Arcutis Biotherapeutics announced Aug. 25 that it has enrolled the first patient in a Phase 3 clinical trial to evaluate ARQ-154, its topical foam, as a treatment for scalp and body psoriasis.
The foam is a once-daily formulation of roflumilast, a phosphodiesterase type 4 inhibitor that the company is developing to treat two skin conditions: seborrheic dermatitis and scalp and body psoriasis.
Scalp and body psoriasis causes itching and pain and affects more than 8 million people in the U.S., according to an Arcutis news release.
“One challenge for patients with scalp psoriasis is that they often require two or more medications for different areas of the body to manage their disease,” said Dr. Patrick Burnett, Arcutis’ chief medical officer. “In our previous Phase 2b trial, roflumilast foam was demonstrated to be a safe, well-tolerated, and effective potential treatment for scalp and body psoriasis. We are pleased to initiate this Phase 3 trial, as we believe roflumilast foam, if approved, may represent a much-needed, new standard of care for people with scalp and body psoriasis that is suitable for use in hair-bearing areas, unlike creams and ointments, and does not pose the safety concerns typically seen with topical steroids.”
The new Phase 3 study will include around 420 subjects age 12 and older. Based on prior discussions with the U.S. Food and Drug Administration, Arcutis believes that if this trial is successful, it will provide sufficient basis for a new drug application for ARQ-154 for scalp and body psoriasis.
The trial is the third new Phase 3 trial Arcutis has started in 2021, with each one expected to conclude in 2022, CEO Frank Watanabe said in the company’s news release.