Roflumilast foam (ARQ-154)
Overview
Roflumilast foam (ARQ-154) is being investigated for the treatment of scalp and body psoriasis.
Roflumilast foam 0.3%, which has a similar composition to roflumilast cream (ARQ-151), is uniquely formulated as an emollient, water-based (~65% water) foam without fragrances, propylene glycol, isopropyl alcohol, or ethanol, and is designed with innovative, fast-breaking properties to promote delivery of active drug. It contains an exclusive emulsifier designed to maintain epidermal intercellular lipids and is adjusted to a stratum corneum pH at which the skin normally functions.
scalp and body psoriasis
Roflumilast foam (ARQ-154) in scalp and body psoriasis.
Clinical landscape
- Many topical formulations may be difficult to apply directly to hair-bearing areas or may make the appearance of hair unacceptable1
- Scalp psoriasis is characterized by silvery white scales and is often the first manifestation of psoriasis on the body1
- Treatment may require a formulation (eg, foam) suitable for hair-bearing areas
Proposed MOA
- PDE4 activity is elevated in psoriatic skin2
- Roflumilast is a highly potent,* anti-inflammatory, antipruritic PDE4 inhibitor3
- Foam formulation is being investigated for the treatment of scalp and body psoriasis
*In vitro data. Clinical efficacy claims cannot be made.
MOA = mechanism of action
Clinical programs
Phase 3
ARRECTOR, a pivotal phase 3 study of roflumilast foam 0.3%, has been completed in patients with scalp and body psoriasis.
ClinicalTrials.gov identifier: NCT05028582
Study design summary4
||S-IGA Success and B-IGA Success were defined as scores of 0 or 1 (Clear or Almost Clear) with at least a 2-grade improvement from baseline.
**SI-NRS Success was defined as a ≥4-point improvement from baseline in SI-NRS score in patients with a baseline SI-NRS score of ≥4.
††WI-NRS Success was defined as a ≥4-point improvement from baseline in WI-NRS pruritus score in patients with a baseline WI-NRS pruritus score of ≥4.
B-IGA = Body Investigator’s Global Assessment, BSA = body surface area, CFB = change from baseline, PASI = Psoriasis Area and Severity Index, PSD = Psoriasis Symptom Diary, PSSI = Psoriasis Scalp Severity Index, QD = once daily, S-IGA = Scalp Investigator’s Global Assessment, SI-NRS = Scalp Itch Numeric Rating Scale, WI-NRS = Worst Itch Numeric Rating Scale.
Phase 2
A phase 2b study of roflumilast foam 0.3% in patients with scalp and body psoriasis has been completed.
ClinicalTrials.gov identifier: NCT04128007
Study design summary5
‡‡S-IGA Success and B-IGA Success were defined as scores of 0 or 1 (Clear or Almost Clear) with at least a 2-grade improvement from baseline.
B-IGA = Body Investigator’s Global Assessment, BSA = body surface area, PSSI = Psoriasis Scalp Severity Index, QD = once daily, S-IGA = Scalp Investigator’s Global Assessment, WI-NRS = Worst Itch Numeric Rating Scale.
References
1. Merola et al. Dermatol Ther. 2018;31:e12589. 2. Li et al. Front Pharmacol. 2018;9:1048. 3. Dong et al. J Pharmacol Exp Ther. 2016;358:413-422. 4. Data on File, Arcutis Biotherapeutics, Inc. 5. Kircik et al. Presented at the American Academy of Dermatology Annual Meeting; April 23-25, 2021; Virtual.