Arcutis Enrolls First Patient in Phase 1b Alopecia Areata Study Evaluating ARQ-255
WESTLAKE VILLAGE, Calif., Dec. 05, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the first subject has been enrolled in a Phase 1b study evaluating ARQ-255, a topical suspension of ivarmactinib, a potent and specific janus kinase 1 (JAK1) inhibitor, for the treatment of alopecia areata. ARQ-255 has been specifically formulated with Arcutis’ proprietary 4D technology to deliver drug deep into the skin to the base of the hair follicle, the site of the inflammation that underlies alopecia areata.
“Alopecia areata is an immune condition that not only causes hair loss, but also causes significant negative impact on an individual’s emotional and mental wellbeing. Today, there are no FDA-approved topical therapies to treat the condition,” said Frank Watanabe, President and CEO at Arcutis. “We are delighted to take this first step in the clinical development of ARQ-255, which leverages our unique 4D technology to deliver drug to the site of inflammation deep in the hair follicle.”
The phase 1b, vehicle-controlled, double-blind, multicenter study will evaluate the safety, tolerability, and pharmacokinetics of treatment with ARQ-255 topical suspension 3% or vehicle in healthy adult volunteers and individuals with patchy alopecia areata.
Alopecia areata is an autoimmune condition that affects about 1 in 500 adults and occurs in individuals of all ages, sexes, and ethnic groups. In alopecia areata, the immune system attacks the body’s own hair follicles—leading to the development of patches of hair loss (alopecia) on the scalp, face, and other areas of the body. Typically, these bald patches appear suddenly and in some patients can progress to involve the entire body. Recurrence is common and many patients will experience several episodes during their lifetime.
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