Arcutis Biotherapeutics has delivered a phase 3 win for its roflumilast foam formulation. With the cream version already under review at the FDA in plaque psoriasis, the topical drug delivery specialist has now gathered up the data to support a filing for the foam variant in seborrheic dermatitis.
Investigators randomized 457 subjects with the skin condition seborrheic dermatitis to receive a foam formulation of roflumilast, the PDE4 inhibitor found in AstraZeneca’s oral chronic obstructive pulmonary disease treatment Daliresp, or placebo. At week eight, 80.1% of subjects treated with the experimental foam had experienced IGA success, defined as a two grade or greater improvement from baseline, compared to 59.2% of their peers in the control group.
More than half of participants on roflumilast had an IGA clear score at week eight. Divergence between the treatment and placebo groups on the IGA scores began at week two. Arcutis also claimed success on secondary endpoints that looked at variables including itch, scaling and redness. Almost two-thirds of the patients on the foam experienced an itch response, versus 42% of their peers on placebo.
Based on feedback from the FDA, Arcutis thinks the single study can support approval in the indication. A filing for approval is planned for the first half of 2023. Arcutis filed for approval of its roflumilast cream in patients with plaque psoriasis last year, giving it a PDUFA action date of July 29. If approved in seborrheic dermatitis, Arcutis thinks the foam will gain access to 2.2 million patients in the U.S.
“This is an underappreciated opportunity,” Arcutis CEO Frank Watanabe said on a call with investors to discuss the data. “There are as many seborrheic dermatitis patients in the dermatologist's office receiving topical treatment as there are psoriasis patients. There is a very significant unmet need. It's a very unusual thing and a very needed thing to have a nonsteroidal that can be used chronically and anywhere on the body. That's a very significant development.”
Based on the tolerability profile seen in the trial and other studies, Arcutis doesn’t expect to receive a boxed warning from the FDA. Arcutis also expects to find patients are open to trying new treatment regimens.