Aclaris Therapeutics, Inc. · NASDAQ:ACRS
Aclaris Therapeutics — Technical Presentation (June 2019)
15 slides from Aclaris Therapeutics's technical presentation, Jun 17, 2019
Slide 1: AGA-201 Data
AGA-201 Data Phase 2 open-label clinical trial evaluating the safety and efficacy of ATI-502, an investigational topical JAK1/3 inhibitor, on the regrowth of hair in patients with androgenetic alopecia (AGA), also known as male/female pattern hair loss. June 2019 EMPOWERING PATIENTS THROUGH REVELATI
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this presentation that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan," "pote
Slide 3: Androgenetic Alopecia (AGA): Male/Female pattern hair loss
AGA is a genetic disorder and the most common cause of hair loss1 Experienced by 70% of men and 40% of women at some point in their lives1; affects ~50 million men and ~30 million women in the US2 Affected individuals highly motivated to seek treatment1 Potential benefits of topical JAK inhibitor in
Slide 4: AGA – New Mechanism of Action Postulated
Tissue-resident immune cells with potent sensing and effector functions are well-placed to fundamentally aid tissue homeostasis via crosstalk with stem cells. A dermis-resident TREM2+ macrophage subpopulation that promotes hair follicle stem cell (HFSC) quiescence via cytokine-mediated JAK-STAT sign
Slide 5: AGA-201: Male and Female Subjects With AGA Treated With ATI-502
AGA-201: Male and Female Subjects With Androgenetic Alopecia (AGA) Treated With ATI-502 Eligibility AGA Diagnosis Males: Norwood-Hamilton Type III vertex, IV or V Females: Sinclair Grade 2, 3 or 4 ATI-502 (0.46%) BID Open-Label Study*1 Key Endpoints Primary Endpoint Change in non-vellus Total Area H
Slide 6: AGA-201: Primary Endpoint - Mean Change in Non-Vellus Target Area Hair Count
AGA-201: Primary Endpoint - Mean Change from Baseline in Non-Vellus Target Area Hair Count (TAHC) at Week 26 Primary Endpoint Mean (95%CI) = 8.6 (2.5, 14.6) Median (min, max) = 11.5 (-19.0, 27.0) N = 20 evaluable patients 6
Slide 7: AGA-201: Primary Endpoint By Gender
AGA-201: Primary Endpoint - Mean Change from Baseline in Non-Vellus Target Area Hair Count (TAHC) at Week 26 By Gender Primary Endpoint Male Mean (95%CI) = 5.6 (-2.2, 13.5) Male Median (min, max) = 6.5 (-19.0, 27.0) Female Mean (95%CI) = 15.3 (6.8, 23.9) Female Median (min, max) = 16.5 (1.0, 25.0) N
Slide 8: AGA-201: Secondary Endpoints - IGA and SSA
AGA-201: Secondary Endpoints - Investigator Global Assessment (IGA) and Subject Self-Assessment (SSA) Grade Description -3 Greatly decreased hair growth -2 Moderately decreased hair growth -1 Slightly decreased hair growth 0 No change +1 Slightly increased hair growth +2 Moderately increased hair gr
Slide 9: Subject 01-012 – Male
Subject 01-012 – 48 y/o Male IGA SSA TAHC Δ +3 +3 +11 Baseline Week 26 9
Slide 10: Subject 03-005 – Male
Subject 03-005 – 42 y/o Male IGA SSA TAHC Δ +1 +2 +24 Baseline Week 26 Baseline Week 26 10
Slide 11: Subject 01-029 – Female
Subject 01-029 – 31 y/o Female IGA SSA TAHC Δ +1 +2 +15 Baseline Week 26 11
Slide 12: Subject 02-002 – Female
Subject 02-002 – 41 y/o Female IGA SSA TAHC Δ +2 +1 +18 Baseline Week 26 12
Slide 13: Safety Summary
ATI-502 (0.46% concentration) was generally well-tolerated. No treatment-related serious adverse events (SAEs) reported in this study. One subject had an unrelated SAE of breast cancer which led to withdrawal of study medication. Three additional subjects had adverse events (AEs) leading to disconti
Slide 14: Next Steps
Design next clinical trial Positive advisory board meeting with leading hair loss KOLs reinforced plan for definitive Phase 2 study Double-blind, randomized, controlled Phase 2 clinical study with potentially female focus Dose range with higher concentrations of ATI-502 Market Research - assessment
Slide 15: Thank You
THANK YOU aclaris THERAPEUTICS BPE BDIS Acar Therapevtcs, inc. AX rights reserved
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