Topical roflumilast to move to phase 3 trials for atopic dermatitis

Arcutis Biotherapeutics will begin phase 3 trials of ARQ-151 for the treatment of atopic dermatitis, according to a press release.

ARQ-151 (topical roflumilast cream) will move into pivotal phase 3 clinical trials in late 2020 or early 2021 following an end-of-phase 2 meeting with the FDA, the release said.

“Results from previous clinical trials have shown that our simple, easy-to-use, once-a-day topical roflumilast cream provided efficacy results similar to those seen with topical JAK inhibitors or mid-potency steroids while also being well tolerated, which is critical in children,” Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, said in the release. “By delivering efficacy that enables meaningful symptomatic improvement and a favorable safety and tolerability profile that supports chronic use for patients with atopic dermatitis, topical roflumilast has the potential to overcome the significant shortcomings of existing therapies, which could mitigate the need for dermatologists and patients to make trade-offs in efficacy, safety and tolerability.”

The once-daily phosphodiesterase type 4 inhibitor topical cream is also being developed for the treatment of psoriasis.