Roflumilast foam advances to Phase 3

Data show that roflumilast foam provides significant improvement for seborrheic dermatitis

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Roflumilast foam advances to Phase 3

WESTLAKE VILLAGE, Calif.—Arcutis Biotherapeutics, a late-stage biopharmaceutical company focused on immune-mediated dermatological diseases, has reported that the company plans to advance its topical roflumilast foam (ARQ-154) as a treatment for seborrheic dermatitis into Phase 3. This announcement comes after an end-of-Phase 2 meeting with the FDA.

“Following our interactions with the FDA, we are delighted to advance topical roflumilast foam into Phase 3 development for the treatment of seborrheic dermatitis,” said Dr. Patrick Burnett, chief medical officer of Arcutis. “If successful in the Phase 3 clinical trial and approved for commercialization, roflumilast foam has the potential to become the standard of care in seborrheic dermatitis.”

Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor. The Phase 3 program will consist of a single pivotal trial, which Arcutis says the company will initiate in the second or third quarter of 2021.

“Patients are desperate to find new treatment options for seborrheic dermatitis, a common, chronic skin disease affecting the face and scalp that can profoundly affect patients’ appearance and quality of life,” noted Dr. Matthew Zirwas, founder of Bexley Dermatology Research Clinic and an investigator in the trial. “Dermatologists and patients face a real challenge, with current treatment options that are either safe or effective, but rarely both.”

PDE4 has been implicated in a wide range of inflammatory diseases, including psoriasis, eczema, and chronic obstructive pulmonary disease (COPD). PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for topical treatment of atopic dermatitis, and for the systemic treatment of plaque psoriasis. Roflumilast itself has been approved by the FDA since 2011, for systemic treatment to reduce the risk of COPD exacerbation.

“The foam is designed to deliver treatment more effectively to all areas of the body, and especially hair-bearing areas of the body, in patients with seborrheic dermatitis or scalp psoriasis,” states Frank Watanabe, president and CEO of Arcutis. “Roflumilast ... has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. We have also generated intriguing preclinical data suggesting roflumilast foam may have anti-fungal properties in addition to its anti-inflammatory properties, which is important because seborrheic dermatitis is thought to be caused by an over-colonization of yeast on the skin.”

“Notably, data generated to date suggest roflumilast foam is as effective or more effective than currently approved treatments, but with a better safety and tolerability profile. Additionally, it is a cosmetically elegant foam that can be used chronically in multiple locations without the burning and stinging associated with other treatment options,” he adds. “Unlike creams and ointments, roflumilast foam is suitable for use in hair-bearing areas; unlike steroids, it is expected to be suitable for long-term use, including on the face; and unlike shampoos, it is an elegant, quick-drying, leave-in foam that doesn’t need to be rinsed out.”

“Roflumilast foam is non-steroidal ... which is preferable especially for the face and around the eyes, due to the risks associated with skin thinning, stretch marks, or spider veins, as well as ocular steroid exposure, [which can lead] to glaucoma or cataracts,” explains Watanabe.

In Arcutis’ recently completed Phase 2 study, once-daily roflumilast foam demonstrated statistically significant improvement over the vehicle foam on the trial’s primary endpoint—Investigator Global Assessment success. The therapy also achieved multiple secondary endpoints, including reduction of itch.

Other than a small change in formulation, roflumilast foam is identical to roflumilast cream (ARQ-151)—Arcutis’ investigational topical cream PDE4 inhibitor—which has demonstrated both symptomatic improvement and a favorable tolerability profile in clinical trials in plaque psoriasis, including chronic psoriasis treatment, as well as encouraging results in atopic dermatitis.

“Both formulations—roflumilast foam and cream—offer physicians and patients highly differentiated clinical profiles that are ideally suited to address unmet needs … Topical roflumilast has the potential to provide a new standard care for the more than 5 million patients who suffer from these serious skin diseases and are treated with topical therapies by dermatologists,” Watanabe continues.

“Once-daily roflumilast foam is being developed as a standalone therapy offering the convenience of a single product, which has the potential to decrease the overall number of products used and therefore increase patient compliance. Currently, no single product works effectively on both scalp and face/body, leading to many patients being forced to use two or more different products in a treatment regimen,” he points out. “While roflumilast is being developed as a standalone offering, we believe its favorable safety and tolerability profile would also make it appropriate for combination therapy.”

“We’re most excited about the promise of topical roflumilast, which we believe will elevate the standard of care in medical dermatology by simplifying disease management for physicians and eliminating the need to compromise between drug safety, efficacy, and tolerability for patients,” Watanabe concludes, adding that “topical roflumilast foam is an outstanding example of Arcutis’ unique ability to harness the evolving science in inflammation and immunology to develop highly differentiated products that address the unmet needs of dermatologists and their patients.”

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