Positive Topline Results from Phase 2 Clinical trial of Thykamine™

The Phase 2 trial was a double‐blind, randomized, placebo‐controlled trial designed to evaluate the efficacy and safety of Thykamine™ cream monotherapy (0.05%, 0.1% and 0.25%) compared to placebo in skin clearance as assessed by the Investigator Global Assessment (IGA) in adult patients with mild-to-moderate atopic dermatitis. Efficacy and safety were assessed every week over a four-week dosing treatment (twice-a-day). A total of 162 patients, spread over several sites in Canada, were recruited for this study.

Compared to placebo, Thykamine™ at 0.1% demonstrated significant improvement of the primary endpoint, i.e. skin clearance (IGA) at all measured timelines (week 1: p = 0.006; week 2: p < 0.001; week 3: p < 0.001; Week 4: p=0.002) resulting in demonstrating a fast onset of the therapeutic effect.

In addition, Thykamine™ achieved statistically significant differences, compared to placebo, in its key secondary efficacy endpoint, i.e. Body Surface Area (BSA). Thykamine™ at doses of 0.05% and 0.1% demonstrated statistically significant results of BSA after 2 weeks, (p=0.036 and p=0.001 respectively), 3 weeks (p=0.02 and 0.002 respectively) and 4 weeks (p=0.04 and p=0.004 respectively) of therapy.

Thykamine™ was shown to be safe and well tolerated during the study with no Thykamine™-related adverse events (AEs) reported.

"We are very pleased with the results of this Phase 2 study, which underscores our belief in the potential for Thykamine™ to provide a better solution for patients with mild-to-moderate atopic dermatitis," said Dr André P. Boulet, President and CEO of Devonian. "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 have now results demonstrating the anti-inflammatory efficacy of Thykamine™ in two distinct disorders and two different modes of administration. Indeed, Thykamine™ efficacy and safety, as enema treatment, was demonstrated in patients with distal mild-to-moderate Ulcerative Colitis (UC) after only 14 days of treatment. The results of the Atopic Dermatitis trial showed a fast onset of action as seen in the Ulcerative Colitis trial." added Dr Boulet.