Aclaris Therapeutics Inc. (NASDAQ: ACRS) shares sharply dropped early on Thursday after the firm announced results from its midstage trial in alopecia areata. Unfortunately, the trial did not achieve statistical superiority at the primary or secondary endpoints, calling into question the future of the study.
The study was a Phase 2 clinical trial of ATI-502 and it did not reach statistical significance due to high rates of disease resolution in vehicle-treated patients. Alopecia areata is an autoimmune disease characterized by partial or complete loss of hair on the scalp, face or body. The scalp is the most commonly affected area.
The primary endpoint was the mean percentage change from baseline in the Severity of Alopecia Tool (SALT) score at week 24. Secondary endpoints included change in Alopecia Density and Extent (ALODEX) score and multiple investigator- and patient-reported outcomes.
Although it did not reach statistical significance, ATI-502 was generally well-tolerated and adverse events were primarily mild or moderate in severity.
Dr. Neal Walker, president and CEO of Aclaris, commented:
We are surprised and extremely disappointed by the results of this Phase 2 trial. This is disappointing not only for the company, but also for patients who are living with alopecia areata. We sincerely thank the patients and investigators who participated in this trial. We look forward to advancing our other development programs.
Shares of Aclaris closed Wednesday at $4.45, in a 52-week range of $4.26 to $21.97. The consensus price target is $19.83. Following the announcement, the stock was down 32% at $3.02 in early trading indications Thursday.