Arcutis Biotherapeutics to Accelerate ARQ-151 (Topical Roflumilast Cream) into Phase 3 Trials for the Treatment of Atopic Dermatitis Following End-of-Phase 2 Meeting with FDA

Rhea-AI Summary

Arcutis Biotherapeutics has announced the advancement of its topical roflumilast cream to Phase 3 clinical trials for atopic dermatitis without conducting a Phase 2b trial following FDA discussions. Roflumilast cream, a selective PDE4 inhibitor, aims to offer a once-daily treatment option for approximately 20 million U.S. patients. Previous trials indicated its efficacy and tolerability are comparable to existing treatments. Topline data for plaque psoriasis trials is expected in early 2021, marking a significant step in developing innovative therapies for dermatological conditions.

Positive

• Progression to Phase 3 clinical trials indicates accelerated development for atopic dermatitis treatment.
• Previous clinical data showed favorable efficacy and tolerability for roflumilast cream.
• The drug has the potential to address unmet needs in atopic dermatitis and psoriasis treatments.

Negative

• None.

• Progression to Phase 3 clinical trials represents significant acceleration of atopic dermatitis development program
  
• Previously reported data demonstrated evidence that roflumilast cream provided symptomatic improvement and a favorable tolerability profile
• Roflumilast cream is a novel PDE4 inhibitor being developed as a once-daily topical cream for atopic dermatitis and psoriasis

WESTLAKE VILLAGE, Calif., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced plans to advance its program to develop ARQ-151 (topical roflumilast cream) for the treatment of atopic dermatitis into Phase 3 clinical trials following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), without conducting the previously planned Phase 2b atopic dermatitis trial. The Company now anticipates initiating pivotal Phase 3 clinical trials in late 2020 or early 2021. ARQ-151 is a once-daily topical cream formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), which the Company is developing for atopic dermatitis and psoriasis.

“Following our interactions with the FDA, we are delighted to be able to accelerate the development of topical roflumilast cream into Phase 3 trials for the treatment of atopic dermatitis, a disease that affects almost 20 million people in the U.S., of which approximately 60% are children,” said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer. “Results from previous clinical trials have shown that our simple, easy-to-use, once-a-day topical roflumilast cream provided efficacy results similar to those seen with topical JAK inhibitors or mid-potency steroids while also being well tolerated, which is critical in children.  By delivering efficacy that enables meaningful symptomatic improvement and a favorable safety and tolerability profile that supports chronic use for patients with atopic dermatitis, topical roflumilast has the potential to overcome the significant shortcomings of existing therapies, which could mitigate the need for dermatologists and patients to make trade-offs  in efficacy, safety and tolerability.”

Roflumilast  cream is  a once-daily topical  cream  formulation of  a  highly  potent  and  selective  PDE4 inhibitor (roflumilast) that is under development for atopic dermatitis and psoriasis. Oral roflumilast has  been  approved by  the  U.S.  Food  and  Drug  Administration  (FDA) for treatment  to    reduce    the    risk    of    exacerbations  of    chronic    obstructive  pulmonary  disease (COPD) since 2011. Roflumilast has shown greater potency (25-to 300-fold) than the two other FDA-approved PDE4  inhibitors.  PDE4  is  an  intracellular  enzyme  that  increases  the  production    of    pro-inflammatory    mediators    and    decreases    production    of    anti-inflammatory  mediators  and  has  been implicated in a wide range of inflammatory diseases including psoriasis, eczema,  and  COPD.  PDE4  is  an  established  target  in  dermatology,  and  other  PDE4  inhibitors  have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.  Roflumilast cream is already undergoing Phase 3 clinical trials for the treatment of plaque psoriasis, with topline data expected in the first half of 2021.

About Atopic Dermatitis
Atopic dermatitis (AD) is the most common type of eczema, occurring in approximately six percent of the U.S. population.  AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation.  This reaction produces a red, itchy rash, most frequently occurring on the face, arms and legs, and the rash can cover significant areas of the body, in some cases half of the body or more.  Disease onset is most common by 5 years of age, and the Company estimates that approximately 60% of patients suffering from AD are pediatric patients.  The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing.  Given that most of the patients are pediatric, the safety and tolerability of AD therapies are paramount.

About Arcutis - Bioscience, applied to the skin.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis’ robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The company’s lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis.  For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter.

Forward Looking Statements
This press release contains "forward-looking" statements, including, among others, statements regarding the potential of roflumilast cream to address the unmet needs in the topical treatment of atopic dermatitis; the potential safety and efficacy of roflumilast cream;  and the initiation of  pivotal Phase 3 clinical trials in late 2020 or in early 2021. These statements involve 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 and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the "Risk Factors" section of our Form 10-Q filed with U.S. Securities and Exchange Commission (SEC) on August 11, 2020, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Investors and Media:
Heather Rowe Armstrong
Vice President, Investor Relations & Corporate Communications
harmstrong@arcutis.com
805-418-5006, Ext. 740

FAQ

What is the purpose of the Phase 3 clinical trials for ARQT?

The Phase 3 clinical trials aim to evaluate the efficacy and safety of topical roflumilast cream for treating atopic dermatitis.

When is Arcutis planning to start the Phase 3 trials for roflumilast cream?

Arcutis anticipates initiating the pivotal Phase 3 clinical trials in late 2020 or early 2021.

What results were previously reported for roflumilast cream?

Previous trials demonstrated that roflumilast cream provided symptomatic improvement and a favorable tolerability profile.

What is the significance of roflumilast cream for patients with atopic dermatitis?

Roflumilast cream could potentially mitigate the limitations of current therapies, providing a more effective and safer treatment option.

How does roflumilast cream compare to other treatments for atopic dermatitis?

Roflumilast cream has shown efficacy similar to that of topical JAK inhibitors or mid-potency steroids while being well tolerated.