Arcutis Completes Phase 1b Enrollment for ARQ-255 Alopecia Areata Study

Arcutis Biotherapeutics, Inc., a company specializing in immuno-dermatology, has announced the completion of subject enrollment for its Phase 1b study of ARQ-255. ARQ-255 is a topical suspension of ivarmacitinib, a potent and selective Janus kinase 1 (JAK1) inhibitor, formulated with Arcutis' proprietary Deep Dermal Drug Delivery (4D) technology. This technology enables the drug to penetrate deeply into the skin, reaching the base of the hair follicle where inflammation associated with alopecia areata occurs.

Patrick Burnett, MD, PhD, FAAD, and chief medical officer at Arcutis, emphasized the significance of this development. He noted that approximately one in 500 people are affected by alopecia areata, a condition for which no FDA-approved topical treatments currently exist. Burnett highlighted that data from this initial human study will provide essential insights into the safety, tolerability, and pharmacokinetics of ARQ-255, aiding in its clinical development and potentially bringing innovative solutions to immune-mediated skin conditions that have seen little progress over the years.

The Phase 1b study is a vehicle-controlled, double-blind, multi-center trial designed to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of ARQ-255 in healthy adult volunteers and individuals with patchy alopecia areata. A total of 44 participants are involved in the study, and results are anticipated in the first half of 2025.

ARQ-255 presents a unique approach to treating alopecia areata due to its ability to deliver medication deep into the skin, specifically targeting the inflammation at the base of the hair follicles. This approach addresses the challenge posed by the depth of inflammation characteristic of alopecia areata.

Alopecia areata is an autoimmune disorder that results in hair loss, affecting about one in 500 adults across various ages, sexes, and ethnic groups. The condition arises when the immune system attacks hair follicles, leading to sudden bald patches on the scalp, face, and other body areas. These patches can sometimes escalate to involve the entire body. Recurrence is common, and many patients experience multiple episodes throughout their lives.

Arcutis Biotherapeutics, Inc., listed on Nasdaq as ARQT, is a commercial-stage company focused on advancing dermatological treatments for immune-mediated diseases. The company's portfolio includes three FDA-approved products and a robust pipeline targeting conditions such as scalp and body psoriasis, atopic dermatitis, and alopecia areata. The company's dermatology development platform leverages its expertise to create differentiated therapies aimed at biologically validated targets.

Arcutis remains committed to addressing the unmet needs of patients suffering from dermatological conditions through innovative solutions and is keen on advancing its clinical programs to offer better treatment options. The results of the ARQ-255 Phase 1b study are highly anticipated as they could pave the way for a significant breakthrough in the treatment of alopecia areata, a condition that has long lacked effective topical therapeutic options.

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