Positive Topline Data from Phase 2b Study of Roflumilast Foam for Scalp and Body Psoriasis

Arcutis Biotherapeutics, Inc., a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, shared positive top line data from a Phase 2b clinical trial evaluating ARQ-154 (topical roflumilast foam) as a potential treatment for scalp psoriasis.

Roflumilast foam 0.3% administered once daily for 8 weeks demonstrated statistically significant improvements compared to a matching vehicle foam on key efficacy endpoints in 304 adult and adolescent patients with plaque psoriasis that included plaques on the scalp. On the study’s primary endpoint of Scalp Investigator Global Assessment (S-IGA) success assessed at week 8, roflumilast foam 0.3% achieved a rate of 59.1 percent compared to a vehicle rate of 11.4 percent (p<0.0001). S-IGA success is defined as the achievement of an S-IGA score of 'clear' or 'almost clear' on a 5-grade scale plus at least a two-point change from baseline. Onset was rapid, with significantly higher rates of S-IGA success noted as early as 2 weeks.

Multiple secondary endpoints were also met. On the key secondary endpoint of Body Investigator Global Assessment (B-IGA) success assessed at week 8, roflumilast foam 0.3% achieved a rate of 40.3 percent compared to a vehicle rate of 6.8 percent (p<0.0001), with separation from vehicle on B-IGA success as early as 2 weeks. Symptomatic improvement was also demonstrated, with 71.0% of subjects treated with roflumilast foam 0.3% who had a baseline Scalp Itch Numeric Rating Scale (SI-NRS) score of 4 or greater achieving an itch reduction of at least 4 points at week 8 compared to 18.5 percent of vehicle treated subjects (p<0.0001). Consistent with other clinical trials of topical roflumilast, roflumilast foam was well-tolerated, as evidenced by subject-reported local tolerability and rates of application site adverse events, treatment-related adverse events, and discontinuations due to adverse events low and similar to vehicle. Only 5 out of 200 subjects (2.5 percent) in the roflumilast foam treated group discontinued the study due to an adverse event, compared to 2 out of 104 subjects (1.9 percent) treated with the vehicle.

“Scalp psoriasis inflicts a high burden for patients, and current treatment options often carry significant treatment limitations that result in poor outcomes and can have a negative impact on patient quality of life,” says Leon Kircik, MD, Clinical Professor of Dermatology, Icahn School of Medicine at Mount Sinai, Indiana University Medical Center, and Medical Director, Physicians Skin Care, DermResearch, and Skin Sciences. “Roflumilast once-daily foam demonstrated rapid and significant improvements in psoriasis signs and symptoms, including reducing itch in a meaningful way. These positive results are encouraging for patients and clinicians who are desperate for new treatments that can simplify disease management, can be used in all areas of the body, and can ultimately improve the patient experience.”

“Approximately 40 percent of the 6 million Americans afflicted with active, chronic psoriasis have scalp involvement, an area where treatment of scalp plaques is complicated by the difficulty of delivering topical drugs under the hair and to the surface of the skin,” adds Linda F. Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, as well as Division Head of Dermatology at Henry Ford Health System in West Bloomfield, Michigan. “Novel treatments are needed, particularly ones like topical roflumilast foam that have the potential to be safe for chronic use; that are appropriate for application in hair-bearing areas where a cream, lotion, or ointment is not suitable; and that have demonstrated symptomatic improvement similar to high-potency steroids while also maintaining a favorable safety and tolerability profile. I believe these data demonstrate that once daily roflumilast foam could offer patients the efficacy and tolerability that they need. In my opinion, if approved, topical roflumilast foam has the potential to become an important treatment option for plaque psoriasis patients, particularly those with scalp involvement.”

“We are delighted with these data, in which topical roflumilast foam demonstrated meaningful symptomatic improvement, alongside a favorable safety and tolerability profile that supports chronic use,” said Patrick Burnett, MD, PhD, FAAD, and Chief Medical Officer of Arcutis. “With once-a-day dosing, roflumilast foam potentially offers the convenience of a simple, single, non-steroidal solution for both scalp and non-scalp plaques. If successful in Phase 3 clinical trials and approved for commercialization, roflumilast foam will be the first novel mechanism of action for the treatment of scalp and body psoriasis in decades. We believe it has the potential to positively affect the symptoms and quality of life of the millions of patients who suffer from this distressing chronic skin condition.”