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
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.
Apogee Therapeutics (NASDAQ:APGE) ha annunciato che i dati del suo trial di Fase 2 APEX su APG777 per dermatite atopica da moderata a grave saranno presentati al Congresso EADV 2025 a Parigi. La presentazione metterà in evidenza i dati principali a 16 settimane, che hanno raggiunto con successo gli endpoint primari e secondari.
APG777 si distingue come l'unico biologico in studio per intervalli di somministrazione di 3 e 6 mesi nel trattamento di mantenimento. L'azienda presenterà inoltre dati su APG990 e sulla loro strategia combinata con APG279, una coformulazione pensata per inibire le infiammazioni di Tipo 1, Tipo 2 e Tipo 3, potenzialmente ampliando la platea di pazienti.
Le presentazioni includono una sessione orale late-breaker della dott.ssa Emma Guttman-Yassky e tre poster che coprono il programma APEX, il profilo di sicurezza di APG990 e l'approccio della terapia combinata.
Apogee Therapeutics (NASDAQ:APGE) anunció que los datos de su ensayo de Fase 2 APEX de APG777 para dermatitis atópica de moderada a grave se presentarán en el Congreso EADV 2025 en París. La presentación destacará los datos principales a 16 semanas, que cumplieron con éxito los objetivos primarios y secundarios.
APG777 se diferencia por ser el único biológico que se está probando con intervalos de dosificación de 3 y 6 meses en el tratamiento de mantenimiento. La compañía también presentará datos sobre APG990 y su estrategia de combinación con APG279, una coformulación diseñada para inhibir la inflamación de Tipo 1, Tipo 2 y Tipo 3, lo que podría ampliar su alcance de pacientes.
Las presentaciones incluyen una sesión oral late-breaker a cargo de la Dra. Emma Guttman-Yassky y tres pósters que abordan el programa APEX, el perfil de seguridad de APG990 y el enfoque de terapia combinada.
Apogee Therapeutics (NASDAQ:APGE)는 중등도~중증 아토피 피부염 치료제 APG777의 2상 APEX 시험 결과가 2025년 파리에서 열리는 EADV 학회에서 발표될 것이라고 밝혔습니다. 발표에서는 성공적으로 1·2차 평가변수를 충족한 16주 주요 결과가 강조될 예정입니다.
APG777은 유지요법에서 3개월 및 6개월 투여 간격으로 시험되는 유일한 생물학적 치료제로 주목받고 있습니다. 회사는 또한 APG990에 대한 자료와, 1형·2형·3형 염증을 차단하도록 설계된 병용 제형인 APG279과의 병용 전략 데이터를 발표할 예정으로, 환자 적용 범위를 넓힐 가능성이 있습니다.
발표에는 Emma Guttman-Yassky 박사의 레이트브레이커 구두 발표와 APEX 프로그램, APG990의 안전성 프로파일, 병용요법 접근법을 다루는 세 편의 포스터 발표가 포함됩니다.
Apogee Therapeutics (NASDAQ:APGE) a annoncé que les données de son essai de phase 2 APEX sur APG777 pour la dermatite atopique modérée à sévère seront présentées au Congrès EADV 2025 à Paris. La présentation mettra en avant les données principales à 16 semaines, qui ont atteint avec succès les critères primaires et secondaires.
APG777 se distingue comme le seul biologique testé avec des intervalles d'administration de 3 et 6 mois en traitement d'entretien. La société présentera également des données sur APG990 et sur leur stratégie de combinaison avec APG279, une coformulation conçue pour inhiber l'inflammation de type 1, type 2 et type 3, élargissant potentiellement leur population de patients.
Les présentations comprennent une communication orale late‑breaker par la Dr. Emma Guttman‑Yassky et trois posters couvrant le programme APEX, le profil de sécurité d'APG990 et l'approche de thérapie combinée.
Apogee Therapeutics (NASDAQ:APGE) gab bekannt, dass Daten aus der Phase‑2‑Studie APEX von APG777 bei moderater bis schwerer atopischer Dermatitis auf dem EADV‑Kongress 2025 in Paris präsentiert werden. Die Präsentation wird die 16‑Wochen‑Topline‑Daten hervorheben, die die primären und sekundären Endpunkte erfolgreich erfüllten.
APG777 fällt dadurch auf, dass es das einzige Biologikum ist, das für Erhaltungsdosen in 3‑ und 6‑Monats‑Intervallen getestet wird. Das Unternehmen stellt zudem Daten zu APG990 sowie zu ihrer Kombinationsstrategie mit APG279 vor, einer Koformulierung, die Entzündungen vom Typ 1, Typ 2 und Typ 3 hemmen soll und damit potenziell die Patientenreichweite erweitert.
Zum Programm gehören eine Late‑Breaker‑Oralpräsentation von Dr. Emma Guttman‑Yassky sowie drei Posterpräsentationen zur APEX‑Studie, zum Sicherheitsprofil von APG990 und zum kombinierten Therapieansatz.
- 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
- None.
Insights
Apogee's APG777 shows promising Phase 2 results for atopic dermatitis with potential best-in-class efficacy and extended dosing intervals.
The Phase 2 APEX trial results for Apogee Therapeutics' APG777 represent a significant clinical advancement in atopic dermatitis treatment. Meeting both primary and secondary endpoints at the 16-week mark positions this novel anti-IL-13 antibody competitively in the inflammatory skin disease market. What's particularly noteworthy is the extended dosing interval - APG777 is being tested for maintenance dosing at 3-month and 6-month intervals, which would substantially reduce injection burden compared to current biologics that typically require dosing every 2-4 weeks.
The mechanistic approach targeting IL-13 builds upon established science, as IL-13 is a key driver of type 2 inflammation in atopic dermatitis. However, Apogee appears to have engineered substantial improvements in half-life extension, potentially allowing for the dramatically extended dosing intervals mentioned. This represents meaningful innovation rather than merely creating another me-too biologic.
Additionally, the company is pursuing a sophisticated combination strategy with APG990 (anti-OX40L antibody) and a coformulation called APG279 that could inhibit Type 1, Type 2, and Type 3 inflammation pathways. This multi-pathway approach could potentially address a broader patient population, including those who don't respond adequately to pure IL-13 inhibition. The healthy volunteer data for APG990 showing extended pharmacokinetics suggests the combination product could maintain the advantageous dosing profile.
The involvement of prominent dermatology experts like Dr. Emma Guttman-Yassky and Dr. Jonathan Silverberg as presenters lends scientific credibility to these findings. The late-breaker oral presentation slot at EADV further indicates the scientific community views these results as noteworthy and potentially practice-changing.
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?
How does APG777's dosing schedule differ from other atopic dermatitis biologics?
What is APG279 and how does it work?
When and where will Apogee present the APEX trial results?
What additional data will Apogee present at EADV 2025?
