Roflumilast cream (ARQ-151)

Overview

Roflumilast cream 0.05% (ARQ-151) is being investigated for the treatment of atopic dermatitis in patients aged 2-5.

Roflumilast cream is uniquely formulated as an emollient, water-based (~48% water) cream without fragrances, propylene glycol, isopropyl alcohol, or ethanol. It contains a novel emulsifier designed to maintain epidermal intercellular lipids and is adjusted to a stratum corneum pH at which the skin normally functions. Ongoing clinical trials are investigating roflumilast cream and 0.05% in patients aged 2-5 with atopic dermatitis.

Atopic dermatitis

Roflumilast cream (ARQ-151) in atopic dermatitis.

Clinical landscape

Atopic dermatitis is a common, chronic inflammatory skin disease affecting both children and adults¹
Itch is the most burdensome symptom, causing patients to experience substantially reduced quality of life and sleep disturbances²
The skin barrier is typically compromised in atopic dermatitis³
Topical corticosteroids and emollients are the standard of care³
Steroids are not suitable for long-term use, and children are at risk of greater systemic absorption³

Proposed MOA

Elevated PDE4 levels are found in the keratinocytes of individuals with atopic dermatitis³
Inhibition of PDE4 decreases inflammatory response and pruritus^3,4
Roflumilast cream 0.05% (ARQ-151) is a selective, highly potent^* PDE4 inhibitor being investigated as a treatment for atopic dermatitis in patients aged 2-5.⁵

*In vitro data. Clinical efficacy claims cannot be made.

MOA = mechanism of action

Clinical programs

Phase 3

A phase 3 trial of roflumilast cream 0.05% in pediatric patients aged 2-5 years is ongoing (INTEGUMENT-PED).

ClinicalTrials.gov identifier: NCT04845620

View Study Details

References

1. Bieber. Ann Dermatol. 2010;22:125-137. 2. Silverberg et al. Ann Allergy Asthma Immunol. 2018;121:340-347. 3. Nygaard et al. Dermatology. 2017;233:333-343. 4. Bäumer et al. Inflamm Allergy Drug Targets. 2007;6:17-26. 5. Dong et al. J Pharmacol Exp Ther. 2016;358:413-422.