ARQT Arcutis Biotherapeutics Inc.

20.13
-1.12  -5%
Previous Close 21.25
Open 20.89
52 Week Low 17.1
52 Week High 40.88
Market Cap $877,452,347
Shares 43,589,287
Float 23,406,239
Enterprise Value $705,987,348
Volume 293,419
Av. Daily Volume 237,878
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Upcoming Catalysts

Drug Stage Catalyst Date
ARQ-154
Scalp psoriasis
Phase 2b
Phase 2b
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ARQ-151
Plaque psoriasis
Phase 3
Phase 3
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ARQ-151
Plaque psoriasis
Phase 2
Phase 2
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ARQ-252
Chronic Hand Eczema
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
ARQ-154
Seborrheic dermatitis
Phase 2
Phase 2
Phase 2 primary endpoint met - September 29, 2020.
ARQ-151
Atopic dermatitis
Phase 3
Phase 3
Phase 3 trial to be initiated late-2020 or early-2021.
ARQ-252
Vitiligo
Phase 2a
Phase 2a
Phase 2 trial to be initiated in 2H 2020.

Latest News

    • ARQ-252 is a potent and highly selective topical JAK1 inhibitor offering potential safety advantages over less selective JAK inhibitors
    • Hand eczema is the most common skin disease affecting the hands, impacting more than 8 million Americans
    • Topline data now anticipated by mid-2021

    WESTLAKE VILLAGE, Calif., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that it completed enrollment in its Phase 1/2b study of ARQ-252, a potent and highly selective topical small molecule inhibitor of Janus kinase type 1 (JAK1), in adult patients with chronic hand eczema. Arcutis has…

    • ARQ-252 is a potent and highly selective topical JAK1 inhibitor offering potential safety advantages over less selective JAK inhibitors

    • Hand eczema is the most common skin disease affecting the hands, impacting more than 8 million Americans
    • Topline data now anticipated by mid-2021

    WESTLAKE VILLAGE, Calif., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that it completed enrollment in its Phase 1/2b study of ARQ-252, a potent and highly selective topical small molecule inhibitor of Janus kinase type 1 (JAK1), in adult patients with chronic hand eczema. Arcutis has updated its projections and now anticipates announcing topline data from this trial by mid-2021.

    "We were pleased with the speed with which this trial enrolled, underscoring the high unmet need for new treatments to treat this chronic skin disease that can cause significant skin irritation and discomfort and can have a negative impact on a patient's quality of life," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "More than eight million people in the U.S. suffer from hand eczema, and patients often have to make trade-offs between drug efficacy, safety, and tolerability with current available treatments. ARQ-252 has demonstrated robust potency and high selectivity for JAK1 over JAK2, thereby giving it the potential to deliver efficacy without causing the side effects typical of other less selective JAK inhibitors. Given this, we believe ARQ-252 has the potential to reduce the need to compromise between safety and efficacy."

    In April, Arcutis began the Phase 1 portion of this Phase 1/2b study to assess the safety, tolerability, and pharmacokinetics of once daily application of ARQ-252 cream 0.3% to both hands for two weeks in seven subjects with chronic hand eczema. In July, the Company began the Phase 2b portion of the study to assess the safety and efficacy of ARQ-252 cream 0.1% once daily and ARQ-252 cream 0.3% once daily or twice daily versus vehicle applied once daily or twice daily for 12 weeks to patients with chronic hand eczema. Enrollment of the Phase 2b portion is now complete with 223 subjects. The Company expects to report topline data by mid-2021.

    About Hand Eczema

    Hand eczema is a common inflammatory skin disease with prevalence estimated at up to 2.5% of the population, and is the most common skin disease affecting the hands. Symptoms of hand eczema can vary and include redness, fluid filled blisters or bumps, scaling, cracking, itching and pain occurring on the hands. It may occur in various forms, incorporating dyshidrotic eczema, an immune disease possibly related to atopic dermatitis; irritant contact dermatitis of the hands, which may be caused by occupational irritants; allergic contact dermatitis of the hands, which is caused by an allergic reaction; atopic hand dermatitis, which is atopic dermatitis occurring on the hands, and hyperkeratotic hand dermatitis, which are thickened, scaly, red plaques, similar to psoriasis, on the hands. The impact of hand eczema on patients can be significant, leading to work absences or disability, social stigmatization, and psychosocial distress.

    About ARQ-252

    ARQ-252 is a potent and highly selective topical, small molecule inhibitor of Janus kinase type 1 (JAK1). Many inflammatory cytokines and other signaling molecules rely on the JAK pathway, and specifically JAK1, which plays a central role in immune system function. Inhibition of JAK1 has been shown to treat a range of inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and atopic dermatitis. The Company believes that due to its high selectivity for JAK1 over JAK2, ARQ-252 has the potential to effectively treat inflammatory diseases without causing the hematopoietic adverse effects typically associated with JAK2 inhibition. In 2018, Arcutis exclusively licensed the active pharmaceutical ingredient in ARQ-252 for all topical dermatological uses in the United States, Europe, Japan and Canada from Jiangsu Hengrui Medicine Co., Ltd. of China. In mid-2019, Hengrui completed a Phase 2b study in rheumatoid arthritis that used the same active pharmaceutical ingredient as in ARQ-252 but dosed orally. The results confirmed that this active pharmaceutical ingredient is a highly potent inhibitor of JAK1 based on the drug's impact on rheumatoid arthritis, and was generally well tolerated at exposures well above those expected with topical administration of ARQ-252 in patients with chronic hand eczema. Reistone Biopharma, a subsidiary of Hengrui, is also studying the oral formulation as a potential treatment for alopecia areata, Crohn's disease, ulcerative colitis and atopic dermatitis.

    About Arcutis - Bioscience, applied to the skin.

    Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions. 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 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 for ARQ-252 to treat hand eczema without causing the adverse effects associated with other JAK inhibitors; and the anticipated timing of the topline data of the Phase 2b portion of the study. 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



    805-418-5006, Ext. 740

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  1. WESTLAKE VILLAGE, Calif., Oct. 06, 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 the closing of its underwritten public offering of 4,000,000 shares of its common stock at a public offering price of $25.00 per share, before underwriting discounts and commissions. All of the shares in the public offering were sold by Arcutis. The gross proceeds from the public offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Arcutis, were $100.0 million. In addition…

    WESTLAKE VILLAGE, Calif., Oct. 06, 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 the closing of its underwritten public offering of 4,000,000 shares of its common stock at a public offering price of $25.00 per share, before underwriting discounts and commissions. All of the shares in the public offering were sold by Arcutis. The gross proceeds from the public offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Arcutis, were $100.0 million. In addition, Arcutis has granted the underwriters a 30-day option to purchase up to an additional 600,000 shares of Arcutis' common stock at the public offering price less the underwriting discounts and commissions.

    Concurrent with the completion of the public offering, Arcutis sold to OrbiMed Advisors, LLC, an affiliate of one of the Company's directors, 1,400,000 shares of its common stock in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, at a price per share equal to the public offering price. The gross proceeds from the private placement were $35.0 million.

    Goldman Sachs & Co. LLC, Cowen and Company, LLC, and Guggenheim Securities, LLC are acting as bookrunning managers for the public offering. Truist Securities, Inc. and Cantor Fitzgerald & Co. are acting as lead managers for the public offering.

    A registration statement on Form S-1 relating to the securities being sold in the public offering has been filed with the Securities and Exchange Commission (the "SEC") and became effective on October 1, 2020. The public offering was made only by means of a prospectus. Copies of the prospectus relating to the offering may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at ; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, by telephone at (833) 297-2926, or by email at ; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658, or by email at . You may also obtain these documents free of charge by visiting the SEC's website at www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications



    805-418-5006, Ext. 740

    Primary Logo

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  2. WESTLAKE VILLAGE, Calif., Oct. 01, 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 the pricing of its underwritten public offering of 4,000,000 shares of its common stock at a public offering price of $25.00 per share, before underwriting discounts and commissions. All of the shares in the offering are to be sold by Arcutis. In addition, Arcutis has granted the underwriters a 30-day option to purchase up to 600,000 additional shares of its common stock. The gross proceeds from the public offering, before deducting underwriting…

    WESTLAKE VILLAGE, Calif., Oct. 01, 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 the pricing of its underwritten public offering of 4,000,000 shares of its common stock at a public offering price of $25.00 per share, before underwriting discounts and commissions. All of the shares in the offering are to be sold by Arcutis. In addition, Arcutis has granted the underwriters a 30-day option to purchase up to 600,000 additional shares of its common stock. The gross proceeds from the public offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Arcutis, are expected to be $100.0 million, excluding any exercise of the underwriters' option to purchase additional shares. The offering is expected to close on Oct. 6, 2020, subject to customary closing conditions.

    Concurrent with the completion of the public offering, Arcutis expects to sell to entities affiliated with OrbiMed Advisors, LLC, an affiliate of one of the Company's directors, 1,400,000 shares of its common stock in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, at a price per share equal to the public offering price. The gross proceeds from the private placement are expected to be $35.0 million. The private placement will be contingent on the closing of the underwritten public offering and the satisfaction of customary closing conditions. The underwritten public offering is not contingent on the private placement.

    Goldman Sachs & Co. LLC, Cowen and Company, LLC, and Guggenheim Securities, LLC are acting as bookrunning managers for the public offering. Truist Securities, Inc. and Cantor Fitzgerald & Co. are acting as lead managers for the public offering.

    A registration statement on Form S-1 relating to the securities being sold in the public offering has been filed with the Securities and Exchange Commission (the "SEC") and became effective on October 1, 2020. The public offering is being made only by means of a prospectus. Copies of the prospectus relating to the offering may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at ; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, by telephone at (833) 297-2926, or by email at ; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658, or by email at . You may also obtain these documents free of charge by visiting the SEC's website at www.sec.gov.

    The securities in the public offering may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications



    805-418-5006, Ext. 740

    Primary Logo

    View Full Article Hide Full Article
  3. WESTLAKE VILLAGE, Calif., Sept. 29, 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 the commencement of an underwritten public offering of 4,000,000 shares of its common stock. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to 600,000 additional shares of its common stock.

    Concurrent with the completion of the public offering, Arcutis expects to sell to OrbiMed Advisors, LLC, an affiliate of one of the Company's directors, $35.0 million of shares of its common stock in a private…

    WESTLAKE VILLAGE, Calif., Sept. 29, 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 the commencement of an underwritten public offering of 4,000,000 shares of its common stock. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to 600,000 additional shares of its common stock.

    Concurrent with the completion of the public offering, Arcutis expects to sell to OrbiMed Advisors, LLC, an affiliate of one of the Company's directors, $35.0 million of shares of its common stock in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, at a price per share equal to the public offering price. The private placement will be contingent on the closing of the underwritten public offering and the satisfaction of customary closing conditions. The underwritten public offering is not contingent on the private placement.

    Goldman Sachs & Co. LLC, Cowen and Company, LLC, and Guggenheim Securities, LLC are acting as bookrunning managers for the offering. Truist Securities, Inc. and Cantor Fitzgerald & Co. are acting as lead managers for the offering.

    A registration statement on Form S-1 relating to the securities being sold in this offering has been filed with the Securities and Exchange Commission (the "SEC") but has not yet been declared effective.   The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the proposed offering may be obtained, when available, from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at ; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, by telephone at (833) 297-2926, or by email at ; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658, or by email at . You may also obtain these documents free of charge by visiting the SEC's website at www.sec.gov.

    These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    Forward Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the timing, size and completion of the proposed public offering and concurrent private placement. 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 preliminary prospectus filed with the U.S. Securities and Exchange Commission (SEC) on September 29, 2020 and our other reports and filings filed 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.

    Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications



    805-418-5006, Ext. 740

     

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    • Roflumilast foam demonstrated statistically significant improvement over the vehicle foam on the trial's primary and multiple secondary endpoints

    • Once-daily roflumilast foam demonstrated a favorable safety and tolerability profile
    • Roflumilast foam potential "Best in Class" topical PDE4 inhibitor
    • Seborrheic dermatitis affects 10 million U.S. patients
    • Company to host a conference call today at 8:30 a.m. EST

    WESTLAKE VILLAGE, Calif., Sept. 29, 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 positive topline data from its Phase

    • Roflumilast foam demonstrated statistically significant improvement over the vehicle foam on the trial's primary and multiple secondary endpoints



    • Once-daily roflumilast foam demonstrated a favorable safety and tolerability profile
    • Roflumilast foam potential "Best in Class" topical PDE4 inhibitor
    • Seborrheic dermatitis affects 10 million U.S. patients
    • Company to host a conference call today at 8:30 a.m. EST

    WESTLAKE VILLAGE, Calif., Sept. 29, 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 positive topline data from its Phase 2 clinical trial evaluating ARQ-154 (topical roflumilast foam) as a potential treatment for seborrheic dermatitis.

    Roflumilast foam 0.3% administered once daily for 8 weeks demonstrated statistically significant improvement compared to a matching vehicle foam on key efficacy endpoints in subjects with moderate-to-severe seborrheic dermatitis. On the study's primary endpoint assessed at week 8, roflumilast foam 0.3% achieved an Investigator Global Assessment (IGA) success rate of 73.8% compared to a vehicle rate of 40.9% (p<0.0001). IGA success is defined as the achievement of an IGA score of 'clear' or 'almost clear' on a 5-grade scale PLUS at least a two-point change from baseline. The onset of effect was rapid, with ARQ-154 statistically separating from vehicle as early as week 2, the first visit after baseline, on IGA success as well as multiple secondary endpoints. For example, at week 8, 64.6% of subjects treated with roflumilast foam who had a baseline Worst Itch Numeric Rating Scale (WI-NRS) score of 4 achieved an itch reduction of at least 4 points compared to 34.0% of vehicle treated subjects (p=0.0007). Other secondary endpoints included overall assessment of erythema and overall assessment of scaling, which also had positive outcomes. Importantly, roflumilast foam was well-tolerated, with rates of application site adverse events, treatment-related adverse events, and discontinuations due to adverse events low and similar to vehicle. Only 2 out of 154 subjects (1.3%) treated with roflumilast foam discontinued the study due to an adverse event, compared to 1 out of 72 subjects (1.4%) treated with the vehicle.

    "Seborrheic dermatitis is one of the most common skin conditions dermatologists deal with in adults, right up there with acne, rosacea, psoriasis and eczema. It has an enormous effect on patient's lives because it is so visible and often embarassing, with red, greasy, flaky areas on the face and scalp that are almost impossible to hide. Making it even worse, many of the more than 10 million sufferers in the U.S. may not know what it is, thereby contributing to the problem of under-treatment and inadequate treatment of the disease," said Matthew Zirwas, M.D., founder of the Bexley Dermatology Research Clinic and an investigator in the trial. "Current topical treatments for seborrheic dermatitis have major limitations, either having low efficacy, such as with topical antifungals, topical immunomodulators, low potency steroids and prescription shampoos, or high efficacy but unacceptable side effect profiles, such as with high potency topical steroids. Of the major dermatologic diseases, it has the greatest need for new treatment options. I believe these data demonstrate that once daily roflumilast foam is well-tolerated and effective. In my opinion, if approved, it has the potential to become the new standard of care in seborrheic dermatitis."

    "We are delighted with the robust signal for the efficacy of roflumilast foam in this relatively small, study. In this trial, topical roflumilast foam demonstrated meaningful symptomatic improvement, including a reduction in itch, alongside a favorable safety and tolerability profile that supports chronic use," said Patrick Burnett, M.D., Ph.D., FAAD, and Chief Medical Officer of Arcutis. "With once-a-day dosing, roflumilast foam potentially offers the convenience of a single, easy to use product to treat seborrheic dermatitis in all body locations where a patient might be affected. Unlike creams and ointments, roflumilast foam is suitable for use in hair-bearing areas; unlike steroids, it is expected to be suitable for long-term use on the face; and unlike shampoos, it is an elegant, quick drying, leave-in foam that doesn't need to be rinsed out. If successful in Phase 3 clinical trials and approved for commercialization, roflumilast foam will be the first topical drug treatment in decades to offer a novel mechanism of action for the treatment of seborrheic dermatitis, and has the potential to positively affect the symptoms and quality of life of patients who suffer from this distressing chronic skin condition."

    Between December 2019 and June 2020, the Phase 2 trial enrolled 226 adult subjects with moderate-to-severe seborrheic dermatitis. This 8-week, multi-center, multi-national, double blind, vehicle-controlled study evaluated the safety and efficacy of roflumilast foam 0.3% administered once-daily to affected areas on the scalp, face, and body. Topline efficacy data, including the primary endpoint, IGA success at week 8, were analyzed using the population of all randomized subjects with the exception of subjects who missed the week 8 IGA assessment specifically due to COVID-19 disruption. Importantly, only two subjects missed the week 8 IGA assessment due to concerns arising from COVID-19, and therefore the Intent-to-Treat (ITT) and modified ITT populations differed by only two subjects. Arcutis expects to present the full results from the trial at a future medical conference.

    Management will host a conference call today at 8:30 a.m. EST to discuss these results. To access the call, please dial (833) 614-1393 (domestic) or (914) 987-7114 (international) prior to the scheduled conference call time and provide the conference ID 7378204. A live webcast of the call will be available on the "Investors" section of the company's website, www.arcutis.com. An archived version of the webcast will be available on the Arcutis website after the call.

    Roflumilast foam is a once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4 inhibitor) that Arcutis is developing particularly to treat inflammatory dermatoses in hair-bearing areas of the body such as the scalp.

    Roflumilast has been approved by the FDA for systemic 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.

    Arcutis believes roflumilast foam has significant potential as a treatment for seborrheic dermatitis. Roflumilast foam is nearly identical to ARQ-151 (topical roflumilast cream), Arcutis' investigational topical cream PDE4 inhibitor that has demonstrated symptomatic improvement and a favorable tolerability profile in Arcutis' clinical trials in plaque psoriasis, as well as encouraging results in atopic dermatitis. Arcutis completed enrollment in DERMIS-1 and DERMIS-2, the Company's pivotal Phase 3 clinical trials evaluating topical roflumilast cream as a potential topical treatment for plaque psoriasis, and the Company expects to announce topline data in the first quarter of 2021 and to submit a New Drug Application (NDA) submission by the end of 2021. In addition, following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), Arcutis plans to advance its program to develop topical roflumilast cream for the treatment of atopic dermatitis into Phase 3 clinical trials beginning in late 2020 or early 2021.

    In addition to this Phase 2 trial, Arcutis is also conducting a Phase 2 long-term safety study

    in seborrheic dermatitis. This is a multicenter, open-label study of roflumilast foam 0.3% applied once daily in patients with seborrheic dermatitis and will include patients who were treated previously in the Phase 2 trial, as well as patients naïve to treatment with topical roflumilast foam. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement, or progression.

    About Seborrheic Dermatitis

    Seborrheic dermatitis affects more than 10 million people in the U.S., and is a common, chronic or recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. Seborrheic dermatitis occurs most often on the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest and back.

    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 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 ARQ-154's potential as a seborrheic dermatitis treatment; the Company's expectation to present the full results from the seborrheic dermatitis trial at a future medical conference; the Company's plan to announce ARQ-151 topline data for plaque psoriasis in the first quarter of 2021 and to submit a New Drug Application (NDA) submission by the end of 2021; the Company's plan to initiate pivotal Phase 3 clinical trials for ARQ-151 in atopic dermatitis in late 2020 or 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.

    Investor Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications



    805-418-5006, Ext. 740

    Media Contact:

    Mike Beyer

    Sam Brown Inc. Healthcare Communications



    312-961-2502 

    A PDF accompanying this announcement is available at http://ml.globenewswire.com/Resource/Download/630458c3-2f79-40cc-8260-2ef350559bbd

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