Aclaris Therapeutics Announces Late-Breaking Abstract and Oral Presentation On ATI-2138 Phase 2a Results at the 2025 European Academy of Dermatology and Venereology (EADV) Congress

Rhea-AI Summary

Aclaris Therapeutics (NASDAQ:ACRS) announced that additional data from its Phase 2a trial of ATI-2138 in atopic dermatitis will be presented as a late-breaking abstract at the 2025 EADV Congress in Paris. ATI-2138 is a selective oral covalent inhibitor targeting ITK and JAK3 for moderate-to-severe atopic dermatitis treatment.

The presentation, titled "Molecular and Clinical Effects of oral ATI-2138," will be delivered by Dr. Jessica Beaziz-Tordjman on September 18, 2025, at 14:15 CEST. The study's results will provide insights into the drug's effectiveness in treating moderate-to-severe atopic dermatitis patients.

- Late Breaking Abstract to Present Additional Data from Aclaris’ Phase 2a Trial of ATI-2138 in Atopic Dermatitis-

WAYNE, Pa., Sept. 09, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that a late-breaking abstract on its open-label Phase 2a trial of ATI-2138, a potent and selective investigational oral covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase 3 (JAK3), was selected for oral presentation at the 2025 European Academy of Dermatology and Venereology (EADV) Congress, being held September 17-20, 2025, in Paris, France. The presentation will include additional results from Aclaris’ Phase 2a trial in patients with moderate-to-severe atopic dermatitis (AD).

Presentation Details:

Title		Molecular and Clinical Effects of oral ATI-2138, an ITK/JAK3 inhibitor, in Moderate-to-Severe Atopic Dermatitis: Sub-study of a Phase 2a Open-Label, Single-Arm Trial
Abstract ID		LBA-323
Session		D2T01.3A
Session Room		Paris Nord
Date		Thursday, September 18, 2025
Time		14:15 – 14:30 CEST
Presenter		Jessica Beaziz-Tordjman, M.D., French dermatologist and senior associate researcher, Laboratory for Inflammatory Skin Diseases, Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, NY.

About ATI-2138

ATI-2138 is a highly potent and selective novel investigational pharmacologic agent that acts as a dual inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase 3 (JAK3). ITK regulates T cell receptor signal transduction and inhibition of this kinase can affect T cell differentiation and activation. JAK3 is a key signal transduction kinase that forms a heterodimer with JAK1, modulates JAK1 phosphorylation of signal transducer and activator of transcription 5 (STAT5), and regulates cytokines that signal through the IL-2 receptor common gamma chain (IL-2ϒc) to affect lymphocyte proliferation and activation. The efficacy results exhibited in preclinical animal models of inflammation and autoimmune diseases, coupled with the favorable safety, PK, and PD profile in healthy human SAD and MAD studies and the top-line results of the Phase 2a trial in AD support the potential for ATI-2138 to affect several human inflammatory diseases and further investigation of this molecule in patients with atopic and autoimmune diseases that are dependent on T cell function and/or IL-2ϒc signaling.

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of product candidates powered by a robust R&D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on X (formerly Twitter) at @AclarisTx and on LinkedIn.

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 expectations regarding the therapeutic potential for ATI-2138. 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 December 31, 2024, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Aclaris Therapeutics Contact:

Will Roberts
Senior Vice President
Corporate Communications and Investor Relations
(484) 329-2125
wroberts@aclaristx.com

FAQ

What will be presented about ATI-2138 at the 2025 EADV Congress?

Additional results from Aclaris' Phase 2a trial of ATI-2138 in moderate-to-severe atopic dermatitis will be presented as a late-breaking abstract, focusing on the molecular and clinical effects of this oral ITK/JAK3 inhibitor.

When and where will Aclaris Therapeutics (ACRS) present their ATI-2138 data?

The presentation will take place on Thursday, September 18, 2025, from 14:15 to 14:30 CEST at the Paris Nord room during the EADV Congress in Paris, France.

Who will present the ATI-2138 clinical trial results for ACRS?

Dr. Jessica Beaziz-Tordjman, a French dermatologist and senior associate researcher from the Laboratory for Inflammatory Skin Diseases at Mount Sinai's Icahn School of Medicine, will present the results.

What is ATI-2138 and what is it being developed for?

ATI-2138 is a potent and selective investigational oral covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase 3 (JAK3), being developed for moderate-to-severe atopic dermatitis.