Phase 2 Trial of Topical Thykamine in Adults With Mild to Moderate Atopic Dermatitis

October 2022 | Volume 21 | Issue 10 | 1091 | Copyright © October 2022


Published online September 29, 2022

doi:10.36849/JDD.6729

Charles Lynde MDa, Yves Poulin MDb, Jerry Tan MDc, Mark Lomaga MD PhDd, Wei-jing Loo MDe, Diane Carbonneau MDf, Isabelle Delorme MDg, Doria Grimard MDh, John Sampalis PhDi

aLynde Dermatology, Probity Medical Research, and Department of Medicine, University of Toronto, Toronto, ON, Canada
bCentre de Recherche Dermatologique du Québec, Quebec City, Quebec, Canada
cWindsor Clinical Research Inc., Windsor, Ontario, Canada
dDermEdge Research Inc., Mississauga, Ontario, Canada
eDermEffects, London, Ontario, Canada
fCentre de Recherche Saint-Louis, Quebec City, Quebec, Canada
gDr. Isabelle Delorme Inc., Drummondville, Quebec, Canada
hQ&T Research Chicoutimi, Chicoutimi, Quebec, Canada iMcGill University, Montreal, Quebec, Canada

Abstract
Background: Atopic dermatitis is a common skin disorder for which there remains an unmet need for topical pharmacotherapies that are safe and effective. This phase 2 study assessed the efficacy and safety of 3 dosages of PUR 0110 (Thykamine; Devonian Health Group Inc.) cream (0.05%, 0.1%, and 0.25%) compared to vehicle for treatment of adults with mild to moderate atopic dermatitis. The primary efficacy endpoint was the proportion of patients with an Investigator’s Global Assessment (IGA) of clear/almost clear and with a decrease from baseline score of at least 2 grades at day 29. Key secondary efficacy endpoints included change from baseline to day 29 in IGA, percent body surface area (%BSA) affected, Eczema Area and Severity Index (EASI) score, pruritus, and quality of life. Safety outcomes included the incidence of local and systemic adverse events. The primary efficacy endpoint was met with PUR 0110 cream 0.10% compared to vehicle (30.8% vs 6.7%, respectively, P=.014). Most secondary endpoints also favored PUR 0110 cream 0.10% vs vehicle, including change from baseline to day 29 in IGA score, %BSA affected, pruritus, and patient-reported quality of life. Adverse events occurred at a similar rate in all treatment groups; most were mild to moderate in intensity and were infrequently associated with study withdrawal. PUR 0110 cream 0.10% demonstrated rapid improvement in signs and symptoms of atopic dermatitis. This observation, along with its favorable safety and tolerability profile, could make it a useful therapeutic option for the treatment of atopic dermatitis.

J Drugs Dermatol. 2022;21(10):1091-1097. doi:10.36849/JDD.6729

INTRODUCTION

Atopic dermatitis (AD) is a chronic, relapsing inflammatory disease involving epidermal skin barrier dysfunction, genetic predisposition, and immune dysregulation.1,2 Recent advances in the understanding of the pathophysiology of AD implicate a strong contribution of T helper (Th) 2 inflammation and dysregulation in Th17 and Th22 pathways, particularly during the acute phase, with a transition towards Th1 activation during the chronic phase.1,3 Atopic dermatitis is one of the most common skin disorders with an estimated lifetime prevalence of 10%-20%.4,5 Although the disease most commonly develops during the first year of life and often improves in late childhood, it can manifest at any age and its prevalence in adults has been estimated at 2%-10%.4,6 Intense pruritus, xerosis, and eczematous lesions are hallmark clinical features of AD.4,6 The disease has been associated ith substantial personal burden including itch and pain that can contribute to sleep disturbances and impaired cognitive function,7 diminished quality of life,8 reduced psychosocial wellbeing,8,9 and stigma related to visible lesions,4,8 as well as societal burden due to high direct10 and indirect costs.11 The disease severity is mild to moderate in 80%-95% of cases depending on the assessment measure used.5

The mainstay for the management of mild to moderate AD is topical therapies, including non-pharmacologic modalities (eg, moisturizers, emollients, basic hygiene measures) and pharmacologic agents (eg, topical corticosteroids [TCS], topical calcineurin inhibitors [TCI], and phosphodiesterase-4 [PDE-4] inhibitors).12,13 At this time, none of the approved topical pharmacologic therapies are approved for continuous long-
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