- ATI-502 did not achieve statistical superiority at the primary or secondary endpoints due to high rates of disease resolution in vehicle-treated patients
AA-201 Topical, a Phase 2 randomized, double-blinded, parallel-group, vehicle-controlled trial, evaluated the safety, efficacy, and dose response of two concentrations of ATI-502, 0.12% and 0.46%, on the regrowth of hair in 129 subjects with AA. Subjects applied ATI-502 to their scalp twice daily for 24 weeks.
The primary endpoint was the mean percent 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.
ATI-502 was observed to be generally well-tolerated. Adverse events were primarily mild or moderate in severity. No treatment-related serious adverse events were reported.
“We are surprised and extremely disappointed by the results of this Phase 2 trial,” said Dr.
Company to Host Conference Call
Management will conduct a conference call at
To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 3497800 prior to the start of the call.
About Alopecia Areata
Alopecia areata (AA) 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. Onset of AA may occur in childhood and most patients experience onset by age 40. The course of disease is unpredictable and may involve spontaneous hair regrowth and sudden hair loss. Over half of patients with AA experience poor health-related quality of life. The disease can be associated with serious psychological consequences, including anxiety and depression. AA affects up to 1.8% of people in
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the development of Aclaris’ drug candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and in commercialization of products, Aclaris' reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Aclaris’ Annual Report on Form 10-K for the year ended
Senior Vice President
Corporate Strategy/Investor Relations
Source: Aclaris Therapeutics, Inc.