Aclaris Therapeutics, Inc. (ACRS) SEC Filing 10-Q Quarterly report for the period ending Friday, March 31, 2017

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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.