Roflumilast Foam (ARQ-154)

Roflumilast foam (ARQ-154) is being investigated for the treatment of seborrheic dermatitis and scalp psoriasis.

  • Roflumilast foam, 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 has innovative, fast-breaking properties to promote delivery of active drug
  • Importantly, 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
  • Roflumilast foam is being investigated to address unmet needs for potential long-term treatment of affected body surfaces, including facial, periocular, hair-bearing, and other areas where creams may not be suitable

Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis

Landscape

  • Seborrheic dermatitis typically appears as erythematous patches on the scalp and face1
  • Seborrheic dermatitis is associated with itch, flaking, and reduced quality of life1,2
  • Treatments include topical antifungals and corticosteroids for the face and body and medicated shampoos for the scalp1
  • Treatment may require an alternative formulation (eg, foam) suitable for hair-bearing areas

Mechanism

  • Roflumilast is a selective, highly potent, anti-inflammatory phosphodiesterase 4 (PDE4) inhibitor that is being investigated for the reduction of itching and flaking of the skin
  • Foam formulation is being investigated for use on all areas of the body, including hair-bearing areas
Skin around eyes with seborrheic dermatitis.

Development

Phase 2 study is complete (NCT04091646)

Infographic showing eligibility, 8 week dosing, and endpoints of phase 2 study.

aIGA success was defined as IGA score of 0 or 1 (clear or almost clear) with at least a two-grade improvement from baseline.
BSA, body surface area; DLQI, Dermatology Life Quality Index; IGA, Investigator's Global Assessment; QD, once daily; WI-NRS, Worst Itch Numeric Rating Scale.



Graph of phase 2 long term safety study.
aThe first time point after the start of roflumilast treatment was week 2.
AE, adverse event; CI, confidence interval; IGA, Investigator's Global Assessment; TEAE, treatment-emergent adverse event; WI-NRS, Worst Itch Numeric Rating Scale.

A phase 2 long-term safety study of roflumilast foam in patients with seborrheic dermatitis is ongoing (NCT04445987)

Phase 3 study to initiate in Q2 or Q3 2021

Roflumilast Foam (ARQ-154) in Scalp Psoriasis

Landscape

  • Scalp psoriasis is characterized by silvery white scales and is often the first manifestation of psoriasis on the body3
  • Scalp psoriasis is associated with reduced quality of life from itching and embarrassment3
  • Many topical formulations may be difficult to apply directly to hair-bearing areas or may make the appearance of hair unacceptable3
  • Treatment may require a formulation (eg, foam) suitable for hair-bearing areas

Mechanism

  • PDE4 activity is elevated in psoriatic skin4
  • Roflumilast is a highly potent, anti-inflammatory, antipruritic PDE4 inhibitor
  • Foam formulation is being investigated use on all areas of the body, including hair-bearing areas
Skin at the hairline with scalp psoriasis.

Development

Phase 2b is complete (NCT04128007)

Infographic showing eligibility, 8 week dosing, and endpoints of phase 2b study.
aS-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.
Graph of phase 2b complete study.
aIGA success was defined as scores of 0 or 1 (clear or almost clear) with at least a 2-grade improvement from baseline.
AE, adverse event; B-IGA, Body Investigator's Global Assessment; S-IGA, Scalp Investigator's Global Assessment; SI-NRS, Scalp Itch Numeric Rating Scale.

References

1. Clark et al. Am Fam Physician. 2015;91:185-190. 2. Araya et al. Indian J Dermatol. 2015;60:519. 3. Merola et al. Dermatol Ther. 2018;31:e12589. 4. Li et al. Front Pharmacol. 2018;9:1048. 5. Zirwas et al. Presented at the Presented at the American Academy of Dermatology Annual Meeting, April 23-25, 2021; Virtual. 6. Data on file, Arcutis Biotherapeutics. 7. Kircik et al. Presented at the Presented at the American Academy of Dermatology Annual Meeting, April 23-25, 2021; Virtual.

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