- Conference call to be held and accompanying slide deck with photos to be included with Current Report on Form 8-K
AA-202 Topical and AUATB-201 Topical are ongoing Phase 2 clinical trials of ATI-502 for the treatment of alopecia areata (AA) in
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 (SALT) score at Week 24. Topline data from the AA-201 Topical trial are now expected in the second quarter of 2019.
In addition, Aclaris announced today 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 the third quarter of 2019.
“AA can be a psychologically devastating disease for which many patients do not have adequate options for treatment. Inhibition of the JAK1 and JAK3 pathways is an emerging therapeutic approach. We continue to advance our development programs for oral and topical formulations of JAK inhibitors with the goal of addressing the full spectrum of disease severity for patients living with AA,” said Dr.
Aclaris to Host Conference Call
Management will conduct a conference call at 5:00 PM ET today to discuss these updates. The conference call will be webcast live over the Internet and can be accessed on the Events section of the Investors page of the Aclaris website at https://investor.aclaristx.com/events. A replay of the webcast will be archived on the Aclaris website for 30 days following the call. An accompanying slide deck with photos will be included as an exhibit to a Current Report on Form 8-K that Aclaris will furnish to the
To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 3119988 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 Aclaris’ clinical development of its drug candidates, including the timing for initiation and completion of planned clinical trials and the availability of data from these trials. 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, 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 filed for the year ended
Senior Vice President
Corporate Strategy/Investor Relations
Vice President, Corporate Communications
Source: Aclaris Therapeutics, Inc.