Benzinga | Mar 18, 2021 09:09AM EDT

Arcutis Announces First Patient Enrolled In Phase 2a Clinical Trial Evaluating ARQ-252 As A Potential Treatment For Vitiligo

* ARQ-252 is a potent and highly selective topical JAK1 inhibitor offering potential safety advantages over less selective JAK inhibitors

* Topline data anticipated second half 2023

* Vitiligo affects approximately 1.3 million patients in the U.S.

WESTLAKE VILLAGE, Calif., March 18, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced enrollment of the first patient in a Phase 2a clinical trial evaluating ARQ-252 as a potential treatment for vitiligo. ARQ-252 is a potent and highly selective topical small molecule inhibitor of Janus kinase type 1 (JAK1).

"Initiation of this clinical trial marks an important milestone toward addressing the unmet need for new treatments for a chronic skin disease that can negatively impact a patient's quality of life," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "Approximately 1.3 million people in the U.S. suffer from vitiligo, and there is currently no FDA-approved treatment. Physicians typically use off-label combinations of older agents, but these options generally lead to only limited improvement, and most patients are dissatisfied with their treatment options. Early data with other topical JAK inhibitors suggest this target is effective in treating vitiligo, and 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. This Phase 2a study will evaluate ARQ-252 in combination with at-home narrowband UVB phototherapy, and it is our hope that this approach can provide meaningfully better efficacy to patients with this very challenging condition."

This Phase 2a study is a parallel group, double blind, vehicle-controlled study of the safety and efficacy of ARQ-252 0.3% cream either with or without narrowband UVB (NB-UVB) phototherapy treatment in approximately 500 subjects with non-segmental facial vitiligo. The primary endpoint of the study is the proportion of subjects achieving Facial Vitiligo Area Scoring Index-75 (F-VASI-75), which is ? 75% improvement from baseline in F-VASI at week 24.

Arcutis is also developing ARQ-252 0.3% cream as a potential treatment for chronic hand eczema and expects to report topline data from a Phase 1/2b study in mid-2021. In October 2020, Arcutis announced that enrollment had been completed in this Phase 1/2b study to assess the safety and efficacy of ARQ-252 0.1% cream once daily and ARQ-252 0.3% cream once daily or twice daily versus vehicle applied once daily or twice daily for 12 weeks to patients with chronic hand eczema.