October 2019 - Arcutis Biotherapeutics

Additions enhance corporate expertise across multiple functional areas, including Commercial, Biometrics and Medical Affairs, as Company advances multiple potential best-in-class dermatology development programs, including entering into planned Phase 3 clinical trials in the first half of 2020 for its lead program, ARQ-151

WESTLAKE VILLAGE, CA / ACCESSWIRE / October 30, 2019 / Arcutis Biotherapeutics, Inc. (Arcutis), a privately held clinical-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 addition of three senior biopharmaceutical executives to the Company’s management team:

Kenneth A. Lock, Chief Commercial Officer
Lynn Navale, Vice President, Biometrics
Frank Pompilio, Vice President, Medical Affairs

Frank Watanabe, Arcutis’ President and Chief Executive Officer, commented: “We are absolutely delighted to welcome Ken, Lynn and Frank to the team. Their three roles are critical as we advance our multiple development programs, most significantly, starting our anticipated Phase 3 trials of ARQ-151 in plaque psoriasis in the first half of 2020, and these three accomplished individuals add specialized expertise to our team. Combined with the institutional investor support and funding provided in our recent Series C financing, the addition of these talented leaders strengthens our ability to successfully execute on our founding mission – to develop potential best-in-class product candidates that address unmet medical needs in immuno-dermatology.”

Ken Lock joins the Company as Chief Commercial Officer. He brings over 23 years of global biopharmaceutical commercialization experience, most recently as Executive Director of Sales and Marketing at Gilead Sciences, concurrently leading the Inflammation and Pulmonary Hypertension U.S. commercial franchises. Earlier in his career, Mr. Lock also held key sales and marketing leadership roles at Amgen, Inc., including leading the U.S. marketing of Enbrel to dermatologists.

Lynn Navale joins the Company as Vice President, Biometrics. She brings 20 years of clinical biostatistics, statistical programming and data management expertise, most recently as Vice President of Biometrics at Kite Pharma, where she led the biometrics team responsible for the successful regulatory submissions for Yescarta in both the United States and Europe.

Frank Pompilio, Pharm.D., joins the Company as Vice President, Medical Affairs. He brings over 23 years of experience in medical and scientific affairs, most recently as Vice President, Medical Affairs at Mannkind Corporation. Earlier in his career, Dr. Pompilio led the U.S. medical affairs team for Enbrel at Amgen, Inc.

About Arcutis – Bioscience, applied to the skin.

Arcutis is a clinical-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. Arcutis exploits recent innovations in inflammation and immunology to develop potential best-in-class therapies against validated biological targets, leveraging our deep development, formulation and commercialization expertise to bring to market novel dermatology treatments, while maximizing our probability of technical success and financial resources. Arcutis is currently developing two novel compounds (ARQ-151 and ARQ-252) for multiple indications, including psoriasis, atopic dermatitis and eczema. For more information, please visit www.arcutis.com or follow the Company on LinkedIn.

Contact:

John W. Smither
Chief Financial Officer
jsmither@arcutis.com

Investors and Media:
Derek Cole
720.785.4497
derek.cole@IRadvisory.com

SOURCE: Arcutis Biotherapeutics, Inc.

Related Documents

WESTLAKE VILLAGE, CA / ACCESSWIRE / October 24, 2019 / Arcutis Biotherapeutics, Inc. (Arcutis), a privately held clinical-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 initiate its Phase 3 program of ARQ-151 as a potential topical treatment for plaque psoriasis following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The Company anticipates initiating a Phase 3 clinical trial in the first half of 2020.” data-reactid=”12″ type=”text”>WESTLAKE VILLAGE, CA / ACCESSWIRE / October 24, 2019 / Arcutis Biotherapeutics, Inc. (Arcutis), a privately held clinical-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 initiate its Phase 3 program of ARQ-151 as a potential topical treatment for plaque psoriasis following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The Company anticipates initiating a Phase 3 clinical trial in the first half of 2020.

Frank Watanabe, Arcutis’ President and Chief Executive Officer, commented: "We appreciate the collaborative interaction with the FDA to reach agreement on the key elements of our Phase 3 program that we intend to use to support the submission of a New Drug Application for ARQ-151 for plaque psoriasis. Based on our clinical data to date, we believe ARQ-151 has the potential to be both a best-in-class topical PDE4 inhibitor and the only topical PDE4 inhibitor approved for plaque psoriasis. We look forward to starting our Phase 3 program in the first half of next year."” data-reactid=”13″ type=”text”>Frank Watanabe, Arcutis’ President and Chief Executive Officer, commented: “We appreciate the collaborative interaction with the FDA to reach agreement on the key elements of our Phase 3 program that we intend to use to support the submission of a New Drug Application for ARQ-151 for plaque psoriasis. Based on our clinical data to date, we believe ARQ-151 has the potential to be both a best-in-class topical PDE4 inhibitor and the only topical PDE4 inhibitor approved for plaque psoriasis. We look forward to starting our Phase 3 program in the first half of next year.”

Phase 2 long-term safety study of ARQ-151 in plaque psoriasis. Topline results are expected in the first half of 2021. The Company expects this study to supply the 12-month safety data required for regulatory submissions. In the previous Phase 2b trial in plaque psoriasis, both tested doses of ARQ-151 were well tolerated and demonstrated rapid onset of effect with statistically significant superiority over vehicle. ARQ-151 is a topical cream formulation of roflumilast, a highly potent and selective Phosphodiesterase type 4 (PDE4) inhibitor, which the Company is developing for once-a-day application to treat plaque psoriasis and atopic dermatitis.” data-reactid=”14″ type=”text”>The Company also announced that it has completed enrollment of a 52-week Phase 2 long-term safety study of ARQ-151 in plaque psoriasis. Topline results are expected in the first half of 2021. The Company expects this study to supply the 12-month safety data required for regulatory submissions. In the previous Phase 2b trial in plaque psoriasis, both tested doses of ARQ-151 were well tolerated and demonstrated rapid onset of effect with statistically significant superiority over vehicle. ARQ-151 is a topical cream formulation of roflumilast, a highly potent and selective Phosphodiesterase type 4 (PDE4) inhibitor, which the Company is developing for once-a-day application to treat plaque psoriasis and atopic dermatitis.

Howard Welgus, Arcutis’ Chief Medical Officer, commented: “Because psoriasis is a chronic disease, it is critical to understand the efficacy, safety and tolerability of any new psoriasis treatment over an extended period. Thus, this long-term safety study is important to our understanding of ARQ-151’s potential to address the unmet needs in topical treatment of psoriasis. Furthermore, this strategic clinical development approach to generating long-term safety data allows our Phase 3 studies to be of shorter duration.”

The ARQ-151-202 study is a Phase 2, multi-center, open label study of the long-term safety of ARQ-151 0.3% cream in adult subjects with chronic plaque psoriasis involving up to 25% total body surface area (BSA), evaluated in two cohorts: 231 patients who have completed the ARQ-151-201 Phase 2b, randomized, controlled trial; and 102 previously untreated subjects. The qualifying subjects will apply ARQ-151 0.3% cream once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression. The primary outcome measures of the study are the occurrence of treatment emergent adverse events and the occurrence of serious adverse events.

ARQ-151 is a topical cream formulation containing roflumilast, a PDE4 inhibitor, that Arcutis is developing to treat plaque psoriasis, including intertriginous psoriasis, and atopic dermatitis. PDE4 is an intracellular enzyme that regulates the production of pro-inflammatory and anti-inflammatory cytokines and cell proliferation. Roflumilast is a potent PDE4 inhibitor that was approved by the FDA for systemic treatment to reduce risk of exacerbation of chronic obstructive pulmonary disease (COPD) in 2011, and has shown greater potency based on IC50 values (a non-clinical measure of a drug’s potency) than other PDE4 inhibitors.

Psoriasis is a common, non-contagious, immune disease that affects approximately 8.6 million patients in the United States. About 90% of psoriasis cases are plaque psoriasis, which is characterized by “plaques”, or raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and the plaques are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

www.arcutis.com or follow the Company on LinkedIn.” data-reactid=”26″ type=”text”>Arcutis is a clinical-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. Arcutis exploits recent innovations in inflammation and immunology to develop potential best-in-class therapies against validated biological targets, leveraging our deep development, formulation and commercialization expertise to bring to market novel dermatology treatments, while maximizing our probability of technical success and financial resources. Arcutis is currently developing two novel compounds (ARQ-151 and ARQ-252) for multiple indications including psoriasis, atopic dermatitis and eczema. For more information, please visit www.arcutis.com or follow the Company on LinkedIn.

jsmither@arcutis.com” data-reactid=”28″ type=”text”>John W. Smither
Chief Financial Officer
jsmither@arcutis.com

Investors and Media:

derek.cole@IRadvisory.com

HBM Healthcare Investments, Vivo Capital, BlackRock, Omega Funds, Pivotal BioVentures, and Goldman Sachs join existing investors Frazier Healthcare Partners, Bain Capital Life Sciences, OrbiMed and RA Capital Management

Funds Phase 3 clinical development of lead product candidate ARQ-151 topical cream in plaque psoriasis

Also funds continued development of ARQ-151 in atopic dermatitis

WESTLAKE VILLAGE, CA / ACCESSWIRE / October 21, 2019 / Arcutis Biotherapeutics, Inc. (“Arcutis”), a privately held clinical-stage biopharmaceutical company focusing on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced that it has completed a $94.5 million Series C financing led by HBM Healthcare Investments. Additional new investors included Vivo Capital, funds and accounts managed by BlackRock, Omega Funds, Pivotal BioVentures, and Goldman Sachs. New investors accounted for more than 50% of the total Series C investment. In addition, existing investors, including Frazier Healthcare Partners, Bain Capital Life Sciences, OrbiMed, and RA Capital Management, provided continued strong support and accounted for the remainder of the Series C proceeds. Since its founding in 2016, Arcutis has raised more than $160 million.

In connection with the financing, Dr. Alexander Asam, Investment Advisor of HBM Partners, has joined Arcutis’ Board of Directors. Dr. Asam brings more than 20 years of experience as a global life sciences investor.

Arcutis plans to use the proceeds of the financing to fund Phase 3 clinical development of its lead product candidate ARQ-151, a topical cream formulation containing roflumilast, in plaque psoriasis. In addition, it plans to fund continued development of ARQ-151 in atopic dermatitis. Arcutis currently anticipates reporting topline data for Phase 3 studies in plaque psoriasis in the first half of 2021. Phase 2a topline data in atopic dermatitis is expected by year end 2019.

Frank Watanabe, Arcutis’ President and Chief Executive Officer, commented: “We are delighted to expand our network of impactful and experienced life science investors, including adding Dr. Asam to our Board of Directors, and appreciate the continued strong support of our existing investors. We are excited about the shared commitment to developing dermatology products with the potential to positively impact patients’ lives across multiple skin diseases.”

About Arcutis – Bioscience, applied to the skin.

Contact:

John W. Smither
Chief Financial Officer
jsmither@arcutis.com

Investors and Media:
Derek Cole
720.785.4497
derek.cole@IRadvisory.com

###

SOURCE: Arcutis Biotherapeutics, Inc

Phase 2a topline data anticipated by year end 2019
ARQ-151 potential “Best in Class” topical PDE4 inhibitor
Demonstrated potency advantage of 25x to greater than 300x compared to two FDA approved PDE4 inhibitors

WESTLAKE VILLAGE, CA / ACCESSWIRE / October 9, 2019 / Arcutis Biotherapeutics, Inc. (Arcutis), a privately held clinical-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced that it has completed enrollment of a Phase 2a clinical trial evaluating ARQ-151 as a potential treatment for atopic dermatitis (AD). ARQ-151, Arcutis’ lead product candidate, is a once daily topical cream formulation of roflumilast, a highly potent and selective Phosphodiesterase type 4 inhibitor (PDE4), which we are developing for plaque psoriasis and atopic dermatitis.

Howard Welgus, M.D., Arcutis’ Chief Medical Officer, commented: “We are delighted with the rapid pace of enrollment in this study, which started in June of this year. We believe ARQ-151 has significant potential as an atopic dermatitis treatment given that PDE4 inhibition is a well-established mechanism to treat AD, coupled with ARQ-151’s potency advantage of 25x to in excess of 300x compared to the potency of the two FDA-approved PDE4 inhibitors and the excellent tolerability ARQ-151 previously demonstrated in our trials in psoriasis as well as in our Phase 1 study in AD. Based on the clinical data generated to date, we believe ARQ-151 has the potential to address the substantial need that we believe exists for an atopic dermatitis topical therapy that offers efficacy in-line with high-potency steroids, a favorable tolerability profile, the ability to treat chronically, and that has little to none of the application site reactions associated with many existing treatments. We anticipate having topline data from this study by the end of this year.”

The ARQ-151-212 study is a multi-center, multi-national, double blind, vehicle-controlled Phase 2a study, in which 136 adolescents (ages 12 and above) and adults with atopic dermatitis covering between 1.5% and 35% body surface area (BSA) were randomized to receive once a day topical applications for 4 weeks of: (1) ARQ-151 cream 0.15%, or (2) ARQ-151 cream 0.05%, or (3) vehicle. The study will assess the safety, pharmacokinetics (PK) and efficacy of the two dose levels of ARQ-151. The primary efficacy endpoint is change from baseline in Eczema Area and Severity Index (EASI) Total Score at week 4. Multiple secondary outcome measures will also be assessed, including, among others, percent change from baseline in EASI Total Score, achievement of a 50% or greater improvement in EASI (EASI50) score from baseline, and Worst Itch-Numerical Rating Scale (WI-NRS) pruritus score.

About ARQ-151

ARQ-151 is a topical cream formulation containing roflumilast, a PDE4 inhibitor, that we are developing to treat plaque psoriasis, including intertriginous psoriasis, and atopic dermatitis. PDE4 is an intracellular enzyme that regulates the production of pro-inflammatory and anti-inflammatory cytokines and cell proliferation. Roflumilast is a potent PDE4 inhibitor that was approved by the U.S. Food and Drug Administration (FDA) for systemic treatment to reduce risk of exacerbation of chronic obstructive pulmonary disease (COPD) in 2011, and has shown greater potency based on IC50 values (a non-clinical measure of a drug’s potency) than other PDE4 inhibitors.

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 we estimate 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 is paramount.

About Arcutis – Bioscience, applied to the skin.

Arcutis is a clinical-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. Arcutis exploits recent innovations in inflammation and immunology to develop potential best-in-class therapies against validated biological targets, leveraging our deep development, formulation and commercialization expertise to bring to market novel dermatology treatments, while maximizing our probability of technical success and financial resources. Arcutis is currently developing two novel compounds (ARQ-151 and ARQ-252) for multiple indications including psoriasis, atopic dermatitis and eczema. For more information, please visit www.arcutis.com or follow Arcutis on LinkedIn.

Contact:

John W. Smither
Chief Financial Officer
jsmither@arcutis.com

Investors and Media:
Derek Cole
720.785.4497
derek.cole@IRadvisory.com

###

SOURCE: Arcutis Biotherapeutics, Inc.

Meaningful innovation at a glance.

Download our corporate fact sheet.

Download