Acumen Pharmaceuticals Completes Enrollment of ALTITUDE-AD, a Phase 2 Clinical Trial of Sabirnetug (ACU193) in Early Alzheimer’s Disease
Acumen Pharmaceuticals (NASDAQ: ABOS) has completed enrollment ahead of schedule for its Phase 2 ALTITUDE-AD trial of sabirnetug (ACU193) in early Alzheimer's disease patients. The trial enrolled 542 patients across the US, Canada, EU, and UK.
The study will evaluate two dose levels (35mg/kg and 50mg/kg) administered every four weeks versus placebo. Topline results, including efficacy and safety data, are expected in late 2026. The primary endpoint is measuring change in the Integrated Alzheimer's Disease Rating Scale (iADRS) at 18 months.
Sabirnetug is the first humanized monoclonal antibody showing selective target engagement of amyloid beta oligomers (AβOs) in AD patients. The Phase 1 INTERCEPT-AD trial demonstrated the drug was generally well-tolerated with low ARIA-E rates, dose-dependent target engagement, and significant amyloid plaque reduction versus placebo at higher doses.
Acumen Pharmaceuticals (NASDAQ: ABOS) ha completato l'arruolamento in anticipo rispetto al programma per il suo trial di Fase 2 ALTITUDE-AD con sabirnetug (ACU193) in pazienti con Alzheimer precoce. Lo studio ha arruolato 542 pazienti negli Stati Uniti, Canada, UE e Regno Unito.
La ricerca valuterà due livelli di dosaggio (35mg/kg e 50mg/kg) somministrati ogni quattro settimane rispetto al placebo. I risultati preliminari, inclusi i dati di efficacia e sicurezza, sono attesi per la fine del 2026. L'obiettivo primario è misurare il cambiamento nella Scala di Valutazione Integrata della Malattia di Alzheimer (iADRS) a 18 mesi.
Sabirnetug è il primo anticorpo monoclonale umanizzato che mostra un'interazione selettiva con gli oligomeri di beta-amiloide (AβOs) nei pazienti con AD. Il trial di Fase 1 INTERCEPT-AD ha dimostrato che il farmaco è generalmente ben tollerato con basse percentuali di ARIA-E, un'interazione con il target dose-dipendente e una significativa riduzione delle placche amiloidi rispetto al placebo a dosi più elevate.
Acumen Pharmaceuticals (NASDAQ: ABOS) ha completado el reclutamiento antes de lo previsto para su ensayo de Fase 2 ALTITUDE-AD con sabirnetug (ACU193) en pacientes con Alzheimer temprano. El ensayo reclutó a 542 pacientes en EE. UU., Canadá, UE y Reino Unido.
El estudio evaluará dos niveles de dosis (35mg/kg y 50mg/kg) administrados cada cuatro semanas en comparación con un placebo. Se esperan resultados preliminares, incluidos datos de eficacia y seguridad, para finales de 2026. El objetivo principal es medir el cambio en la Escala de Evaluación Integrada de la Enfermedad de Alzheimer (iADRS) a los 18 meses.
Sabirnetug es el primer anticuerpo monoclonal humanizado que muestra un compromiso selectivo con los oligómeros de beta-amiloide (AβOs) en pacientes con AD. El ensayo de Fase 1 INTERCEPT-AD demostró que el fármaco fue generalmente bien tolerado con bajas tasas de ARIA-E, un compromiso con el objetivo dependiente de la dosis y una reducción significativa de las placas de amiloide en comparación con el placebo a dosis más altas.
Acumen Pharmaceuticals (NASDAQ: ABOS)는 초기 알츠하이머 환자를 대상으로 한 sabirnetug (ACU193)의 2상 ALTITUDE-AD 시험에서 예정보다 빠르게 등록을 완료했습니다. 이 시험은 미국, 캐나다, 유럽연합 및 영국에서 542명의 환자를 모집했습니다.
이 연구는 4주마다 투여되는 두 가지 용량 수준(35mg/kg 및 50mg/kg)을 평가하며, 위약과 비교합니다. 효능 및 안전성 데이터를 포함한 주요 결과는 2026년 말에 예상됩니다. 주요 목표는 18개월 후 통합 알츠하이머 질병 평가 척도(iADRS)의 변화를 측정하는 것입니다.
Sabirnetug는 알츠하이머 환자에서 아밀로이드 베타 올리고머(AβOs)에 대한 선택적 표적 결합을 보여주는 최초의 인간화된 단클론 항체입니다. 1상 INTERCEPT-AD 시험에서는 이 약물이 일반적으로 잘 견디며 ARIA-E 비율이 낮고, 용량 의존적인 표적 결합과 높은 용량에서 위약 대비 상당한 아밀로이드 플라크 감소를 보여주었습니다.
Acumen Pharmaceuticals (NASDAQ: ABOS) a terminé le recrutement en avance sur le calendrier pour son essai de Phase 2 ALTITUDE-AD avec sabirnetug (ACU193) chez des patients atteints de la maladie d'Alzheimer précoce. L'essai a recruté 542 patients aux États-Unis, au Canada, dans l'UE et au Royaume-Uni.
L'étude évaluera deux niveaux de dosage (35mg/kg et 50mg/kg) administrés toutes les quatre semaines par rapport à un placebo. Les résultats préliminaires, y compris les données d'efficacité et de sécurité, sont attendus pour fin 2026. L'objectif principal est de mesurer le changement dans l'Échelle d'Évaluation Intégrée de la Maladie d'Alzheimer (iADRS) à 18 mois.
Sabirnetug est le premier anticorps monoclonal humanisé montrant un engagement ciblé sélectif des oligomères de bêta-amyloïde (AβOs) chez les patients atteints de la MA. L'essai de Phase 1 INTERCEPT-AD a démontré que le médicament était généralement bien toléré avec de faibles taux d'ARIA-E, un engagement ciblé dépendant de la dose et une réduction significative des plaques amyloïdes par rapport au placebo à des doses plus élevées.
Acumen Pharmaceuticals (NASDAQ: ABOS) hat die Rekrutierung vorzeitig für seine Phase-2-Studie ALTITUDE-AD mit sabirnetug (ACU193) bei Patienten mit frühem Alzheimer abgeschlossen. In der Studie wurden 542 Patienten in den USA, Kanada, der EU und dem Vereinigten Königreich rekrutiert.
Die Studie wird zwei Dosierungsstufen (35mg/kg und 50mg/kg) untersuchen, die alle vier Wochen im Vergleich zu einem Placebo verabreicht werden. Die vorläufigen Ergebnisse, einschließlich der Wirksamkeits- und Sicherheitsdaten, werden Ende 2026 erwartet. Der primäre Endpunkt ist die Messung der Veränderung in der Integrierten Alzheimer-Krankheitsbewertungsskala (iADRS) nach 18 Monaten.
Sabirnetug ist der erste humanisierte monoklonale Antikörper, der eine selektive Zielbindung an Amyloid-Beta-Oligomere (AβOs) bei AD-Patienten zeigt. Die Phase-1-Studie INTERCEPT-AD zeigte, dass das Medikament im Allgemeinen gut vertragen wurde, mit niedrigen ARIA-E-Raten, einer dosisabhängigen Zielbindung und einer signifikanten Reduktion der Amyloid-Plaques im Vergleich zum Placebo bei höheren Dosen.
- Early completion of Phase 2 trial enrollment ahead of schedule
- Large trial size with 542 patients enrolled
- Positive Phase 1 results showing good tolerability and efficacy
- First antibody demonstrating selective AβO target engagement in AD patients
- Significant amyloid plaque reduction shown in Phase 1 at higher doses
- Long wait for topline results (late 2026)
- Competitive market with multiple established Alzheimer's treatments
Insights
Acumen Pharmaceuticals' completion of enrollment in its Phase 2 ALTITUDE-AD trial ahead of schedule represents a significant operational milestone in the development of sabirnetug. The accelerated enrollment pace suggests strong interest from the clinical community in this novel approach targeting soluble amyloid beta oligomers (AβOs).
What differentiates sabirnetug in the crowded Alzheimer's therapeutic landscape is its selective targeting of AβOs, which are considered particularly toxic contributors to synaptic dysfunction and neurodegeneration. This specificity potentially offers a more precise intervention compared to broader amyloid-targeting approaches.
The previously reported Phase 1 data demonstrated two critical advantages: dose-dependent target engagement and low rates of ARIA-E (amyloid-related imaging abnormalities with edema) – a safety concern that has complicated the clinical profile of several competing amyloid-targeting therapies.
The robust trial design with 542 patients across multiple regions and the comprehensive endpoint selection (iADRS primary with CDR-SB and ADAS-Cog13 secondary measures) positions this study to provide definitive answers about sabirnetug's efficacy profile when results arrive in late 2026.
For a company with Acumen's market capitalization (
NEWTON, Mass., March 26, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced the completion of enrollment in its ALTITUDE-AD Phase 2 trial of sabirnetug (ACU193) in patients with early Alzheimer’s disease. Acumen completed enrollment ahead of schedule and plans to report topline results, including efficacy and safety data, in late 2026.
"We are pleased to complete enrollment for our Phase 2 ALTITUDE-AD trial of sabirnetug," said Daniel O’Connell, President and Chief Executive Officer of Acumen. "Achieving this milestone is a testament to the significant interest in our approach from both patients and the scientific community, and we are grateful to all the participants, investigators and trial sites, and our clinical team for enabling us to complete enrollment efficiently. We look forward to sharing topline results in late 2026 and advancing sabirnetug as a next-generation treatment for Alzheimer’s disease."
Sabirnetug is the first humanized monoclonal antibody to demonstrate in AD patients selective target engagement of AβOs, a soluble and highly toxic form of Aβ that accumulates early in AD and is a persistent trigger of synaptic dysfunction and neurodegeneration. The Phase 1 INTERCEPT-AD clinical trial demonstrated sabirnetug was generally well-tolerated with low overall rates of ARIA-E. The trial also showed dose- and exposure-dependent target engagement and statistically significant amyloid plaque reduction compared to placebo at higher dose multiple-ascending dose cohorts evaluated in the study.
ALTITUDE-AD (NCT06335173) is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial that enrolled 542 patients with early AD at sites in the United States, Canada, the European Union and the United Kingdom. The study participants were randomized to receive one of two dose levels of sabirnetug (35mg/kg or 50mg/kg once every four weeks) or placebo. The primary endpoint is change from baseline in the Integrated Alzheimer’s Disease Rating Scale (iADRS) at 18 months. Secondary endpoints include the Clinical Dementia Rating – Sum of Boxes scale (CDR-SB), ADAS-Cog13, ADCS-ADL and various AD biomarkers. Standard safety measures and MRIs will also be assessed. Participants who completed the double-blind portion of the study will have the opportunity to continue into an open-label extension.
About Sabirnetug (ACU193)
Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble amyloid beta oligomers (AβOs), which are a highly toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AβOs, sabirnetug aims to address the hypothesis that soluble AβOs are an early and persistent underlying cause of the neurodegenerative process in Alzheimer’s disease (AD). Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration and is currently being evaluated in a Phase 2 study in patients with early AD.
About ALTITUDE-AD (Phase 2)
Initiated in 2024, ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug (ACU193) infusions administered once every four weeks in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease. The study has enrolled approximately 540 individuals with early Alzheimer’s disease (mild cognitive impairment or mild dementia due to AD) at multiple investigative sites located in the United States, Canada, the European Union and the United Kingdom. More information can be found on www.clinicaltrials.gov, NCT identifier NCT06335173.
About Acumen Pharmaceuticals, Inc.
Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs, in its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in early symptomatic Alzheimer’s disease patients, following positive results in its Phase 1 trial INTERCEPT-AD. The company is headquartered in Newton, Mass. For more information, visit www.acumenpharm.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “potential,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning the therapeutic potential and potential clinical efficacy of Acumen’s product candidate, sabirnetug (ACU193), and the timing of topline results for the ALTITUDE-AD trial. These statements are based upon the current beliefs and expectations of Acumen’s management, and are subject to certain factors, risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics. Such risks may be amplified by the impacts of geopolitical events and macroeconomic conditions, such as rising inflation and interest rates, supply disruptions and uncertainty of credit and financial markets. These and other risks concerning Acumen’s programs are described in additional detail in Acumen’s filings with the Securities and Exchange Commission (“SEC”), including in Acumen’s most recent Annual Report on Form 10-K, and in subsequent filings with the SEC. Copies of these and other documents are available from Acumen. Additional information will be made available in other filings that Acumen makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Acumen expressly disclaims any obligation to update or revise any forward-looking statement, except as otherwise required by law, whether, as a result of new information, future events or otherwise.
Investors:
Alex Braun
abraun@acumenpharm.com
Media:
Jon Yu
ICR Healthcare
AcumenPR@icrhealthcare.com
FAQ
When will Acumen Pharmaceuticals (ABOS) report topline results for the ALTITUDE-AD Phase 2 trial?
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