermatitis'' has been published in a JDD special issue focus on Atopic Dermatitis (J Drugs Dermatol 21(10): 1091-1097, October 2022). The paper by Lynde et al.

discloses the results of the Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial conducted in 162 adult patients with mild-to-moderate AD. In this 4-week multicentre study, a significantly greater proportion of adult patients treated with Thykamine™ cream 0.10% achieved an IGA of clear/almost clear and at least a 2-grade improvement from baseline in IGA (30.8%) compared to placebo (6.7%; P =.014). The benefit of Thykamine™ cream 0.10% was supported by a statistically significant effect on secondary endpoints of Body Surface Area (BSA), pruritis, and Patient-Oriented Eczema Measure score (POEM).

A significant reduction in %BSA affected from baseline was demonstrated at all study visits. These changes differentiated significantly from placebo from Day 14 until Day 29 (p = 0.001). Pruritus (‘‘itch'') was rapidly improved from baseline by Day 7 with a statistically difference vs placebo at Day 21 and Day 29 (p = 0.01).

POEM outcome was statistically significant from placebo at day 21 and 29 (p = 0.01). Thykamine™, at all doses, was well tolerated with an adverse event profile like placebo. 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 disease and its prevalence continues to increase worldwide. In the United States, the incidence has been reported to be 15-30% of children. 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. 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 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.