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Exhibit 99.1
Aclaris Therapeutics Reports First Quarter 2017 Financial Results
Management to Host Conference Call at 4:30 PM ET today
Malvern, PA – May 9, 2017 (GLOBE NEWSWIRE) – Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a dermatologist-led biotechnology company, today announced financial results for the first quarter of 2017 and provided an update on its clinical development programs.
“The start of 2017 has been a busy one for Aclaris and we are pleased the momentum from last year has continued into the first quarter of this year,” commented Dr. Neal Walker, President and Chief Executive Officer of Aclaris. “Our New Drug Application (NDA) for A-101 40% Topical Solution (A-101 40%) for the treatment of seborrheic keratosis (SK) was accepted for review by the U.S. Food and Drug Administration (FDA). We continue to advance our pipeline and broaden our intellectual property estate as we focus our efforts on developing innovative treatments for patients.”
Clinical Pipeline Update
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A-101 40% Topical Solution |
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The NDA for A-101 40% for the topical treatment of SK has been accepted by the FDA for review. |
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The NDA contains data from three Phase 3 trials that included more than 1,000 patients. |
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Plan to submit a marketing authorization application (MAA) for A-101 40% for the treatment of SK in the European Union in the second half of 2017. |
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A-101 45% Topical Solution |
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Plan to initiate two Phase 2 clinical trials of A-101 45% Topical Solution (A-101 45%) for the treatment of common warts in mid-2017. |
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JAK Inhibitor |
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Recently completed a Phase 1 clinical trial of ATI-50001, an investigational oral Janus Kinase (JAK) 1/3 inhibitor. This Phase 1 cross-over trial was conducted in 12 healthy volunteers at one investigational center in the United States to assess safety, bioavailability, and pharmacodynamics. |
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In the Phase 1 trial, treatment with ATI-50001 capsules was well tolerated. No clinically significant laboratory abnormalities were observed. These data are consistent with results from an earlier Phase 1 clinical trial in 44 healthy volunteers conducted by Rigel Pharmaceuticals in which the study drug was well tolerated at all doses. |
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Plan to initiate a Phase 2 dose ranging trial with ATI-50001 for the oral treatment of alopecia totalis and alopecia universalis in the second half of 2017. |
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In addition, Aclaris also plans to develop an investigational topical JAK 1/3 inhibitor, known as ATI-50002, for the treatment of AA and vitiligo. |
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Plan to submit an Investigational New Drug application (IND) for ATI-50002 for the topical treatment of patchy AA in mid-2017. |
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