Arcutis Biotherapeutics, Inc. · NASDAQ:ARQT
Arcutis Biotherapeutics — Investor Presentation (September 2020)
39 slides from Arcutis Biotherapeutics's investor presentation, September 2020
Slide 1: Arcutis: Innovation in Dermatology
Arcutis: Innovation in Dermatology At Arcutis, we are filling the innovation gap in dermatology by developing best-in-class, innovative topical dermatology therapies against validated biological targets and elevating the standard of care. Our goals are to simplify disease management and provide more
Slide 2: Arcutis Is Building a Robust Dermatology Pipeline
Arcutis Is Building a Robust Dermatology Pipeline Preclinical Phase 1 Phase 2 Phase 3 Plaque Psoriasis Roflumilast Cream (ARQ-151) Atopic Dermatitis Seborrheic PDE4 Inhibitor Dermatitis Roflumilast Foam Scalp Psoriasis (ARQ-154) Hand Eczema ARQ-252 Cream Vitiligo JAK1 Inhibitor Alopecia Areata ARQ-2
Slide 3: Roflumilast is a Highly Selective Topical PDE4 Inhibitor
Roflumilast is a Highly Selective Topical PDE4 Inhibitor Topical roflumilast is a selective and highly potent, once-daily, nonsteroidal, PDE4 inhibitor under investigation for the treatment of chronic plaque psoriasis, atopic dermatitis, seborrheic dermatitis, and scalp psoriasis PDE4 inhibition has
Slide 4: PDE4 plays a key role in immunodermatology
Roflumilast is a Highly Selective Topical PDE4 Inhibitor PDE4 plays a key role in immunodermatology PDE4 Topical roflumilast is a selective andis an enzyme highly that contributes potent, once-daily, nonsteroidal,to immunodermatologic conditions PDE4 inhibitor under investigation for the treatment o
Slide 5: Inhibition of PDE4 modulates the immune response
Roflumilast is a Highly Selective Topical PDE4 Inhibitor Inhibition of PDE4 modulates the immune response Topical roflumilast is a selective and highly Inhibition of PDE4 potent, once-daily, modulates immune responses nonsteroidal, PDE4 inhibitor under investigation for the treatment of chronic plaq
Slide 6: Roflumilast Cream (ARQ-151)
Roflumilast Cream (ARQ-151) Roflumilast cream (ARQ-151) is under investigation for the treatment of psoriasis and atopic dermatitis Uniquely formulated in an odorless, emollient, water-based moisturizing cream without propylene glycol or alcohols Cream vehicle incorporates a mild emulsifier, providi
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 psoriasis Roflumilast foam is identical to roflumilast cream (ARQ-151) and is water based, moisturizing, and formulated without propylene glycol or alcohols Foam vehicle i
Slide 8: Roflumilast Cream (ARQ-151) in Psoriasis: Landscape
Roflumilast Cream (ARQ-151) in Psoriasis Landscape • High-potency steroids are limited to short-term use1 • Sensitive areas such as the face and intertriginous areas can be Mechanism challenging to treat and require additional considerations1 • Patient adherence to existing topical therapies is gene
Slide 9: Roflumilast Cream (ARQ-151) in Psoriasis: Mechanism
Roflumilast Cream (ARQ-151) in Psoriasis Landscape Mechanism • PDE4 activity is elevated in psoriatic skin4 • Inhibition of PDE4 results in reduction of proinflammatory factors and restoration of skin barrier2 • Roflumilast cream (ARQ-151) is a selective and highly potent PDE4 inhibitor Development
Slide 10: Roflumilast Cream (ARQ-151) in Psoriasis: Development
Roflumilast Cream (ARQ-151) in Psoriasis Landscape Development • Phase 1/2a results published in Journal of Drugs in Dermatology5 • Phase 2b results published in New England Journal of Medicine6 • Two phase 3 studies are ongoing Mechanism (NCT04211363; NCT04211389) • A phase 3 open-label extension s
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 phase 3 studies are ongoing Eligibil
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 b
Slide 13: Two Phase 3 Studies (DERMIS-1/-2) Are Ongoing in Psoriasis
Roflumilast Cream (ARQ-151) in Psoriasis Landscape Two Phase 3 Studies (DERMIS-1/-2) Are Ongoing for Roflumilast Cream in Psoriasis1,2 Development • Phase 2b results presented at AAD VMX 20205 2:1 Endpoints Primary • Two phase 3 studies are ongoing Eligibility ARQ-151 cream • IGA successa (NCT042113
Slide 14: Roflumilast Cream (ARQ-151) in Atopic Dermatitis: Landscape
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 the most burdensome symptom, causing patients to experience substantially reduced quality of life and Mechanism sleep disturba
Slide 15: Roflumilast Cream (ARQ-151) in Atopic Dermatitis: Mechanism
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 16: Roflumilast Cream (ARQ-151) in Atopic Dermatitis: Development
Roflumilast Cream (ARQ-151) in Atopic Dermatitis Landscape Development • Phase 2 study completed (NCT03916081) • Phase 3 study planned Mechanism Click to learn more about clinical trials of topical roflumilast: Learn more 1. Data on file, Arcutis BioSciences. 2. Silverberg et al. Ann Allergy Asthma
Slide 17: 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 phase 3 studies are ongoing E
Slide 18: Clinical Development of Roflumilast Cream in Atopic Dermatitis
Roflumilast Cream (ARQ-151) in Psoriasis Landscape Clinical Development of Development Roflumilast Cream in Atopic Dermatitis • Phase 2b results presented at AAD VMX 20205A phase 2 proof-of-concept study showed Both 0.05% and 0.15% doses showed consistent evidence of symptomatic statistically signif
Slide 19: Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis: Landscape
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 20: Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis: Mechanism
Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis Landscape Mechanism • Roflumilast is a selective and highly potent anti-inflammatory PDE4 inhibitor that may reduce itch and flaking of the skin • Foam formulation allows for use on all parts of the body, including hair- bearing areas Development 1
Slide 21: Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis: Development
Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis Landscape Development • Phase 2b study is ongoing (NCT04091646) • Open-label long-term study is ongoing (NCT04445987) Mechanism Click to learn more about clinical trials of topical roflumilast: Learn more 1. Clark et al. Am Fam Physician. 2015;91:1
Slide 22: Proof-of-Concept Study of Roflumilast Foam in Seborrheic Dermatitis
Roflumilast Foam (ARQ-154) in Seborrheic Dermatitis Phase 2 Proof-of-Concept StudyLandscape of Roflumilast Foam in Seborrheic Dermatitis DevelopmentRandomized, double-blind, vehicle-controlled multicenter study • PhasPhase 2b study is ongoing (NCT04091646) 2:1 Endpoints Primary • Open-label long-ter
Slide 23: Roflumilast Foam (ARQ-154) in Scalp Psoriasis: Landscape
Roflumilast Foam (ARQ-154) in Scalp 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 topical
Slide 24: Roflumilast Foam (ARQ-154) in Scalp Psoriasis: Mechanism
Roflumilast Foam (ARQ-154) in Scalp Psoriasis Landscape Mechanism • PDE4 activity is elevated in psoriatic skin2 • Roflumilast is a highly potent anti- inflammatory, antipruritic PDE4 inhibitor • Foam formulation allows for use on all parts of the body, including hair-bearing areas Development 1. Me
Slide 25: Roflumilast Foam (ARQ-154) in Scalp Psoriasis: Development
Roflumilast Foam (ARQ-154) in Scalp Psoriasis Landscape Development • Phase 2b trial is ongoing (NCT04128007) Mechanism Click to learn more about clinical trials of topical roflumilast: Learn more 1. Merola et al. Dermatol Ther. 018;31:e12589. 2. Li et al. Front Pharmacol. 2018;9:1048.
Slide 26: Phase 2b Study of Roflumilast Foam in Scalp Psoriasis
Roflumilast Foam (ARQ-154) in Scalp Psoriasis Landscape Phase 2b Study of Roflumilast Foam in Scalp Psoriasis DevelopmentRandomized, double-blind, vehicle-controlled multicenter study • Phase 2b trial is ongoing (NCT04128007) Eligibility 2:1 Endpoints Primary • Diagnosis of at least ARQ-154 foam • S
Slide 27: 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 under investigation as a cream for the treatment of hand eczema and vitiligo ARQ-252 demonstrates greater potency for JAK1 than JAK2,1 which may avoid hematological adverse effects typically associate
Slide 28: Role of JAK1 in immunomodulation
JAK1 Inhibitors ARQ-252 and ARQ-255 Role of JAK1 in immunomodulation ARQ-252 is a selective and highly potent topical JAK1 inhibitor under investigation as a cream for the treatment of hand eczema and vitiligo JAK-dependent cytokines contribute to immunodermatologic conditions1,2 ARQ-252 demonstrate
Slide 29: Selective JAK1 inhibition modulates immunodermatology pathways
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 investigation as a cream for the treatment of hand Selective JAK1eczema and vitiligo inhibition modulates or reduces the activity o
Slide 30: Topical JAK Inhibitor Cream (ARQ-252) in Hand Eczema: Landscape
Topical JAK Inhibitor Cream (ARQ-252) in 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 is a consi
Slide 31: Topical JAK Inhibitor Cream (ARQ-252) in Hand Eczema: Mechanism
Topical JAK Inhibitor Cream (ARQ-252) in Hand Eczema Landscape Mechanism • JAK inhibition, including JAK1, has been shown to reduce pruritus4 • ARQ-252 is a selective and highly potent topical, small molecule JAK1 inhibitor Development 1. Diepgen et al. Br J Dermatol. 2009;160:353-358. 2. Bingefors
Slide 32: Topical JAK Inhibitor Cream (ARQ-252) in Hand Eczema: Development
Topical JAK Inhibitor Cream (ARQ-252) in Hand Eczema Landscape Development • Phase 1/2b study is ongoing (NCT04378569) Mechanism Click to learn more about clinical trials of topical JAK inhibition: Learn more 1. Diepgen et al. Br J Dermatol. 2009;160:353-358. 2. Bingefors et al. Acta Derm Venereol.
Slide 33: Phase 1/2b Study Design of Topical JAK Inhibitor Cream in Hand Eczema
Roflumilast Foam (ARQ-154) in Scalp Psoriasis Landscape Phase 1/2b Study Design of Topical JAK Inhibitor Cream in Hand Eczema DevelopmentRandomized, Double-blind, Vehicle-controlled Multicenter Study • Phase 2b trial is ongoing Cohort 1 Primary endpoints (NCT04128007) ARQ-252 cream 0.3% QD • Inciden
Slide 34: Topical JAK Inhibitor Cream (ARQ-252) in Vitiligo: Landscape
Topical JAK Inhibitor Cream (ARQ-252) in Vitiligo Landscape1 • Recommended therapies include narrow band ultraviolet B, tacrolimus, and topical steroids • As there are limited treatment options Mechanism available to treat vitiligo, there is a critical need for safe and effective drug therapies for
Slide 35: Topical JAK Inhibitor Cream (ARQ-252) in Vitiligo: Mechanism
Topical JAK Inhibitor Cream (ARQ-252) in Vitiligo Landscape 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 Development 1. Ezzedine et al. Lancet. 2015; 386:74-84. 2. Liu e
Slide 36: Topical JAK Inhibitor Cream (ARQ-252) in Vitiligo: Development
Topical JAK Inhibitor Cream (ARQ-252) in Vitiligo Landscape Development • Phase 2a planned Mechanism 1. Ezzedine et al. Lancet. 2015; 386:74-84. 2. Liu et al. Am Acad Dermatol. 2017;77:675-682.
Slide 37: Topical Roflumilast Suspension (ARQ-255) in Alopecia Areata: Landscape
Topical Roflumilast 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 Develo
Slide 38: Topical Roflumilast Suspension (ARQ-255) in Alopecia Areata: Mechanism
Topical Roflumilast Suspension (ARQ-255) in Alopecia Areata Landscape 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 Developm
Slide 39: Topical Roflumilast Suspension (ARQ-255) in Alopecia Areata: Development
Topical Roflumilast Suspension (ARQ-255) in Alopecia Areata Landscape 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.
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