Roflumilast Cream (ARQ-151)

Roflumilast cream (ARQ-151) is being investigated for the treatment of atopic dermatitis.

  • Roflumilast cream is uniquely formulated as an emollient, water-based (~48% water) cream without fragrances, propylene glycol, isopropyl alcohol, or ethanol
  • Roflumilast cream contains an exclusive 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 0.15% and 0.05% in patients with atopic dermatitis

Roflumilast Cream (ARQ-151) in Atopic Dermatitis

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

Mechanism

  • Elevated PDE4 levels are found in the keratinocytes of individuals with atopic dermatitis3
  • Inhibition of PDE4 decreases inflammatory response and pruritus3,4
  • Roflumilast cream (ARQ-151) is a selective, highly potent5* PDE4 inhibitor being investigated as a treatment for atopic dermatitis
  • *In vitro data. Clinical efficacy claims cannot be made.
Skin with atopic dematitis.

Clinical Program Results

A phase 2 study has been completed (NCT03916081)6

Infographic showing eligibility, 4 weeks dosing, and endpoints of phase 2 study.

BSA, body surface area; EASI, Eczema Area and Severity Index; EASI-50, Eczema Area and Severity Index 50% improvement; EASI-75, Eczema Area and Severity Index 75% improvement; QD, once daily; vIGA-AD, Validated Investigator’s Global Assessment for Atopic Dermatitis; WI-NRS, Worst Itch Numeric Rating Scale.

Two phase 3 studies (INTEGUMENT-1/-2) are ongoing for roflumilast cream in atopic dermatitis (NCT04773587 and NCT04773600)7

Infographic showing eligibility, 4 week dosing, and endpoints of phase 3 studies.

aIGA success was defined as a score of 0 or 1 (clear or almost clear) with at least a 2-grade improvement from baseline.
EASI-75, Eczema Area and Severity Index 75% improvement; IGA, Investigator's Global Assessment; QD, once daily; vIGA-AD, Validated Investigator's Global Assessment for Atopic Dermatitis; WI-NRS, Worst Itch Numeric Rating Scale.

A phase 3 trial of roflumilast cream 0.05% in pediatric patients aged 2-5 years is ongoing (INTEGUMENT-PED: NCT04845620)

A phase 3 long-term study is ongoing (INTEGUMENT-OLE: NCT04804605)

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. 6. Gooderham et al. Presented at: 29th European Academy of Dermatology and Venereology Congress; October 29-31, 2020; Virtual. 7. Data on file, Arcutis Biotherapeutics.

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