Aclaris Therapeutics, Inc. (ACRS) SEC Filing 10-Q Quarterly report for the period ending Friday, June 30, 2017

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A-101 40% Topical Solution

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Earlier this month, submitted a Marketing Authorization Application (MAA) for A-101 40% Topical Solution (A-101 40%) for the treatment of seborrheic keratosis (SK) with the Medicines Product Agency (MPA) in Sweden. The MPA will act as the reference member state in this decentralized procedure for review of the MAA for potential marketing approval throughout Europe. If approved, A-101 40% would be available to be commercialized in 16 countries in the European Union.  

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A-101 45% Topical Solution

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In June, initiated two Phase  2 clinical trials of A-101 45% Topical Solution (A-101 45%) for the treatment of common warts. The Phase 2b clinical trials are designed to evaluate the safety, tolerability and dose frequency of A-101 45% compared with its vehicle (placebo). Approximately 240 patients are expected to be randomized in the two double-blinded trials, which are being conducted at 30 investigational centers within the United States.

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JAK Inhibitors

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Continue plans to initiate a Phase 2 dose ranging trial of ATI-50001, an oral Janus kinase (JAK) inhibitor, for the treatment of alopecia totalis and alopecia universalis in the second half of 2017.

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Earlier this month, submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration for another JAK inhibitor, ATI-50002, for the treatment of patchy alopecia areata (AA). Following FDA clearance of the IND, Aclaris expects to initiate two Phase 2 clinical trials of ATI-50002, a topical Janus Kinase (JAK) 1/3 inhibitor in the second half of 2017.  These trials will be conducted at multiple investigational centers across the United States.

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Continue  plans to initiate a Phase 2 trial of ATI-50002 for the topical treatment of vitiligo in the second half of 2017. 

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Continue to develop another series of topical JAK inhibitors for the treatment of androgenetic alopecia (AGA).