Aclaris Therapeutics, Inc. · NASDAQ:ACRS
Aclaris Therapeutics — Technical Presentation (July 2019)
20 slides from Aclaris Therapeutics's technical presentation, Jul 30, 2019
Slide 1: AUAT-201 Data
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved AUAT-201 Data Phase 2 randomized, double-blinded, parallel- group, placebo-controlled trial, evaluated the safety, efficacy, and dose response of three doses of ATI-501 on
Slide 2: AUAT-201: Study Design
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved AUAT-201: Study Design Eligibility •AA Diagnosis • Stable AA, Alopecia Universalis or Alopecia Totalis • 30-100% total scalp hair loss (SALT) • 6 months -12 years in durati
Slide 3: Subject Disposition
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Subject Disposition Discontinued Reasons Completed (PP) = 70 Allocation Randomized Enrolled N=136 N=87 Pbo BID N=19 N=14 (74%) N=5 (26%) • AE 2 (11%) • Withdrew Consent 1 (
Slide 4: Demographics & Baseline Characteristics
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Demographics & Baseline Characteristics Pbo, BID N=19 400 mg, BID N=23 600 mg, BID N=23 800 mg, BID N=22 Age Mean (SD) 41.8 (16.01) 38.7 (12.99) 40.4 (13.56) 40.5 (12.44) S
Slide 5: Primary Endpoint
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Primary Endpoint 6% 30% 26% 26% 5
Slide 6: Secondary Endpoint
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Secondary Endpoint 8% 27% 27% 32% 6
Slide 7: Secondary Endpoint
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Secondary Endpoint 3% 15% 19% 21% 7
Slide 8: Secondary Endpoint
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Secondary Endpoint 17% 13% 25% 2% 8
Slide 9: Secondary Endpoint
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Secondary Endpoint 31% 25% 18% 3% 9
Slide 10: Overall Summary of Adverse Events (AEs)
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Overall Summary of Adverse Events (AEs) Placebo oral suspension (N=19) ATI-501 oral suspension 400 mg BID (N=23) ATI-501 oral suspension 600 mg BID (N=23) ATI-501 oral susp
Slide 11: Visit (Baseline) Visit (Month 6)
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Visit 2 (Baseline) Visit 9 (Month 6) • Male 35 yrs • 400mg BID • AA Disease = 1.0 yrs; Current Episode 1.0 yrs. • SALT 54% to 2% 11
Slide 12: Visit (Baseline) Visit (Month 6)
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Visit 2 (Baseline) Visit 9 (Month 6) 12
Slide 13: Visit (Baseline) Visit (Month 6)
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Visit 2 (Baseline) Visit 9 (Month 6) • Female 48 yrs • 600mg BID • AA Disease = 38.7 yrs; Current Episode 1.1 yrs • SALT 100% to 0%. 13
Slide 14: Visit (Baseline) Visit (Month 6)
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Visit 2 (Baseline) Visit 9 (Month 6) 14
Slide 15: Visit (Baseline) Visit (Month 6)
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Visit 2 (Baseline) Visit 9 (Month 6) 15
Slide 16: Visit (Baseline) Visit (Month 6)
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Visit 2 (Baseline) Visit 9 (Month 6) • Male 53 yrs • 800mg BID • AA Disease = 23.6 yrs; Current Episode 4.6 yrs. • SALT 100% to 17%. 16
Slide 17: Visit (Baseline) Visit (Month 6)
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Visit 2 (Baseline) Visit 9 (Month 6) 17
Slide 18: Visit (Baseline) Visit (Month 6)
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Visit 2 (Baseline) Visit 9 (Month 6) 18
Slide 19: Summary
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Summary • Subjects in each of the three ATI-501 active dose groups (400 mg, 600 mg and 800 mg) had statistically significant improvements compared to placebo for the primar
Slide 20: Thank You
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved THANK YOU
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