Apogee Therapeutics Announces First Patient Dosed in Part B of Phase 2 APEX Trial of APG777 in Patients with Moderate-to-Severe Atopic Dermatitis
Apogee Therapeutics (NASDAQ: APGE) announced significant progress in its Phase 2 APEX clinical trial of APG777 for moderate-to-severe atopic dermatitis (AD). The company has completed Part A enrollment ahead of schedule with 123 patients, exceeding the target of 110 patients, and has begun dosing patients in Part B.
The trial evaluates APG777, a novel subcutaneous extended half-life monoclonal antibody targeting IL-13. Part A randomized patients 2:1 to APG777 versus placebo, with APG777 patients receiving 720mg at weeks 0 and 2, followed by 360mg at weeks 4 and 12. Part B will involve approximately 280 patients randomized 1:1:1:1 to high, medium, or low dose APG777 versus placebo.
Key upcoming milestones include Part A 16-week data in mid-2025, maintenance data in H1 2026, and Part B 16-week data in H2 2026. The company also plans to initiate Phase 1b trials in asthma and a combination study with APG990 in 2025.
Apogee Therapeutics (NASDAQ: APGE) ha annunciato progressi significativi nel suo studio clinico di Fase 2 APEX riguardante APG777 per la dermatite atopica (AD) da moderata a grave. L'azienda ha completato l'arruolamento della Parte A con 123 pazienti, anticipando i tempi previsti, superando l'obiettivo di 110 pazienti, e ha iniziato a somministrare il trattamento ai pazienti nella Parte B.
Lo studio valuta APG777, un nuovo anticorpo monoclinale sottocutaneo con emivita prolungata che agisce contro l'IL-13. Nella Parte A, i pazienti sono stati randomizzati in un rapporto 2:1 tra APG777 e placebo, con i pazienti trattati con APG777 che ricevevano 720mg alle settimane 0 e 2, seguiti da 360mg alle settimane 4 e 12. La Parte B coinvolgerà circa 280 pazienti randomizzati in un rapporto 1:1:1:1 per ricevere un'alta, media o bassa dose di APG777 rispetto al placebo.
Le principali milestone in arrivo includono dati della Parte A dopo 16 settimane a metà del 2025, dati di mantenimento nel primo semestre del 2026 e dati della Parte B dopo 16 settimane nel secondo semestre del 2026. L'azienda prevede inoltre di avviare studi di Fase 1b sull'asma e uno studio combinato con APG990 nel 2025.
Apogee Therapeutics (NASDAQ: APGE) anunció avances significativos en su ensayo clínico de Fase 2 APEX sobre APG777 para la dermatitis atópica (AD) de moderada a severa. La compañía ha completado la inscripción de la Parte A anticipadamente con 123 pacientes, superando la meta de 110 pacientes, y ha comenzado a administrar dosis en la Parte B.
El ensayo evalúa APG777, un anticuerpo monoclonal subcutáneo de vida media prolongada que se dirige a IL-13. La Parte A randomizó a los pacientes en una proporción de 2:1 a APG777 frente a placebo, con los pacientes que recibieron 720mg en las semanas 0 y 2, seguidos de 360mg en las semanas 4 y 12. La Parte B implicará aproximadamente 280 pacientes randomizados 1:1:1:1 para recibir dosis alta, media o baja de APG777 frente a placebo.
Los próximos hitos importantes incluyen datos de 16 semanas de la Parte A a mediados de 2025, datos de mantenimiento en el primer semestre de 2026 y datos de 16 semanas de la Parte B en el segundo semestre de 2026. La compañía también planea iniciar ensayos de Fase 1b en asma y un estudio combinado con APG990 en 2025.
Apogee Therapeutics (NASDAQ: APGE)는 중증 아토피 피부염(AD) 치료를 위한 APG777의 2상 APEX 임상 시험에서 중요한 발전을 발표했습니다. 이 회사는 파트 A의 등록을 예정보다 빨리 완료하고 123명의 환자를 모집했습니다, 목표인 110명 환자를 초과했으며, 현재 파트 B에서 환자에게 약물을 투여하기 시작했습니다.
이번 시험은 IL-13을 표적으로 하는 새로운 피하 주사 제형의 반감기가 연장된 단일클론 항체인 APG777을 평가합니다. 파트 A에서는 환자들이 APG777과 위약에 2:1 비율로 무작위 배정되었으며, APG777 환자들은 0주와 2주에 720mg를 받은 후 4주와 12주에 360mg를 받게 됩니다. 파트 B는 약 280명의 환자가 APG777 고용량, 중용량 또는 저용량과 위약을 1:1:1:1 비율로 무작위 배정 받아 진행됩니다.
주요 예정된 이정표에는 2025년 중반에 파트 A의 16주 데이터가 포함됩니다, 2026년 상반기 유지 데이터, 2026년 하반기에 파트 B의 16주 데이터가 포함됩니다. 또한 이 회사는 2025년에 천식에 대한 1b 상 임상 시험을 시작하고 APG990와의 조합 연구를 계획하고 있습니다.
Apogee Therapeutics (NASDAQ: APGE) a annoncé des progrès significatifs dans son essai clinique de phase 2 APEX concernant APG777 pour la dermatite atopique (AD) modérée à sévère. L'entreprise a terminé l'inscription de la Partie A en avance avec 123 patients, dépassant l'objectif de 110 patients, et a commencé à administrer des doses aux patients dans la Partie B.
L'essai évalue APG777, un nouvel anticorps monoclonal sous-cutané à demi-vie prolongée ciblant l'IL-13. La Partie A a randomisé les patients dans un rapport de 2:1 entre APG777 et placebo, les patients recevant APG777 ayant reçu 720mg aux semaines 0 et 2, suivis de 360mg aux semaines 4 et 12. La Partie B impliquera environ 280 patients randomisés dans un rapport de 1:1:1:1 pour recevoir une dose haute, moyenne ou faible d'APG777 par rapport au placebo.
Les principales étapes à venir incluent les données de 16 semaines de la Partie A à la mi-2025, des données de maintien au premier semestre de 2026 et des données de 16 semaines de la Partie B au second semestre de 2026. L'entreprise prévoit également de commencer des essais de phase 1b sur l'asthme et une étude combinée avec APG990 en 2025.
Apogee Therapeutics (NASDAQ: APGE) hat bedeutende Fortschritte in seiner klinischen Studie der Phase 2 APEX zu APG777 für mittelschwere bis schwere atopische Dermatitis (AD) bekannt gegeben. Das Unternehmen hat die Einschreibung für Teil A vorzeitig mit 123 Patienten abgeschlossen und damit das Ziel von 110 Patienten übertroffen, und hat mit der Verabreichung der Behandlung in Teil B begonnen.
Die Studie bewertet APG777, einen neuartigen subkutanen monoklonalen Antikörper mit verlängerter Halbwertszeit, der auf IL-13 abzielt. In Teil A wurden die Patienten im Verhältnis 2:1 zu APG777 oder Placebo randomisiert, wobei die APG777-Patienten 720 mg in den Wochen 0 und 2 und danach 360 mg in den Wochen 4 und 12 erhielten. Teil B wird etwa 280 Patienten umfassen, die im Verhältnis 1:1:1:1 einer hohen, mittleren oder niedrigen Dosis von APG777 im Vergleich zu Placebo zugeteilt werden.
Wichtige bevorstehende Meilensteine umfassen Daten zu Teil A nach 16 Wochen Mitte 2025, Erhaltungsdaten im ersten Halbjahr 2026 und Daten zu Teil B nach 16 Wochen im zweiten Halbjahr 2026. Das Unternehmen plant außerdem, 2025 mit Phase 1b-Studien zu Asthma und einer kombinierten Studie mit APG990 zu beginnen.
- Exceeded enrollment target for Phase 2 Part A with 123 patients ahead of schedule
- APG777 designed to provide 70-90% fewer maintenance injections compared to current therapies
- Trial has greater than 90% power for the primary endpoint
- Multiple catalysts planned through 2026 including data readouts and expansion into new indications
- Primary efficacy data not available until mid-2025
- Requires successful completion of multiple clinical phases before potential commercialization
Insights
The acceleration of Apogee Therapeutics' Phase 2 APEX trial for APG777 represents a significant development in the $20+ billion atopic dermatitis market. The trial's innovative design, combining Phase 2a and 2b elements, could potentially reduce the development timeline by 6-12 months, providing a competitive advantage in the race to market.
Three key differentiators make this development particularly noteworthy:
- The trial's 90% statistical power for the primary endpoint, significantly exceeding the typical 80% threshold, provides robust confidence in the study's ability to detect treatment effects
- APG777's projected 30-40% higher exposure levels compared to lebrikizumab (Eli Lilly's approved AD treatment) suggests potential for superior efficacy
- The maintenance dosing schedule allowing for 3-6 month intervals represents a 70-90% reduction in injection frequency versus current therapies, potentially offering a significant competitive advantage in patient compliance and market share
The rapid progression from Part A to Part B within one week demonstrates strong operational execution and suggests high investigator confidence. The expansion strategy into asthma, EoE and combination therapies with APG990 indicates a well-planned pipeline development approach that could multiply the drug's market potential across multiple inflammatory conditions.
Multiple catalysts are approaching with data readouts scheduled throughout 2025-2026, including the important Part A 16-week data in mid-2025. The combination study versus DUPIXENT, the current market leader, could be particularly significant as it may establish APG777's competitive position in the market.
Enrollment of Part A completed ahead of schedule and exceeded enrollment target with 123 patients enrolled
Part A 16-week proof-of-concept data anticipated in mid-2025
SAN FRANCISCO and BOSTON, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis (EoE) and other I&I indications, today announced the first patient has been dosed in the Part B portion of the Phase 2 APEX clinical trial of APG777 in patients with moderate-to-severe AD, as well as enrollment completion in the Part A portion of the trial.
“Enrollment for the Phase 2 Part A trial of APG777 surpassed the approximately 110 patient target ahead of schedule, driven by strong patient and investigator enthusiasm, underscoring the potential of APG777 to address the need for safe, effective treatment options that reduce injection burden and provide better disease control for patients with AD and other I&I conditions,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “Positive results from our Phase 1 healthy volunteer trial enabled us to design this Phase 2 trial whereby APG777 is modeled to exceed lebrikizumab exposures by ~30
APEX is a Phase 2 randomized, placebo-controlled clinical trial evaluating APG777, a novel, subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD, in patients with moderate-to-severe AD. The trial was designed to combine the typical Phase 2a and 2b portions of a clinical trial into a single protocol. Part A exceeded expected enrollment with 123 patients randomized 2:1 to APG777 versus placebo; patients assigned to APG777 received induction regimen dosing of 720mg at weeks 0 and 2, followed by 360mg at weeks 4 and 12 and the trial has greater than
APG777 is currently in clinical development as a monotherapy for AD with several proof-of-concept anticipated readouts in 2025 and 2026, including Part A 16-week induction data in mid-2025 and maintenance data in the first half of 2026 as well as Part B 16-week data in the second half of 2026. Apogee plans to advance development of APG777 in expansion indications by initiating a Phase 1b trial in asthma in the first half of 2025, followed by a Phase 2b trial in asthma in the second half of 2025, and launching a Phase 2 trial in EoE in 2026. In addition, Apogee plans to evaluate APG777 in combination with other investigational therapies within Apogee’s pipeline to potentially enable greater efficacy and improved safety for I&I conditions. Apogee plans to initiate its first combination study, a Phase 1b trial of APG777 and APG990, a novel, SQ, half-life extended mAb targeting OX40L, in 2025. This combination study is designed to evaluate the safety, PK, PD and efficacy against DUPIXENT in patients with moderate-to-severe AD, with readout expected in the second half of 2026.
About APG777
APG777 is a novel, subcutaneous half-life extended monoclonal antibody targeting IL-13 for the potential treatment of AD. In head-to-head preclinical studies, APG777 showed equivalent or better potency to lebrikizumab in the inhibition of IL-13 signaling. APG777 Phase 1 trial data out to 12 months demonstrated a half-life of 77 days, a consistent safety and favorable PD profile showing near complete inhibition of pSTAT6 for up to 12 months after a single administration and sustained TARC inhibition. AD is a chronic inflammatory skin disorder with an estimated population of 82 million people worldwide afflicted with moderate-to-severe AD. Based on initial clinical data, the company plans to initiate a Phase 1b and 2b trial in asthma, a Phase 2 trial in EoE and plans to further evaluate opportunities to develop APG777 for other I&I indications, including alopecia areata, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and prurigo nodularis.
About Apogee
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, COPD, EoE 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 efficacy and dosing 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, particularly APG777; its plans for current and future clinical trials, including trial design and expected timing; expected timing for release of the initial Part A data from Apogee’s Phase 2 clinical trial of APG777 in AD; the potential clinical benefit, dosing schedule and half-life of APG777; plans for Apogee’s other product candidates, and any other potential programs, including combination therapies. 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, 2023, filed with the SEC on March 5, 2024, Quarterly Report on 10-Q for the quarterly period ended September 30, 2024, filed with the SEC on November 12, 2024, and subsequent disclosure documents we 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
dan@1abmedia.com
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