- Top-line Data Anticipated Around Year End
“We are very pleased to have completed the enrollment stage of our Phase 2b trial of ATI-1777 in atopic dermatitis, one of our two lead clinical development assets,” stated
ATI-1777 is a topical JAK inhibitor designed to minimize systemic exposure and delivered in a spray-on solution. The Phase 2b trial follows the successful four-week Phase 2a trial in moderate to severe atopic dermatitis which demonstrated meaningful improvement in the modified Eczema Area and Severity Index (EASI) and minimal measurable systemic exposure with a 2% formulation applied twice daily. The Phase 2b vehicle-controlled trial in atopic dermatitis further explores the concentration range (0.5%, 1% and 2%), as well as a once-daily regimen using the 2% formulation. The trial enrolled 250 patients with mild, moderate or severe AD, including adults and children as young as 12-years-old, across 34 clinical trial sites in the
ATI-1777 is an investigational topical “soft” Janus kinase (JAK) 1/3 inhibitor. “Soft” JAK inhibitors are designed to provide JAK inhibition at the site of application and be rapidly metabolized in systemic circulation. Aclaris plans to develop ATI-1777 as an emollient-containing spray formulation. Aclaris is developing ATI-1777 as a potential treatment for mild to severe atopic dermatitis. ATI-1777 is currently in clinical development, and its safety and efficacy have not been evaluated by regulatory authorities.
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 “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include Aclaris’ expectations regarding the timing of reporting results from ATI-1777-AD-202 and its Phase 2b trial of zunsemetinib (ATI-450) in rheumatoid arthritis, and Aclaris’ plans to develop ATI-1777 as an emollient-containing spray formulation for the potential treatment of atopic dermatitis, and other statements that are not historical fact. 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, Aclaris’ ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the macroeconomic environment 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
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Source: Aclaris Therapeutics, Inc.