Arcutis Biotherapeutics: Zoryve foam treatment resulted in major improvements

Arcutis Biotherapeutics (ARQT) announced that the Journal of American Medical Association Dermatology published the results from a pivotal Phase 3 study evaluating the efficacy and safety of ZORYVE foam 0.3% as a once-daily monotherapy treatment for psoriasis of the scalp and body. The study showed that treatment with investigational ZORYVE foam resulted in significant improvements across multiple efficacy endpoints, including the co-primary efficacy endpoints of S-IGA Success and B-IGA Success, as well as key secondary endpoints. The data also show improvement in pruritus was observed as early as 24 hours after the first application. A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis, was a Phase 3, randomized, double-blinded, vehicle-controlled trial which enrolled 432 adults and adolescents aged 12 years and older with plaque psoriasis affecting the scalp and body, across 49 sites in the United States and Canada. Significantly greater proportions of individuals treated with ZORYVE foam 0.3% achieved the co-primary efficacy endpoints of S-IGA Success and B-IGA Success, defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement from baseline. At Week 8, 66.4% of individuals treated with ZORYVE foam 0.3% achieved S-IGA success compared to 27.8% for vehicle. At Week 8, 45.5% of patients treated with ZORYVE foam achieved B-IGA success compared to 20.1% for vehicle. Other key findings include: ZORYVE foam provided a clinically meaningful improvement in scalp itch. 65.3% of individuals treated with ZORYVE achieved a clinically significant reduction in itch compared to 30.3% of individuals treated with vehicle at Week 8 as measured by a greater than or equal to 4-point change from baseline in Scalp Itch-Numeric Rating Scale. Significant improvement was seen in the ZORYVE treatment group as early as Week 2. The data also demonstrated improvement in body itch as measured by the Worst Itch-Numeric Rating Scale at Week 8, with 63.1% of those treated with ZORYVE foam 0.3% achieving a greater than or equal to 4-point reduction in WI-NRS compared to 30.1% of those treated with vehicle. Significant improvement was seen in the ZORYVE treatment group as early as Week 2. The most frequent adverse events in the ZORYVE foam arm included headache, diarrhea, and nausea. Investigator-rated application-site tolerability was similar between ZORYVE and vehicle groups, with investigators reporting no evidence of irritation for at least 99.2% of all patients at all time points. Patient-rated application-site tolerability was also similar between ZORYVE and vehicle with at least 94.4% of patients reporting no or mild sensation on local tolerability assessments at all time points.