Arcutis Biotherapeutics’ topical cream has racked up a second phase 3 win in eczema patients, putting the company on track to file for FDA approval in the indication in the second half of next year.
Last month, Arcutis presented data from its first phase 3 clinical trial in patients with mild to moderate atopic dermatitis, revealing that 32% of participants in the treatment arm scored “clear” or “almost clear” and had a two-grade improvement on a disease scale after four weeks of treatment. With 15.2% of patients in the vehicle control group achieving such improvement, the study hit its primary endpoint.
Now, Arcutis has returned with data from its second phase 3 trial. The sibling study randomized 683 patients to use a cream containing 0.15% roflumilast, the PDE4 inhibitor in AstraZeneca’s oral therapy Daliresp or a vehicle control for four weeks.
At the end of the initial treatment period, 28.9% of people in the roflumilast cream arm met the success criteria—the same endpoint used in the other phase 3—compared to 12% of individuals treated with the vehicle. The difference caused the study to meet its primary endpoint. The control-adjusted success rate in the two phase 3 studies is almost identical.
The second clinical trial met key secondary endpoints too, linking roflumilast cream to improvements on the Eczema Area and Severity Index and an itch scale. Arcutis powered the trial to try to hit secondary endpoints and boost its prospects of securing the broad label it wants to make a dent on the market.
Arcutis, which has already brought roflumilast to market in plaque psoriasis as Zoryve, sees reasons to think it can force its way into the competitive atopic dermatitis market, as CEO Todd Watanabe outlined on a quarterly results conference call with investors last month.
“We see a very large unmet need in atopic dermatitis in spite of all the recent progress. It's a very large and rapidly growing market. I think Dupixent is a very good drug, and you've got some newer options coming along as well, but even with those innovations less than half of patients are able to achieve the 75% improvement in their disease,” Watanabe said.
Arcutis plans to file for approval of roflumilast cream in atopic dermatitis in adults and children aged 6 years and up in the second half of next year. The company also aims to publish top-line data from a phase 3 trial that is testing the drug candidate in children aged 2 to 5 years in 2023.