Aclaris Therapeutics provides update on three clinical trials for ATI-502

Aclaris Therapeutics provided updated data from three clinical trials for ATI-502, an investigational topical Janus kinase, or JAK, 1/3 inhibitor, an update on the expected release of topline data for one clinical trial for ATI-502, and an enrollment update for a clinical trial for ATI-501, an investigational oral JAK 1/3 inhibitor. AA-202 Topical and AUATB-201 Topical are ongoing Phase 2 clinical trials of ATI-502 for the treatment of alopecia areata, or AA, in the United States and Australia, respectively. In AA-202 Topical, 11 patients with the more severe forms of AA, alopecia universalis, or AU, and alopecia totalis, or AT, were treated with ATI-502 in an initial double-blind pharmacokinetic and pharmacodynamic study for 28 days before entering a 12-month open-label extension. In AUATB-201 Topical, an open-label clinical trial, 12 patients with eyebrow loss due to AA, including patients with AU or AT, had their eyebrows treated with ATI-502 for 6 months. VITI-201 Topical is an open-label pilot clinical trial of ATI-502 administered twice daily in 34 patients with non-segmental facial vitiligo. As announced in November, Aclaris completed enrollment of AA-201 Topical, a randomized, double-blinded, parallel-group, placebo-controlled trial to evaluate the safety, efficacy and dose response of two concentrations of ATI-502 for the treatment of AA. This trial enrolled 129 patients with patchy AA, who were randomized to receive either ATI-502 or placebo. The primary efficacy endpoint is the mean change from baseline in the severity of Alopecia tool, or SALT, score at Week 24. Topline data from the AA-201 Topical trial are now expected in Q2 of 2019. In addition, Aclaris announced that it has completed enrollment of AUAT-201 Oral, a randomized, double-blinded, parallel-group, placebo-controlled trial to evaluate the safety, efficacy and dose response of three concentrations of ATI-501 oral suspension for the treatment of AA. This trial enrolled 87 patients with AA, including AT and AU, who were randomized to receive either ATI-501 or placebo. The primary efficacy endpoint is the mean change from baseline in the SALT score at Week 24. Topline data from the AUAT-201 Oral trial are now expected in Q3 of 2019.

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