Arcutis Enrolls First Patient in Phase 1b Alopecia Areata Study Evaluating ARQ-255

Rhea-AI Summary

Arcutis Biotherapeutics (Nasdaq: ARQT) has announced the enrollment of the first subject in a Phase 1b study for ARQ-255, a new topical JAK1 inhibitor designed for alopecia areata treatment. This formulation utilizes proprietary 4D technology to deliver the drug deep into the skin, targeting the hair follicle's inflammation. Alopecia areata affects approximately 1 in 500 adults, causing sudden hair loss and emotional distress. The study will focus on the safety and tolerability of ARQ-255 in healthy volunteers and those with patchy alopecia areata.

Positive

• Enrollment of the first subject in the Phase 1b study for ARQ-255, indicating progress in clinical development.
• ARQ-255 leverages proprietary 4D technology for enhanced drug delivery deep into the skin, targeting inflammation effectively.

Negative

• None.

• ARQ-255 is a topical janus kinase (JAK) inhibitor therapy specifically designed as a potential treatment for alopecia areata
• Proprietary Deep Dermal Drug Delivery (4D) formulation designed to deliver drug deep into the skin to the base of the hair follicle where key alopecia areata inflammation occurs

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.

About ARQ-255
ARQ-255, or topical invarmactiniib suspension, is a topical janus kinase 1 (JAK1) inhibitor therapy for alopecia areata. Topical treatment of alopecia areata is challenging due to the depth of inflammation and the dense vasculature that surrounds the hair bulb. ARQ-255 has been uniquely formulated to deliver drug deeper into the skin than conventional topical formulations, to reach the site of inflammation 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 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 harnesses 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 psoriasis, atopic dermatitis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and Twitter.

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 potential for ARQ-255 as a treatment for alopecia areata. 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, the impact of competition and other important factors discussed in the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 22, 2022, as amended, 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:
Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

FAQ

What is ARQ-255 and its purpose?

ARQ-255 is a topical JAK1 inhibitor designed to treat alopecia areata by targeting inflammation at the hair follicle.

What is the current status of the ARQ-255 clinical trial?

The first subject has been enrolled in a Phase 1b study evaluating the safety and tolerability of ARQ-255.

When was the first subject enrolled in the ARQ-255 study?

The first subject was enrolled in the Phase 1b study on December 5, 2022.

What does the Phase 1b study for ARQ-255 involve?

The study is vehicle-controlled, double-blind, and multicenter, focusing on the safety, tolerability, and pharmacokinetics of ARQ-255.

What is alopecia areata and how prevalent is it?

Alopecia areata is an autoimmune condition that affects about 1 in 500 adults, causing patches of hair loss.