Arcutis Biotherapeutics has begun phase 3 clinical trials of its topical roflumilast cream in patients with atopic dermatitis. The product consists of the active ingredient in AstraZeneca’s oral lung drug Daliresp formulated into a cream for use on the skin of patients with a common form of eczema.
Roflumilast is a PDE4 inhibitor. In the context of chronic obstructive pulmonary disease, the condition treated by Daliresp, targeting PDE4 inhibits inflammation and relaxes airway muscle. Other researchers have identified overactive PDE4 enzymes as drivers of skin conditions, leading Pfizer and Amgen to go after the target with treatments for atopic dermatitis and plaque psoriasis.
Arcutis’ candidate is targeting the same market as Pfizer’s Eucrisa. Like Eucrisa, Arcutis’ ARQ-151 is a topical formulation of a PDE4 inhibitor designed for use in patients with mild-to-moderate atopic dermatitis.
While Arcutis has ceded a head start to its larger rival, it thinks ARQ-151 can come from behind as it has potential advantages over Eucrisa. Arcutis said roflumilast is more potent than the PDE4 inhibitor in Eucrisa, crisaborole, and came through early clinical tests without causing the application site burning associated with the Pfizer product.
Arcutis is now putting ARQ-151 through its toughest test yet. Across two identical phase 3 trials, Arcutis will randomize around 1,300 patients aged six years and up with mild-to-moderate atopic dermatitis to apply ARQ-151 or a control cream once a day for four weeks. The study is designed to show the effect of the drug on scores on an atopic dermatitis investigator assessment scale.
With the two trials getting underway, Arcutis expects to have top-line data in the second half of next year. Arcutis is also preparing a third phase 3 clinical trial that will evaluate ARQ-151 in patients aged two to five years.
The late-phase program will also serve as a test of Arcutis’ broader strategy. By hiring staff with experience developing topical formulations and getting them to work on clinically validated targets, Arcutis thinks it can advance dermatology assets that improve on existing products while spending less money and time on R&D as is typical.