아커티스 바이오테라퓨틱스 주가가 피부염 치료용 Arcutis의 ZORYVE®(roflumilast) 국소 폼, 0.3% 승인 소식에 데이 마켓에서 강한 변동성을 보이고 있습니다.
아커티스 바이오테라퓨틱스는 어떤 기업이고, 아커티스의 ZORYVE®(roflumilast) 국소 폼, 0.3% 승인 소식과 주가 전망까지 체크해 보도록 하겠습니다.
목차
아커티스 바이오테라퓨틱스(ARQT)는 어떤 기업?
아커티스 바이오테라퓨틱스는 50개 이상의 FDA 승인 제품을 보유하고 있는 업계 리더, 7명의 피부과 의사, 피부과 최고의 국소 약물 제조자가 존재하는 미국 바이오 기업입니다.
피부 질병에 특화된 기업으로 미충족 의료 수요가 높은 피부과 질환 치료제 개발 및 상용화에 주력하고 있습니다.
특히 아커티스 바이오테라퓨틱스의 주력 제품인 조리브(ZORYVE)는 12세 이상의 개인을 대상으로 간질 부위의 건선을 포함한 플라크 건선을 치료하기 위한 제품입니다.
조리브(ZORYVE)는 매우 강력하고 선택적인 포스포다이에스테라제-4(PDE4) 억제제인 로플루밀라스트의 1일 1회 국소 제형으로 만성적인 사용을 위해 1일 1회 간단한 도포가 가능하도록 설계되었으며, 도포 시 화상이나 따끔거림이 발생하지 않으며, 얼굴이나 간질 부위와 같이 민감하거나 치료가 어려운 부위를 포함하여 신체의 어느 부위에도 사용이 가능하다는 장점이 있습니다.
아커티스 바이오테라퓨틱스 파이프라인
아커티스 바이오테라퓨틱스 파이프라인은 Topical Roflumilast Cream(ARQ-151)은 현재 FDA 승인되었고, Topical Roflumilast Foam(ARQ-154) 역시 FDA 승인 되었습니다.
아커티스 바이오테라퓨틱스 ZORYVE®(roflumilast) 국소 폼, 0.3% FDA 승인
미국 식품의약국(FDA)이 9세 이상 지루성 피부염 치료를 위한 0.3% ZORYVE(roflumilast) 국소 폼에 대한 신약 신청(NDA)을 승인 했다는 소식이 있습니다.
아커티스 바이오테라퓨틱스 관련된 기사 원문은 아래에서 확인 가능합니다.(기사 원문 출처 : https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-topical-foam-0-3-for-the-treatment-of-seborrheic-dermatitis-in-individuals-aged-9-years-and-older/)
- ZORYVE foam represents a highly effective, safe, well-tolerated, once-daily steroid-free foam for use on all affected areas of the body, including hair-bearing areas, with no limitations on duration of use
- ZORYVE foam provides rapid disease clearance and significant reduction in itch, one of the most burdensome symptoms of seborrheic dermatitis
- First drug approved for seborrheic dermatitis with a new mechanism of action in over two decades
- Seborrheic dermatitis affects more than 10 million people in the United States
- Commercial product expected to be available by end of January
- Management will host conference call on Monday, December 18 at 8:30 a.m. EST
WESTLAKE VILLAGE, Calif., Dec. 15, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has approved the new drug application (NDA) for ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older. ZORYVE foam provides rapid disease clearance and significant reduction in itch, with nearly 80% of individuals achieving the primary efficacy endpoint of IGA Success and just over 50% of individuals reaching complete clearance at Week 8 in the STRATUM trial. ZORYVE is a once-daily steroid-free foam and the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades.
“We know from dermatology clinicians and those living with seborrheic dermatitis that there has been a real struggle with disease clearance and treatment adherence due to lack of efficacy, difficulty treating certain body areas, inconvenient treatment regimens, and concerns about safety with long-term use,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “ZORYVE foam is a once-daily, steroid-free topical treatment that can be used anywhere on the body, including hair-bearing areas, with no limitation on duration of use. We are proud to deliver meaningful innovation through this approval of ZORYVE foam, and to offer a new topical treatment that effectively clears and controls the disease and can simplify its management for the millions of adults and adolescents living with seborrheic dermatitis.”
Seborrheic dermatitis affects more than 10 million people in the United States, and is a common, chronic, and recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. In individuals with darker skin tones, inflamed areas may not appear red, but instead can appear pink, slightly purple, or lighter in color than the surrounding skin. It occurs most often in areas of the body with oil-producing (sebaceous) glands, including the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back. Hair-bearing areas make applying topicals like creams, gels, and ointments difficult.
“In the STRATUM trial, ZORYVE foam provided rapid disease clearance as early as Week 2 and significant itch relief in as little as 48 hours. In addition, almost 80% of patients achieved treatment success at Week 8. While multiple factors contribute to seborrheic dermatitis, inflammation and skin barrier dysfunction play key roles. ZORYVE has been shown to effectively reduce the signs of inflammation, redness, and scaling in patients with seborrheic dermatitis, and with its unique formulation, ZORYVE foam effectively delivers the drug without disrupting the skin barrier and has been shown to be safe and tolerable. ZORYVE foam is thus ideally formulated, having the potential to become the new standard of care for seborrheic dermatitis treatment,” said Andrew Blauvelt, MD, MBA, clinical investigator at Oregon Medical Research Center, and investigator on the STRATUM trial.
Beyond the appearance and irritation of physical symptoms, seborrheic dermatitis is associated with a decrease in quality of life and may negatively affect emotional well-being, self-esteem, and day-to-day life, including sleep and work. People with seborrheic dermatitis, and especially adolescents and school-age children, may suffer from social stigma, negative self-image, and low self-esteem associated with very visible skin diseases like seborrheic dermatitis.
“Approximately 10 million people in the United States have seborrheic dermatitis, but until today, there have been limited treatment options. We are thrilled with this FDA approval and are excited to bring to market a new, highly effective steroid-free topical formulation that can be used anywhere on the body,” said Frank Watanabe, president and CEO of Arcutis. “Our commercial team is ready and poised to launch ZORYVE foam very soon, and we are committed to ensuring affordable access to ZORYVE foam to those who may benefit from this novel treatment.”
Arcutis intends to make ZORYVE foam widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of January 2024. The Company is dedicated to responsible pricing and affordable access to therapy. The ZORYVE® Direct Program helps patients access their prescribed Arcutis medication. For patients with seborrheic dermatitis who have been prescribed ZORYVE, this patient support program helps patients navigate the payer process, assists patients with adherence, and includes the ZORYVE Direct Savings Card Program, which can help reduce out-of-pocket costs for eligible commercially insured patients.† Arcutis will also continue to offer the Arcutis CaresTM patient assistance program (PAP) that provides ZORYVE at no cost for financially eligible patients who are uninsured or underinsured.‡
Management will host a conference call on Monday, December 18 at 8:30 a.m. EST. A live webcast of the call and presentation material will be available on the “Events” section of the Company’s Investor website. An archived version of the webcast will be available on the Arcutis website after the call.
ZORYVE Foam Clinical Data
The approval is supported by positive results from Arcutis’ Phase 2 and pivotal Phase 3 trials in seborrheic dermatitis. The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) and the Phase 2 (Trial 203) were parallel group, double-blind, vehicle-controlled studies evaluating the safety and efficacy of ZORYVE foam 0.3% in seborrheic dermatitis. Together the two studies enrolled 683 adults and adolescents ages 9 years and older.
The STRATUM study met its primary endpoint, with nearly 80% of ZORYVE foam treated individuals reaching Investigator Global Assessment (IGA) Success rate at Week 8 (79.5% ZORYVE foam vs 58.0% vehicle; P<0.0001). In Trial 203, 73% of individuals treated with ZORYVE foam achieved IGA Success (73.1% ZORYVE foam vs 40.8% vehicle; P<0.0001.) IGA Success was defined as an IGA score of “Clear” (0) or “Almost Clear” (1), plus a 2-grade IGA score improvement from baseline at Week 8.
Improvement with ZORYVE foam was seen early, with roflumilast demonstrating a statistically significant improvement compared to vehicle on IGA Success at Week 2, the first timepoint assessed in STRATUM. In addition, 50.6% of individuals in the ZORYVE foam treated arm reached complete clearance (IGA=0) at Week 8.
The STRATUM study also demonstrated statistically significant improvement over vehicle on all secondary endpoints, including itch, scaling, and erythema (redness). More than 60% of individuals achieved a ≥4-point reduction in itch at Week 8 as measured by Worst Itch-Numerical Rating Score (62.8% roflumilast foam vs 40.6% vehicle; P=0.0001), and significant improvements in itch were also reported at Week 2 and Week 4. Individuals treated with ZORYVE foam reported a 28% improvement in itch from baseline in 48 hours (compared to 13% on vehicle nominal P=0.0024).
In addition, more than 50% of individuals treated with ZORYVE foam achieved an erythema (redness) score of 0, and more than 50% achieved a scaling score of 0, at Week 8. Treatment with ZORYVE foam demonstrated a significantly larger improvement in patient reported outcomes as early as Week 2 as measured through Dermatology Life Quality Index (DLQI), with improvements maintained through Week 8.
ZORYVE foam was well-tolerated with a favorable safety and tolerability profile during up to 52 weeks of treatment. Incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. There were no treatment-related Serious Adverse Events (SAEs). Overall, the most common adverse reactions occurring in ≥1% of subjects in the combined Phase 2 and Phase 3 study populations were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
위의 아커티스 바이오테라퓨틱스 기사를 조금 해석해보면 ZORYVE 폼은 빠른 질병 제거와 상당한 가려움증 감소를 제공하며, 거의 80%의 개인이 IGA 성공의 1차 유효성 평가변수를 달성하고 50%가 넘는 개인이 STRATUM 시험 8주차에 완전한 제거에 도달 했다는 내용이 있습니다.
아커티스 바이오테라퓨틱스의 조리브(ZORYVE)는 1일 1회 복용하는 스테로이드가 없는 폼으로 지난 20여년 만에 지루성 피부염에 대해 새로운 작용 기전으로 승인된 최초의 약물로 이를 통해 미국 FDA의 승인을 받아냈다는 것이 골자입니다.
아커티스 바이오테라퓨틱스 주가 전망
아커티스 바이오테라퓨틱스 주가 일봉차트를 체크해보면 이동평균선 역배열 하락 흐름을 타면서 주가가 내려오다가 지난 12월 초부터 반등에 성공해 주가가 서서히 반등하고 있었습니다.
3.06달러 부근까지 단기 매물대 저항이 강해 거래량이 소폭 늘었음에도 위 매물을 소화하지 못했는데, 아커티스 바이오테라퓨틱스 ZORYVE FDA 승인 소식에 현재 프리마켓에서 전일 대비 +37%가량 주가가 상승 출발했습니다.
현재 주가 위로 단기 매물 부담은 약한 위치이기 때문에 장중 강한 변동성이 나타날 수 있는 자리인데, 아래 주봉차트상 중장기 매물대 저항이 강해 이를 돌파하기 위해서는 대량 거래가 필요해 보입니다.
그럼에도 불구하고 아커티스 바이오테라퓨틱스 ZORYVE FDA 승인 소식으로 인해 국내 투자자들 사이에서도 관심도가 높은 종목 중 하나입니다.
아커티스 바이오테라퓨틱스 주가 주봉차트를 보면 5달러 부근까지는 중장기 매물대 저항이 강하게 자리잡고 있는 것을 볼 수 있습니다.
이를 정규장에서 과연 돌파할 수 있을지, 아커티스 바이오테라퓨틱스 거래량이 얼마나 늘어나는지 체크해야 할 필요가 있을 것으로 보입니다.
아커티스 바이오테라퓨틱스 주가가 그동안 하락을 뒤로 하고 큰 폭으로 반등에 성공할 수 있을지, 계속해서 체크해 보도록 하겠습니다.