Arcutis Biotherapeutics, Inc. has completed enrollment in the Phase 1/2b studyof its Janus kinase type 1(JAK1) ARQ-252 in adult patients with chronic hand eczema. Arcutis has updated its projected topline data from this trial to mid-2021.
Arcutis began the Phase 1 portion of this Phase 1/2b study in April. The study will assess the safety, tolerability, and pharmacokinetics of once daily application of ARQ-252 cream 0.3% to both hands for two weeks in seven subjects with chronic hand eczema. In July, the Company began the Phase 2b portion of the study to assess the safety and efficacy of ARQ-252 cream 0.1% once daily and ARQ-252 cream 0.3% once daily or twice daily versus vehicle applied once daily or twice daily for 12 weeks to patients with chronic hand eczema. Enrollment of the Phase 2b portion is now complete with 223 subjects.
“We were pleased with the speed with which this trial enrolled, underscoring the high unmet need for new treatments to treat this chronic skin disease that can cause significant skin irritation and discomfort and can have a negative impact on a patient’s quality of life,” says Patrick Burnett, MD, PhD, FAAD, Arcutis’ Chief Medical Officer. “More than eight million people in the US suffer from hand eczema, and patients often have to make trade-offs between drug efficacy, safety, and tolerability with current available treatments. ARQ-252 has demonstrated robust potency and high selectivity for JAK1 over JAK2, thereby giving it the potential to deliver efficacy without causing the side effects typical of other less selective JAK inhibitors. Given this, we believe ARQ-252 has the potential to reduce the need to compromise between safety and efficacy.”