Arcutis Biotherapeutics, Inc. · NASDAQ:ARQT
Arcutis Biotherapeutics — Technical Presentation (January 2022)
44 slides from Arcutis Biotherapeutics's technical presentation, January 2022
Slide 1: Arcutis Medical Affairs: Innovation in Dermatology
Arcutis Medical Affairs: Innovation in Dermatology Arcutis Biotherapeutics, Inc. is a medical dermatology company that champions meaningful innovation to solve the most persistent challenges of patients with immune-mediated dermatological diseases and conditions. Tap here to explore our pipeline For
Slide 2: Arcutis Is Building a Broad and Deep Dermatology Pipeline
Arcutis Is Building a Broad and Deep Dermatology Pipeline Preclinical Phase 1 Phase 2 Phase 3 NDA Submitted to FDA Plaque Psoriasis Roflumilast Cream (ARQ-151) Atopic Dermatitis Seborrheic PDE4 Inhibitor Dermatitis Roflumilast Foam Scalp and Body Psoriasis (ARQ-154) Chronic Hand Eczema ARQ-252 Cream
Slide 3: Roflumilast Is a Highly Potent PDE4 Inhibitor
Roflumilast Is a Highly Potent PDE4 Inhibitor1 Topical roflumilast is a selective and highly potent, nonsteroidal PDE4 inhibitor that is being investigated for the once-daily treatment of chronic plaque psoriasis, atopic dermatitis, seborrheic dermatitis, and scalp and body psoriasis PDE4 inhibition
Slide 4: Roflumilast Is a Highly Potent PDE4 Inhibitor
Roflumilast Is a Highly Potent PDE4 Inhibitor1 PDE4 plays a key role in immunodermatology PDE4 Topical roflumilast is a selective andis an enzyme highly that contributes potent, nonsteroidal, PDE4 to immunodermatologic conditions inhibitor that is being investigated for the once-daily treatment of c
Slide 5: Roflumilast Is a Highly Potent PDE4 Inhibitor
Roflumilast Is a Highly Potent Inhibition PDE4 Inhibitor 1 of PDE4 modulates the immune response in the skin Inhibition of PDE4 modulates immune responses by downregulating inflammatory Topical roflumilast is a selective and highly potent, nonsteroidal, PDE4 cytokines, inhibitor that is being invest
Slide 6: Roflumilast Cream (ARQ-151)
Roflumilast Cream (ARQ-151) Roflumilast cream (ARQ-151) is being investigated for the treatment of psoriasis and atopic dermatitis Roflumilast cream is uniquely formulated as an emollient, water-based (~50% water) cream without fragrances, propylene glycol, isopropyl alcohol, or ethanol Importantly,
Slide 7: Roflumilast Foam (ARQ-154)
Roflumilast Foam (ARQ-154) Roflumilast foam (ARQ-154) is being investigated for the treatment of seborrheic dermatitis and scalp and body psoriasis Roflumilast foam, which has a similar composition to roflumilast cream (ARQ- 151), is uniquely formulated as an emollient, water-based (~65% water) foam
Slide 8: Roflumilast Cream (ARQ-151) in Psoriasis
Roflumilast Cream (ARQ-151) in Psoriasis Landscape • High-potency steroids are limited to short-term use1 • Steroid-sensitive areas such as the face and intertriginous areas can be challenging to treat and require additional considerations1 Mechanism • Patients’ adherence to existing topical therapi
Slide 9: Roflumilast Cream (ARQ-151) in Psoriasis
Roflumilast Cream (ARQ-151) in Psoriasis Landscape Mechanism • PDE4 activity is elevated in psoriatic skin6 • Inhibition of PDE4 results in reduction of proinflammatory factors and restoration of skin barrier4 • Roflumilast cream (ARQ-151) is a selective and highly potent PDE4 inhibitor that is bein
Slide 10: Roflumilast Cream (ARQ-151) in Psoriasis
Roflumilast Cream (ARQ-151) in Psoriasis Landscape Development • Phase 1/2a results published in Journal of Drugs in Dermatology7 • Phase 2b results published in New England Journal of Medicine8 • Phase 2 long-term study is complete (NCT03764475) Mechanism • Two phase 3 studies are completed (NCT042
Slide 11: Phase 2b Study of Roflumilast Cream in Psoriasis
Roflumilast Cream (ARQ-151) in Psoriasis Landscape Phase 2b Study of Roflumilast Cream in Psoriasis DevelopmentRandomized, double-blind, vehicle-controlled multicenter study • Phase 2b results presented at AAD VMX 20205 1:1:1 ARQ-151 cream Endpoints Primary • Two Key phase 3 studies are ongoing Elig
Slide 12: Phase 2b Data for Roflumilast Cream in Psoriasis
Roflumilast Cream (ARQ-151) in Psoriasis Landscape Phase 2b Data for Roflumilast Cream in Psoriasis Roflumilast met its primary endpoint of statistically significant Development achievement of IGA 0 or 1 (clear or almost clear) at Week 6 • Phase 2b results presentedP<at0.001 AAD • Most patients with
Slide 13: Two Phase 3 Studies (DERMIS-1/-2) for Roflumilast Cream in Psoriasis
Roflumilast Cream (ARQ-151) in Psoriasis Landscape Two Phase 3 Studies (DERMIS-1/-2) for Roflumilast Cream Development in Psoriasis Have Been Completed1,2 • Phase 2b results presented at AAD VMX 20205 2:1 Endpoints Primary • Two Key phase 3 studies are ongoing Eligibility ARQ-151 cream • IGA success
Slide 14: Phase 3 Data for Roflumilast Cream in Psoriasis
Roflumilast Cream (ARQ-151) in Psoriasis Landscape Phase 3 Data for Roflumilast Cream in Psoriasis Roflumilast met its primary endpoint of statistically significant achievement of IGA success at Week 8a Development • Approximately 3 out of 4 patients with • Phase 2b results presented at AAD intertri
Slide 15: Roflumilast Cream (ARQ-151) in Atopic Dermatitis
For Use in Scientific Exchange and Medical Affairs Discussion Only. Do Not Copy, Distribute or Use in Any Promotional Manner. Roflumilast Cream (ARQ-151) in Atopic Dermatitis Landscape • Atopic dermatitis is a common chronic inflammatory skin disease that affects both children and adults1 • Itch is
Slide 16: Roflumilast Cream (ARQ-151) in Atopic Dermatitis
Roflumilast Cream (ARQ-151) in Atopic Dermatitis Landscape Mechanism • Elevated PDE4 levels are found in the keratinocytes of individuals with atopic dermatitis3 • PDE4 inhibition decreases inflammatory response and pruritus3,4 • Roflumilast cream (ARQ-151) is a selective and highly potent PDE4 inhi
Slide 17: Roflumilast Cream (ARQ-151) in Atopic Dermatitis
Roflumilast Cream (ARQ-151) in Atopic Dermatitis Landscape Development • Phase 2 study has been completed (NCT03916081) • Two identical phase 3 studies are ongoing (INTEGUMENT-1: NCT04773587; Mechanism INTEGUMENT-2: NCT04773600) • A phase 3 trial in pediatric patients aged 2-5 years is ongoing (INTE
Slide 18: Phase 2 Study of Roflumilast Cream in Atopic Dermatitis
Roflumilast Cream (ARQ-151) in Psoriasis Landscape Phase 2 Study of Roflumilast Cream in Atopic Dermatitis DevelopmentRandomized, double-blind, vehicle-controlled multicenter study • Phase 2b results presented at AAD VMX 20205 1:1:1 ARQ-151 cream Endpoints Primary • Two Key phase 3 studies are ongoi
Slide 19: Phase 2 Study of Roflumilast Cream in Atopic Dermatitis
Roflumilast Cream (ARQ-151) in Psoriasis Landscape Phase 2 Study of Roflumilast Cream in Atopic Dermatitis Development Absolute EASI •change Phasefrom EASI percent 2b results presented at AAD vIGA-AD score of baseline (primary endpoint) VMX Week 4 20205 change from baseline EASI-75 responder rate cl
Slide 20: Two Phase 3 Studies (INTEGUMENT-1/-2) Are Ongoing in Atopic Dermatitis
Roflumilast Cream (ARQ-151) in Psoriasis Landscape Two Phase 3 Studies (INTEGUMENT-1/-2) Are Ongoing for Roflumilast Cream in Atopic Dermatitis1,2 Development • Phase 2b results presented at 2:1AAD Endpoints VMX 20205 Primary Key Eligibility ARQ-151 cream • IGA success at Week 4a • Two phase 3 studi
Slide 21: Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis
Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis Landscape • Seborrheic dermatitis typically appears as erythematous patches on the scalp and face1 • Seborrheic dermatitis is associated Mechanism with itch and reduced quality of life1,2 • Current treatments include topical antifungals and cortico
Slide 22: Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis
Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis Landscape Mechanism • Roflumilast is a selective, highly potent, antiinflammatory PDE4 inhibitor that is being investigated for the reduction of itching and flaking of the skin • Its foam formulation may allow for use on all parts of the body, incl
Slide 23: Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis
Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis Landscape Development • Phase 2b study has been completed (NCT04091646) • A long-term safety study is ongoing (NCT04445987) Mechanism • A phase 3 study is ongoing (STRATUM; NCT04973228) Click to learn more about clinical trials of topical roflumila
Slide 24: Phase 2b Proof-of-Concept Study of Roflumilast Foam in Seborrheic Dermatitis
Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis Phase 2b Proof-of-Concept StudyLandscape of Roflumilast Foam in Seborrheic Dermatitis1,2 DevelopmentRandomized, double-blind, vehicle-controlled multicenter study • PhasPhase 2b study is ongoing (NCT04091646) 2:1 Endpoints Primary • Open-label long
Slide 25: Phase 2b Data for Roflumilast Foam in Seborrheic Dermatitis
Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis Phase 2b Data for Roflumilast Foam in Landscape Seborrheic Dermatitis Roflumilast met its primary endpoint of statistically significant Development achievement of IGA 0 or 1 (clear or almost clear) at Week 8 • PhasPhase 2b study is ongoing P<0.0001
Slide 26: Phase 3 Study of Roflumilast Foam in Seborrheic Dermatitis (STRATUM)
Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis A Phase 3 Study of Roflumilast Foam in Seborrheic Landscape Dermatitis (STRATUM) Is Ongoing DevelopmentRandomized, double-blind, vehicle-controlled multicenter study • PhasPhase 2b study is ongoing (NCT04091646) 2:1 Endpoints Key Eligibility Primar
Slide 27: Roflumilast Foam (ARQ-154) in Scalp and Body Psoriasis
Roflumilast Foam (ARQ-154) in Scalp and Body Psoriasis Landscape • Scalp psoriasis is characterized by silvery-white scales and is often the first manifestation of psoriasis on the body1 Mechanism • Patient with scalp psoriasis experience reduced quality of life due to itch and embarrassment1 • Many
Slide 28: Roflumilast Foam (ARQ-154) in Scalp and Body Psoriasis
Roflumilast Foam (ARQ-154) in Scalp and Body Psoriasis Landscape Mechanism • PDE4 activity is elevated in psoriatic skin2 • Roflumilast is a highly potent antiinflammatory, antipruritic PDE4 inhibitor • Foam formulation may allow for use on all parts of the body, including hair-bearing areas Develop
Slide 29: Roflumilast Foam (ARQ-154) in Scalp and Body Psoriasis
Roflumilast Foam (ARQ-154) in Scalp and Body Psoriasis Landscape Development • Phase 2b trial for scalp and body psoriasis has been completed (NCT04128007) • A phase 3 study is ongoing (ARRECTOR; Mechanism NCT05028582) Click to learn more about clinical trials of topical roflumilast: Learn more 1. M
Slide 30: Phase 2b Study of Roflumilast Foam in Scalp and Body Psoriasis
Roflumilast Foam (ARQ-154) in Scalp Psoriasis Landscape Phase 2b Study of Roflumilast Foam in Scalp and Body Psoriasis DevelopmentRandomized, double-blind, vehicle-controlled multicenter study • Phase 2b trial is ongoing (NCT04128007) Key Eligibility 2:1 Endpoints Primary • Diagnosis of at least ARQ
Slide 31: Phase 2b Data for Roflumilast Foam in Scalp and Body Psoriasis
Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis Phase 2b Data for Roflumilast Foam in Landscape Scalp and Body Psoriasis Roflumilast met its primary endpoint of statistically significant Development achievement of S-IGA 0 or 1 (clear or almost clear) at Week 8 • At Week 8, significantly more pat
Slide 32: Phase 3 Study of Roflumilast Foam in Scalp and Body Psoriasis (ARRECTOR)
Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis A Phase 3 Study of Roflumilast Foam in Scalp and Landscape Body Psoriasis (ARRECTOR) Is Ongoing Development Randomized, double-blind, vehicle-controlled multicenter study • PhasPhase 2b study is ongoing Key Eligibility (NCT04091646) • Aged ≥12 y 2:
Slide 33: JAK1 Inhibitors ARQ-252 and ARQ-255
JAK1 Inhibitors ARQ-252 and ARQ-255 ARQ-252 is a selective and highly potent topical JAK1 inhibitor that is being investigated as a cream for the treatment of chronic hand eczema and vitiligo ARQ-252 demonstrates greater potency for JAK1 than JAK2,1 which may avoid hematological adverse effects typi
Slide 34: JAK1 Inhibitors ARQ-252 and ARQ-255
JAK1 Inhibitors ARQ-252 and ARQ-255 Role of JAK1 in immunomodulation ARQ-252 is a selective and highly potent topical JAK1 inhibitor under investigated as a cream for the treatment of hand eczema and vitiligo JAK-dependent cytokines contribute to immunodermatologic conditions1,2 ARQ-252 demonstrates
Slide 35: JAK1 Inhibitors ARQ-252 and ARQ-255
JAK1 Inhibitors ARQ-252 and ARQ-255 Selective JAK1 inhibition modulates immunodermatology pathways ARQ-252 is a selective and highly potent topical JAK1 inhibitor under investigated as a cream for the treatment of hand Selective JAK1eczema and vitiligo inhibition modulates or reduces the activity of
Slide 36: Topical JAK1 Inhibitor Cream (ARQ-252) in Chronic Hand Eczema
Topical JAK1 Inhibitor Cream (ARQ-252) in Chronic Hand Eczema Landscape • Chronic hand eczema is a common condition that occurs in different forms1 • Chronic hand eczema negatively affects Mechanism quality of life and incurs a substantial economic burden (eg, reduced work productivity)2,3 • There i
Slide 37: Topical JAK1 Inhibitor Cream (ARQ-252) in Chronic Hand Eczema
Topical JAK1 Inhibitor Cream (ARQ-252) in Landscape Chronic Hand Eczema Mechanism • Inhibition of JAK has been shown to reduce pruritus in vivo4 • ARQ-252 is a selective and highly potent topical, small molecule JAK1 inhibitor that is being investigated as a treatment for chronic hand eczema Develop
Slide 38: Topical JAK1 Inhibitor Cream (ARQ-252) in Chronic Hand Eczema
Topical JAK1 Inhibitor Cream (ARQ-252) in Landscape Chronic Hand Eczema Development • Phase 1/2b study is complete (NCT04378569) • The primary endpoint was not met, with none of the ARQ-252 cohorts achieving Mechanism statistical significance vs vehicle • No unexpected safety findings were identifie
Slide 39: Topical JAK1 Inhibitor Cream (ARQ-252) in Vitiligo
Topical JAK1 Inhibitor Cream (ARQ-252) in Vitiligo Landscape1 • Physician-recommended therapies include narrow band ultraviolet B, tacrolimus, and topical steroids • Only monobenzone is approved for Mechanism vitiligo to remove pigment from the skin in order to make the skin color more even • Becaus
Slide 40: Topical JAK1 Inhibitor Cream (ARQ-252) in Vitiligo
Topical JAK1 Inhibitor Cream (ARQ-252) Landscape in Vitiligo Mechanism • Inhibition of the JAK-STAT pathway induces successful repigmentation in vitiligo2 • ARQ-252 is a selective and highly potent topical, small molecule JAK1 inhibitor that is being investigated as a treatment for vitiligo Developm
Slide 41: Topical JAK1 Inhibitor Cream (ARQ-252) in Vitiligo
Topical JAK1 Inhibitor Cream (ARQ-252) Landscape in Vitiligo Development • Phase 2a trial has been terminated (NCT04811131) • Decision was based on analyses of the formulation used in both this vitiligo study and the recently completed Mechanism phase 2b chronic hand eczema study • Analyses of the c
Slide 42: Topical JAK1 Inhibitor Suspension (ARQ-255) in Alopecia Areata
Topical JAK1 Inhibitor Suspension (ARQ-255) in Alopecia Areata Landscape1,2 • There are currently no approved therapies for alopecia areata • Because of unpredictable and spontaneous remission, optimal Mechanism duration of therapy and therapeutic dosing regimens have not been well characterized Dev
Slide 43: Topical JAK1 Inhibitor Suspension (ARQ-255) in Alopecia Areata
Topical JAK1 Inhibitor Suspension (ARQ-255) Landscape in Alopecia Areata Mechanism • JAK-STAT inhibition is a promising target for the treatment of alopecia areata3 • ARQ-255 is a selective and highly potent topical, small molecule JAK1 inhibitor formulated to deliver drug deep into the dermis that
Slide 44: Topical JAK1 Inhibitor Suspension (ARQ-255) in Alopecia Areata
Topical JAK1 Inhibitor Suspension (ARQ-255) Landscape in Alopecia Areata Development • Preclinical Mechanism 1. Wagner. J Invest Derm Symp P. 2015;17:67-69. 2. Fricke and Miteva. Clin Cosmet Investig Dermatol. 2015;8:397-403. 3. Triyangkulsri and Suchonwanit. Drug Des Devel Ther. 2018:12. For Use in
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