Botanical pharmaceutical company Devonian Health Group has reported that its Phase II study of Thykamine for treating mild-to-moderate atopic dermatitis (AD) met the primary endpoint.
A pharmaceutical product issued from Devonian’s SUPREX platform, Thykamine is an innovative product for the prevention and treatment of conditions linked to inflammation and oxidative stress.
The double‐blind, randomised, placebo‐controlled trial analysed the efficacy and safety of Thykamine cream monotherapy (0.05%, 0.1% and 0.25%) versus placebo in skin clearance as assessed by the Investigator Global Assessment (IGA) in adult patients with mild-to-moderate AD.
The trial enrolled 162 subjects at several sites in Canada, and efficacy and safety were evaluated weekly over a four-week dosing treatment (twice-a-day).
According to the results from the study, Thykamine at 0.1% showed significant improvement in skin clearance versus placebo at all measured timelines, thereby meeting the primary endpoint. It showed a fast onset of the therapeutic effect.
Furthermore, Thykamine achieved statistically significant differences in Body Surface Area (BSA), a crucial secondary efficacy endpoint, versus placebo.
Data showed that Thykamine at doses of 0.05% and 0.1% showed statistically significant results of BSA after two, three and four weeks of the treatment.
The therapy was observed to be safe and well-tolerated with no adverse events (AEs) in the study.
Devonian Health Group president and CEO Dr André Boule said: “These results bring into focus the exciting opportunity for Thykamine, with the possibility of improving immuno-related skin diseases and serious immuno-inflammatory diseases, for which there remains a great unmet need for new treatment options.
“We now have results demonstrating the anti-inflammatory efficacy of Thykamine in two distinct disorders and two different modes of administration.”
The company noted that the efficacy and safety profile support progressing into Phase III trial in adult patients with mild-to-moderate AD, as well as a clinical trial in the paediatric population with mild-to-moderate AD.