Arcutis Completes Enrollment of Phase 1b Alopecia Areata Study Evaluating ARQ-255
Arcutis Biotherapeutics (Nasdaq: ARQT) has completed enrollment for its Phase 1b study of ARQ-255, a topical JAK1 inhibitor for alopecia areata. The study, involving 44 participants, aims to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of ARQ-255 in healthy adults and those with patchy alopecia areata. ARQ-255 utilizes Arcutis' proprietary Deep Dermal Drug Delivery (4D) technology to target inflammation at the hair follicle base. This innovation addresses a significant unmet need, as alopecia areata affects approximately 1 in 500 people with no FDA-approved topical treatments currently available. Results from this first-in-human study are expected in the first half of 2025, potentially advancing treatment options for this immune-mediated skin condition.
Arcutis Biotherapeutics (Nasdaq: ARQT) ha completato l'arruolamento per il suo studio di Fase 1b su ARQ-255, un inibitore topico di JAK1 per l'alopecia areata. Lo studio, che coinvolge 44 partecipanti, ha l'obiettivo di valutare la sicurezza, la tollerabilità, la farmacodinamica e la farmacocinetica di ARQ-255 in adulti sani e in quelli con alopecia areata a chiazze. ARQ-255 utilizza la tecnologia proprietaria di Arcutis, Deep Dermal Drug Delivery (4D), per mirare all'infiammazione alla base dei follicoli piliferi. Questa innovazione risponde a un'esigenza significativa, poiché l'alopecia areata colpisce circa 1 persona su 500, e attualmente non ci sono trattamenti topici approvati dalla FDA. I risultati di questo studio di prima in umani sono attesi nella prima metà del 2025, con il potenziale di avanzare le opzioni di trattamento per questa condizione della pelle mediata dal sistema immunitario.
Arcutis Biotherapeutics (Nasdaq: ARQT) ha completado la inscripción para su estudio de Fase 1b sobre ARQ-255, un inhibidor tópico de JAK1 para la alopecia areata. El estudio, que involucra a 44 participantes, tiene como objetivo evaluar la seguridad, la tolerabilidad, la farmacodinamia y la farmacocinética de ARQ-255 en adultos sanos y en aquellos con alopecia areata en parches. ARQ-255 utiliza la tecnología patentada de Arcutis, Deep Dermal Drug Delivery (4D), para dirigirse a la inflamación en la base del folículo piloso. Esta innovación aborda una necesidad importante, ya que la alopecia areata afecta aproximadamente a 1 de cada 500 personas, sin tratamientos tópicos aprobados por la FDA actualmente disponibles. Se espera que los resultados de este primer estudio en humanos se hagan públicos en la primera mitad de 2025, lo que podría avanzar las opciones de tratamiento para esta condición de piel mediada por el sistema inmune.
Arcutis Biotherapeutics(Nasdaq: ARQT)는 ARQ-255에 대한 1b상 연구의 참여자 모집을 완료했습니다. 이는 탈모증 환자를 위한 국소 JAK1 억제제입니다. 본 연구는 44명의 참가자를 포함하며, 건강한 성인과 패치형 탈모증 환자에서 ARQ-255의 안전성, 내약성, 약리학적 동태 및 약물동태를 평가하는 것을 목표로 합니다. ARQ-255는 Arcutis의 독점 기술인 Deep Dermal Drug Delivery (4D) 기술를 활용하여 모낭의 염증을 표적합니다. 이 혁신은 탈모증이 약 500명 중 1명에게 영향을 미치는 중대한 미충족 요구 사항을 해결합니다. 현재 FDA에서 승인된 국소 치료가 없는 상태입니다. 이 첫 번째 인체 연구의 결과는 2025년 상반기에 발표될 예정이며, 이는 면역 매개 피부 상태의 치료 옵션을 발전시킬 수 있습니다.
Arcutis Biotherapeutics (Nasdaq: ARQT) a terminé le recrutement pour son étude de Phase 1b sur ARQ-255, un inhibiteur topique de JAK1 pour l'alopecia areata. L'étude, impliquant 44 participants, vise à évaluer la sécurité, la tolérabilité, la pharmacodynamique et la pharmacocinétique de ARQ-255 chez des adultes en bonne santé ainsi que chez ceux présentant une alopecia areata en plaques. ARQ-255 utilise la technologie propriétaire d'Arcutis, Deep Dermal Drug Delivery (4D), pour cibler l'inflammation à la base des follicules pileux. Cette innovation répond à un besoin essentiel, car l'alopecia areata touche environ 1 personne sur 500, sans traitements topiques approuvés par la FDA disponibles actuellement. Les résultats de cette première étude chez l'homme sont attendus dans la première moitié de 2025, ce qui pourrait faire progresser les options de traitement pour cette affection cutanée médiée par le système immunitaire.
Arcutis Biotherapeutics (Nasdaq: ARQT) hat die Rekrutierung für seine Phase-1b-Studie zu ARQ-255, einem topischen JAK1-Inhibitor gegen Alopecia areata, abgeschlossen. Die Studie umfasst 44 Teilnehmer und hat zum Ziel, die Sicherheit, Verträglichkeit, Pharmakodynamik und Pharmakokinetik von ARQ-255 bei gesunden Erwachsenen und bei Personen mit fleckiger Alopecia areata zu bewerten. ARQ-255 nutzt die proprietäre Deep Dermal Drug Delivery (4D)-Technologie von Arcutis, um Entzündungen an der Basis der Haarfollikel anzugehen. Diese Innovation beantwortet ein signifikantes, ungelöstes Bedürfnis, da Alopecia areata ungefähr 1 von 500 Personen betrifft und es derzeit keine von der FDA zugelassenen topischen Behandlungen gibt. Die Ergebnisse dieser ersten Studie am Menschen werden in der ersten Hälfte des Jahres 2025 erwartet und könnten die Behandlungsoptionen für diesen immunvermittelten Hautzustand vorantreiben.
- Completed enrollment for Phase 1b study of ARQ-255 for alopecia areata
- Utilizes proprietary Deep Dermal Drug Delivery (4D) technology for targeted treatment
- Addresses unmet need in alopecia areata treatment with no current FDA-approved topical options
- Study results expected in first half of 2025, potentially advancing treatment options
- Results not expected until first half of 2025, indicating a long wait for potential market impact
- Early-stage clinical trial (Phase 1b) with no guarantee of success or FDA approval
Insights
The completion of enrollment in Arcutis' Phase 1b study for ARQ-255 marks a significant step in addressing the unmet need for topical treatments in alopecia areata. The study's focus on safety, tolerability and pharmacokinetics is important for establishing the foundation of ARQ-255's clinical development.
Key points to consider:
- The use of JAK1 inhibitors in dermatology is expanding and a topical formulation could offer a more targeted approach with potentially fewer systemic side effects.
- Arcutis' proprietary 4D technology, designed to deliver the drug to the base of hair follicles, could be a game-changer if it proves effective in clinical trials.
- With results expected in H1 2025, investors should be prepared for a wait before any potential market impact.
While promising, it's important to note that this is an early-stage study and success here doesn't guarantee FDA approval or commercial viability.
From a financial perspective, Arcutis' progress with ARQ-255 represents a potential expansion of their product pipeline in the immuno-dermatology space. However, investors should consider several factors:
- The alopecia areata market is competitive, with recent approvals of systemic JAK inhibitors from larger pharmaceutical companies.
- Development timelines are long; with results not expected until 2025, any revenue impact is years away.
- R&D costs for dermatological drugs can be substantial, potentially impacting Arcutis' cash burn rate.
While this news doesn't immediately affect Arcutis' financial position, successful development of ARQ-255 could significantly expand their addressable market in the long term. Investors should monitor the company's cash position and burn rate as development progresses.
- ARQ-255 is a topical Janus kinase 1 (JAK1) inhibitor suspension formulated as a potential topical treatment for alopecia areata
- Proprietary Deep Dermal Drug Delivery (4D) technology formulated to deliver drug deep into the skin to the base of the hair follicle where alopecia areata inflammation occurs
- Phase 1b results expected first half of 2025
WESTLAKE VILLAGE, Calif., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the enrollment of the last subject in the Phase 1b study evaluating ARQ-255, a topical suspension of ivarmacitinib, a potent and selective 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 affects approximately 1 in 500 people, yet today there are no FDA approved topical treatments for this devastating condition,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “The safety, tolerability, and pharmacokinetics data generated from this first-in-human study will provide valuable information to inform our ARQ-255 clinical development program and advance our vision of bringing innovation to the treatment of immune-mediated skin conditions where there has been little advancement in decades.”
The Phase 1b, vehicle-controlled, double-blind, multicenter study is evaluating the safety, tolerability, pharmacodynamics, and pharmacokinetics of ARQ-255 topical suspension or vehicle in healthy adult volunteers and individuals with patchy alopecia areata (n=44). Results from the study are expected to be reported in the first half of 2025.
About ARQ-255
ARQ-255, or topical ivarmacitinib suspension, is a topical JAK1 inhibitor therapy for alopecia areata. Topical treatment of alopecia areata is challenging due to the depth of inflammation. ARQ-255 has been uniquely formulated to deliver drug deeper into the skin to reach the site of inflammation at the base of the hair follicle in alopecia areata.
About 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.
About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including three FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X.
Forward-Looking Statements
Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the timing and potential for clinical results for ARQ-255 and for the continuation of the clinical development program. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, and the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts:
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Investors
Latha Vairavan, Vice President, Finance and Corporate Controller
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