-=Aclaris Therapeutics (ACRS) : positive interim data from its Phase 2 study of ATI-502 for Alopecia Areata

Aclaris Therapeutics reports 'positive' interim data from its Phase 2 study of ATI-502 for Alopecia Areata 

The pharmacokinetic results include:

• 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.

Pharmacodynamic/RNA sequencing results include:

• Two patients had marked elevation of the interferon gamma and cytotoxic T-cell gene expression signatures at baseline: one received active drug and one received vehicle. At day 28, the patient on active drug demonstrated a positive change in the 2 biomarkers, while the patient on vehicle did not demonstrate a positive change in the 2 biomarkers.
• Two patients had low elevation of the interferon gamma and cytotoxic T-cell gene expression signatures at baseline: one received active drug, one received vehicle. At day 28 both patients showed a partial positive change in the 2 biomarkers.
• Two patients had no elevation of the interferon gamma and cytotoxic T-cell gene expression signatures at baseline: both patients received active drug. At day 28, neither patient showed any material change in the 2 biomarkers.

There were no serious adverse events reported during the 28-day dosing period. One subject receiving ATI-502 withdrew from the trial due to an unrelated SAE of major depression during the open label extension period.