Arcutis Biotherapeutics Enrolls The First Participant In Phase 1a/1b Study (ARQ-234-131) To Evaluate Safety And Tolerability For Investigational Arq-234 In Healthy Volunteers And Adults With Moderate To Severe Atopic Dermatitis

Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the first participant has been enrolled in a Phase 1a/1b, double-blind, randomized, placebo-controlled study, ARQ-234-131, evaluating the safety and tolerability of ARQ-234. The investigational biologic, administered as a subcutaneous injection, is being evaluated in sequential cohorts, with single-ascending-dose cohorts in healthy volunteers and adults with moderate to severe atopic dermatitis, followed by multiple-ascending-dose cohorts and a small proof-of-concept cohort in the adults with atopic dermatitis.

ARQ-234 is a fusion protein designed to selectively activate the CD200 receptor (CD200R), an immune-regulatory checkpoint that helps regulate immune responses. By binding to CD200R, ARQ-234 is intended to reduce overactive immune responses and help restore balance.

"There is a significant opportunity to advance new treatments for moderate to severe atopic dermatitis that address the underlying immune dysregulation and provide long-term symptom control. We believe ARQ‑234 and its CD200R immune‑checkpoint agonist mechanism is a very promising pathway to address critical unmet needs," said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. "Our team's deep dermatology expertise and extensive biologics experience uniquely position us to progress this asset efficiently through early clinical development. Advancing ARQ-234 into the clinic reflects our continued commitment to expanding innovation for people living with this chronic condition."