Arcutis Completes Enrollment in Phase 1/2b Study Evaluating ARQ-252 in Chronic Hand Eczema

• ARQ-252 is a potent and highly selective topical JAK1 inhibitor offering potential safety advantages over less selective JAK inhibitors
  
• Hand eczema is the most common skin disease affecting the hands, impacting more than 8 million Americans
• Topline data now anticipated by mid-2021
  

WESTLAKE VILLAGE, Calif., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that it completed enrollment in its Phase 1/2b study of ARQ-252, a potent and highly selective topical small molecule inhibitor of Janus kinase type 1 (JAK1), in adult patients with chronic hand eczema. Arcutis has updated its projections and now anticipates announcing topline data from this trial by mid-2021.

“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,” said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer. “More than eight million people in the U.S. 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.”

In April, Arcutis began the Phase 1 portion of this Phase 1/2b study to 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. The Company expects to report topline data by mid-2021.