Arcutis Biotherapeutics, Inc. plans to initiate its Phase 3 program of ARQ-151 as a potential topical treatment for plaque psoriasis following its End-of-Phase 2 meeting with the FDA. The Company anticipates initiating a Phase 3 clinical trial in the first half of 2020.

Frank Watanabe, Arcutis’ President and Chief Executive Officer, commented: “We appreciate the collaborative interaction with the FDA to reach agreement on the key elements of our Phase 3 program that we intend to use to support the submission of a New Drug Application for ARQ-151 for plaque psoriasis. Based on our clinical data to date, we believe ARQ-151 has the potential to be both a best-in-class topical PDE4 inhibitor and the only topical PDE4 inhibitor approved for plaque psoriasis. We look forward to starting our Phase 3 program in the first half of next year.”

The company also announced that it has completed enrollment of a 52-week Phase 2 long-term safety study of ARQ-151 in plaque psoriasis. Topline results are expected in the first half of 2021. The Company expects this study to supply the 12-month safety data required for regulatory submissions. In the previous Phase 2b trial in plaque psoriasis, both tested doses of ARQ-151 were well tolerated and demonstrated rapid onset of effect with statistically significant superiority over vehicle. ARQ-151 is a topical cream formulation of roflumilast, a highly potent and selective Phosphodiesterase type 4 (PDE4) inhibitor, which the Company is developing for once-a-day application to treat plaque psoriasis and atopic dermatitis.

The ARQ-151-202 study is a Phase 2, multi-center, open-label study of the long-term safety of ARQ-151 0.3% cream in adult subjects with chronic plaque psoriasis involving up to 25% total body surface area (BSA), evaluated in two cohorts: 231 patients who have completed the ARQ-151-201 Phase 2b, randomized, controlled trial; and 102 previously untreated subjects. The qualifying subjects will apply ARQ-151 0.3% cream once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression. The primary outcome measures of the study are the occurrence of treatment-emergent adverse events and the occurrence of serious adverse events.

Howard Welgus, Arcutis’ Chief Medical Officer, commented: “Because psoriasis is a chronic disease, it is critical to understand the efficacy, safety and tolerability of any new psoriasis treatment over an extended period. Thus, this long-term safety study is important to our understanding of ARQ-151’s potential to address the unmet needs in topical treatment of psoriasis. Furthermore, this strategic clinical development approach to generating long-term safety data allows our Phase 3 studies to be of shorter duration.”