Apogee Therapeutics Announces Late-Breaker Presentation of 16-Week Data from Phase 2 APEX Trial of APG777 for Moderate-to-Severe Atopic Dermatitis at the Upcoming European Academy of Dermatology and Venereology (EADV) 2025 Congress

Rhea-AI Summary

Apogee Therapeutics (NASDAQ:APGE) announced that data from its Phase 2 APEX trial of APG777 for moderate-to-severe atopic dermatitis will be presented at the EADV Congress 2025 in Paris. The presentation will highlight the drug's 16-week topline data, which successfully met primary and secondary endpoints.

APG777 stands out as the only biologic being tested for 3- and 6-month dosing intervals in maintenance treatment. The company will also present data on APG990 and their combination strategy with APG279, a coformulation designed to inhibit Type 1, Type 2, and Type 3 inflammation, potentially expanding their patient reach.

The presentations include a late-breaker oral session by Dr. Emma Guttman-Yassky and three poster presentations covering the APEX program, APG990's safety profile, and the combination therapy approach.

Positive

• APG777 successfully met primary and secondary endpoints in Phase 2 APEX trial
• Only biologic being tested for extended 3- and 6-month dosing intervals, potentially reducing injection burden
• APG990 demonstrated extended PK and positive tolerability profile
• Strategic combination therapy (APG279) shows potential to target multiple inflammation types

Negative

• None.

SAN FRANCISCO and BOSTON, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today announced data from the Phase 2 APEX trial of APG777 for moderate-to-severe atopic dermatitis was accepted for a late-breaker oral presentation at the upcoming EADV Congress 2025, to be held in Paris, France from September 17-20, 2025. The Company will also present multiple poster presentations highlighting APG777’s best-in-class potential including data supporting its combination strategy.

“These presentations highlighting our lead program, APG777, and earlier stage programs, underscore our commitment to bringing new treatment options that provide strong efficacy and reduce injection burden for patients living with I&I conditions,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “In July, we announced 16-week topline data from the APEX clinical trial, in which APG777 met the primary and secondary endpoints, reinforcing its potentially best-in-class profile for moderate-to-severe atopic dermatitis as the only biologic being tested out to every 3- and 6-month dosing in maintenance. Additionally, previously reported healthy volunteer data of APG990 demonstrated an extended PK and positive tolerability profile, supporting our combination approach for this program with APG279, a coformulation of APG777 and APG990 that has the potential to inhibit Type 1, Type 2 and Type 3 inflammation, broadening the reach of patients we can potentially treat. We look forward to presenting these findings to the scientific community at EADV this year.”

EADV Congress 2025 Presentation Details:

Late-Breaker Oral Presentation:

Title: APG777, a Novel, Half-Life Extended Anti-IL-13 Antibody, Demonstrates Safety and Efficacy in Moderate-to-Severe Atopic Dermatitis: 16-Week Results from the Phase 2 APEX Study (D3T01.4A)
Presenter: Emma Guttman-Yassky, M.D., Ph.D., Waldman Professor of Dermatology and Immunology and Health System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City
Date/Time: Friday, September 19, 4:00pm CEST / 10:00am EST
Room: Paris Nord

Poster Presentations:

Title: APEX: An integrated phase 2 program evaluating APG777, a half-life extended anti-IL-13 monoclonal antibody, in atopic dermatitis (P0535)
Presenter: Jonathan I. Silverberg, M.D., Ph.D., MPH, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences
Location: Poster Area; Biologics, immunotherapy, targeted therapy
Date: Wednesday, September 17, 7:00am CEST / 1:00am EST

Title: APG990, a monoclonal antibody targeting OX40L, demonstrates safety and an extended half-life in healthy subjects (P3237)
Presenter: Carl Dambkowski, M.D., Chief Medical Officer, Apogee Therapeutics
Location: Poster Area; Biologics, immunotherapy, targeted therapy
Date: Wednesday, September 17, 7:00am CEST / 1:00am EST

Title: The Combination of APG777 (anti-IL-13) and APG990 (anti-OX40L) Provides Broad Suppression of Inflammatory Cytokines (P0536)
Presenter: Grant Wickman, Ph.D., Executive Director, Apogee Therapeutics
Location: Poster Area; Biologics, immunotherapy, targeted therapy
Date: Wednesday, September 17, 7:00am CEST / 1:00am EST

About Apogee
Apogee Therapeutics is a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest I&I markets, including for the treatment of Atopic Dermatitis (AD), asthma, Eosinophilic Esophagitis (EoE), Chronic Obstructive Pulmonary Disease (COPD), and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class profiles through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com.

Forward Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee’s plans for its current and future product candidates and programs; its planned clinical trial designs; its plans for current and future clinical trials; and the potential clinical benefit and half-life, PK profile and dosing regimen, and treatment outcomes of APG777, APG279, and APG990. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee’s filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025, filed with the SEC on August 11, 2025 and subsequent disclosure documents Apogee may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

Investor Contact:
Noel Kurdi
VP, Investor Relations
Apogee Therapeutics, Inc.
Noel.Kurdi@apogeetherapeutics.com

Media Contact:
Dan Budwick
1AB Media
dan@1abmedia.com

FAQ

What were the results of Apogee Therapeutics' (NASDAQ:APGE) Phase 2 APEX trial for APG777?

The Phase 2 APEX trial of APG777 for moderate-to-severe atopic dermatitis successfully met both primary and secondary endpoints in its 16-week topline data.

How does APG777's dosing schedule differ from other atopic dermatitis biologics?

APG777 is uniquely positioned as the only biologic being tested for 3- and 6-month dosing intervals in maintenance treatment, potentially reducing the injection burden for patients.

What is APG279 and how does it work?

APG279 is a coformulation of APG777 and APG990 designed to inhibit Type 1, Type 2, and Type 3 inflammation, potentially offering broader treatment coverage for patients with atopic dermatitis.

When and where will Apogee present the APEX trial results?

The results will be presented at the EADV Congress 2025 in Paris, France, from September 17-20, 2025, including a late-breaker oral presentation on September 19 at 4:00pm CEST.

What additional data will Apogee present at EADV 2025?

Apogee will present three poster presentations covering the APEX program, APG990's safety profile in healthy volunteers, and data supporting their combination therapy strategy.