Apogee Therapeutics Announces First Participants Dosed in Phase 1 Clinical Trial of APG333, its Novel Half-Life Extended TSLP Antibody for the Treatment of Respiratory and Broader I&I Conditions
Apogee Therapeutics (APGE) has initiated dosing in its Phase 1 clinical trial of APG333, a novel subcutaneous half-life extended monoclonal antibody targeting TSLP for respiratory and inflammatory conditions. The trial marks the company's fourth clinical program in under 18 months.
The Phase 1 trial is designed as a double-blind, placebo-controlled study in healthy volunteers, evaluating safety, tolerability, and pharmacokinetics. The study will enroll approximately 32 healthy adults across 4 cohorts, with interim data expected in second half of 2025.
The company plans to explore APG333 initially for asthma treatment, with potential combination therapy with APG777. Preclinical studies of the APG777 + APG333 combination have shown promising results in inhibiting inflammation with potential for less frequent dosing.
Apogee Therapeutics (APGE) ha avviato la somministrazione nel suo trial clinico di Fase 1 per APG333, un nuovo anticorpo monoclonale sottocutaneo a emivita prolungata che mira al TSLP per condizioni respiratorie e infiammatorie. Lo studio segna il quarto programma clinico dell'azienda in meno di 18 mesi.
Il trial di Fase 1 è progettato come uno studio in doppio cieco, controllato con placebo, su volontari sani, per valutare sicurezza, tollerabilità e farmacocinetica. Lo studio arruolerà circa 32 adulti sani suddivisi in 4 coorti, con dati intermedi attesi nella seconda metà del 2025.
L'azienda prevede di esplorare inizialmente APG333 per il trattamento dell'asma, con la possibilità di una terapia combinata con APG777. Studi preclinici della combinazione APG777 + APG333 hanno mostrato risultati promettenti nell'inibizione dell'infiammazione, con un potenziale per dosaggi meno frequenti.
Apogee Therapeutics (APGE) ha iniciado la dosificación en su ensayo clínico de Fase 1 de APG333, un novedoso anticuerpo monoclonal subcutáneo de vida media prolongada que se dirige al TSLP para condiciones respiratorias e inflamatorias. El ensayo marca el cuarto programa clínico de la compañía en menos de 18 meses.
El ensayo de Fase 1 está diseñado como un estudio doble ciego, controlado con placebo, en voluntarios sanos, evaluando seguridad, tolerabilidad y farmacocinética. El estudio inscribirá aproximadamente a 32 adultos sanos en 4 cohortes, con datos provisionales previstos para la segunda mitad de 2025.
La compañía planea explorar inicialmente APG333 para el tratamiento del asma, con una potencial terapia combinada con APG777. Los estudios preclínicos de la combinación APG777 + APG333 han mostrado resultados prometedores en la inhibición de la inflamación, con potencial para dosis menos frecuentes.
Apogee Therapeutics (APGE)는 호흡기 및 염증 질환을 대상으로 하는 TSLP를 겨냥한 새로운 피하 반감기 연장 단일 클론 항체 APG333의 1상 임상 시험에서 투약을 시작했습니다. 이 시험은 18개월 이내에 회사의 네 번째 임상 프로그램을 의미합니다.
1상 시험은 건강한 자원봉사자를 대상으로 하며, 안전성, 내약성 및 약물 동태를 평가하는 이중 맹검, 위약 대조 연구로 설계되었습니다. 연구에는 약 32명의 건강한 성인이 4개의 집단으로 등록되며, 중간 데이터는 2025년 하반기로 예상됩니다.
회사는 초기에는 APG333를 천식 치료에 탐색할 계획이며, APG777과의 조합 요법 가능성도 고려하고 있습니다. APG777 + APG333 조합에 대한 전임상 연구는 염증 억제에서 유망한 결과를 보여주었으며, 덜 빈번한 투여 가능성을 가지고 있습니다.
Apogee Therapeutics (APGE) a lancé l'administration dans son essai clinique de Phase 1 pour APG333, un nouvel anticorps monoclonal sous-cutané à demi-vie prolongée ciblant le TSLP pour des conditions respiratoires et inflammatoires. Cet essai marque le quatrième programme clinique de l'entreprise en moins de 18 mois.
L'essai de Phase 1 est conçu comme une étude en double aveugle, contrôlée par placebo, chez des volontaires sains, évaluant la sécurité, la tolérance et la pharmacocinétique. L'étude inscrira environ 32 adultes en bonne santé répartis en 4 cohortes, avec des données intermédiaires attendues dans la seconde moitié de 2025.
L'entreprise prévoit d'explorer APG333 en premier lieu pour le traitement de l'asthme, avec un potentiel de thérapie combinée avec APG777. Des études précliniques de la combinaison APG777 + APG333 ont montré des résultats prometteurs dans l'inhibition de l'inflammation, avec un potentiel pour des doses moins fréquentes.
Apogee Therapeutics (APGE) hat mit der Verabreichung in seiner Phase-1-Studie zu APG333 begonnen, einem neuartigen subkutanen, mit einer verlängerten Halbwertszeit ausgestatteten monoklonalen Antikörper, der auf TSLP abzielt und bei Atemwegs- und entzündlichen Erkrankungen eingesetzt wird. Die Studie markiert das vierte klinische Programm des Unternehmens in weniger als 18 Monaten.
Die Phase-1-Studie ist als doppelblindes, placebo-kontrolliertes Studium an gesunden Freiwilligen konzipiert, um Sicherheit, Verträglichkeit und Pharmakokinetik zu bewerten. Es werden etwa 32 gesunde Erwachsene in 4 Kohorten eingeschlossen, mit Zwischenberichten, die in der zweiten Jahreshälfte 2025 erwartet werden.
Das Unternehmen plant, APG333 zunächst zur Behandlung von Asthma zu erforschen, möglicherweise in Kombination mit APG777. Präklinische Studien zur Kombination von APG777 + APG333 haben vielversprechende Ergebnisse bei der Hemmung von Entzündungen gezeigt, mit dem Potenzial für weniger häufige Dosen.
- Fourth clinical program initiated in less than 18 months, showing rapid pipeline expansion
- Preclinical studies demonstrate potential superior efficacy of APG777 + APG333 combination
- Targeting both Type 2 and Type 3 inflammation pathways, addressing broader patient population
- Interim data not expected until second half of 2025
- Early-stage development (Phase 1) with significant time to potential commercialization
Insights
Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2H 2025
APG777 + APG333 can potentially address key drivers of respiratory diseases more broadly versus monotherapy
Preclinical proof-of-concept achieved for APG777 + APG333 combination with clinical trial planning underway in asthma and COPD
SAN FRANCISCO and WALTHAM, Mass., Dec. 10, 2024 (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 that it has initiated dosing of healthy volunteers in its clinical trial of APG333, a novel, subcutaneous (SQ) half-life extended monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which is being evaluated initially as a treatment for people living with asthma, COPD and broader I&I conditions.
“The initiation of the APG333 Phase 1 clinical trial marks our fourth program to enter clinical trials in less than 18 months and represents an important step in our pipeline evolution, as we continue to establish the building blocks for our combination strategy,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “TSLP is a clinically validated target that plays an important role in both Type 2 and Type 3 inflammation, the primary drivers of inflammatory respiratory conditions. Based on its mechanism, it has the potential to broadly address obstructive respiratory diseases, including for the approximately half of patients with low Type 2 inflammatory respiratory diseases who currently have fewer treatment options. We plan to initially explore APG333 for the treatment of asthma, with the ultimate goal of leveraging this investigational therapy in combination with APG777, a combination approach that could optimally address respiratory and broader I&I diseases.”
The APG333 Phase 1 clinical trial is designed as a double-blind, placebo controlled, first-in-human, single-ascending dose trial in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics (PK) of APG333 and is expected to enroll approximately 32 healthy adults into 4 cohorts. Apogee expects interim data from the trial in the second half of 2025.
In preclinical studies, the combination of APG777 + APG333 has been shown to drive broader and deeper inhibition of inflammation centrally with deeper impact on local airway responses compared to approved or in-development biologics, with the potential for a significantly less frequent dosing schedule.
About APG333
APG333 is a novel, SQ extended half-life mAb targeting TSLP, a key driver of Type 2 and Type 3 inflammation in eosinophilic and non-eosinophilic conditions. TSLP is an epithelial cell-derived cytokine that has emerged as an attractive validated target for the treatment of I&I indications. In addition, a TSLP-targeting mAb may be used in combination with other mAbs for potentially greater efficacy in broader populations. TSLP inhibition has been clinically validated, with one approved product on the market for the treatment of severe asthma without biomarker or phenotype restrictions.
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, its plans for current and future clinical trials, including a Phase 1 clinical trial for APG333; Apogee’s plans for clinical trial design; the anticipated timing of the initiation of and results from Apogee’s clinical trials, including data from Apogee’s Phase 1 clinical trial of APG333; and the potential clinical benefit and half-life of APG333 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
FAQ
What is the purpose of Apogee Therapeutics' (APGE) Phase 1 trial for APG333?
How many participants will be enrolled in APGE's APG333 Phase 1 trial?
When will Apogee Therapeutics (APGE) release interim data for the APG333 trial?
What conditions does Apogee Therapeutics (APGE) plan to target with APG333?
