WAYNE, Pa., June 28, 2018 (GLOBE NEWSWIRE) -- Aclaris Therapeutics (ACRS), Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, today announced positive interim data from its Phase 2 clinical trial (AA-202 Topical) of ATI-502 for the treatment of Alopecia Totalis (AT) or Alopecia Universalis (AU), the more severe variants of Alopecia Areata (AA). ATI-502, an investigational topical Janus Kinase (JAK) 1/3 inhibitor (ATI-502) is the most advanced topical JAK inhibitor in clinical trials for AT/AU in the United States. This randomized, double-blind clinical trial is being conducted at 2 study sites and will evaluate the pharmacokinetics, pharmacodynamics and safety of ATI-502 compared with vehicle in 11 patients with AT or AU over 28 days of treatment, followed by a 6-month open label period when all patients receive the drug.

AA is an autoimmune dermatologic condition typically characterized by patchy non-scarring hair loss on the scalp and body. More severe forms of AA are characterized by a total scalp hair loss (AT) or total hair loss on the scalp and body (AU). Today, we report interim results for 6 of the 11 enrolled patients; data from the full cohort will be reported in the future.

Pharmacokinetic Results:

• Systemic exposure was low as indicated by plasma drug levels that were below the limits of quantification (1ng/ml) in all subjects at day 28.
  • Consistent with low systemic exposure, no significant changes in circulating T, B and NK cells were observed at day 28.
• To assess skin penetration, punch biopsies were obtained at baseline and day 28 which demonstrated topical ATI-502 absorption consistent with pre-clinical skin models.
  • Mean of 5650 nanograms/gram at day 28 (range 3130 - 8170 ng/g).

Pharmacodynamic / RNA Sequencing Results: