Acumen Pharmaceuticals Presents Innovative Trial Screening Advancements Utilizing pTau217 Assay in Phase 2 Study of Sabirnetug for Early Alzheimer’s Disease at the 17th Annual Clinical Trials on Alzheimer’s Disease Conference
Acumen Pharmaceuticals presented data on using pTau217 assay as an efficient screening tool for their Phase 2 ALTITUDE-AD clinical trial of sabirnetug for early Alzheimer's disease. The assay, with a threshold of ≥0.15 pg/mL, effectively identifies potential participants likely to have amyloid in the brain, reducing unnecessary amyloid PET scans and lumbar procedures. 74% of participants with elevated pTau217 met amyloid burden eligibility requirements, compared to 40% in their Phase 1 trial without this screening approach. The study is enrolling at 75 sites across multiple regions, with completion expected in first half of 2025.
Acumen Pharmaceuticals ha presentato dati sull'utilizzo del saggio pTau217 come strumento di screening efficiente per il loro studio clinico di Fase 2 ALTITUDE-AD riguardante il sabirnetug per la malattia di Alzheimer nella sua fase iniziale. Il saggio, con una soglia di ≥0,15 pg/mL, identifica in modo efficace i potenziali partecipanti che potrebbero avere amiloide nel cervello, riducendo così le scansioni PET per amiloide e le procedure lombari non necessarie. Il 74% dei partecipanti con pTau217 elevato ha soddisfatto i requisiti di idoneità per il carico di amiloide, rispetto al 40% nel loro studio di Fase 1 senza questo approccio di screening. Lo studio sta reclutando presso 75 centri in diverse regioni, con completamento previsto nella prima metà del 2025.
Acumen Pharmaceuticals presentó datos sobre el uso del ensayo pTau217 como una herramienta de detección eficiente para su ensayo clínico de Fase 2 ALTITUDE-AD de sabirnetug para la enfermedad de Alzheimer en etapas tempranas. El ensayo, con un umbral de ≥0,15 pg/mL, identifica de manera efectiva a los posibles participantes que probablemente tengan amiloide en el cerebro, reduciendo así las exploraciones PET de amiloide y los procedimientos lumbares innecesarios. El 74% de los participantes con pTau217 elevado cumplió con los requisitos de elegibilidad para la carga de amiloide, en comparación con el 40% en su ensayo de Fase 1 sin este enfoque de detección. El estudio está reclutando en 75 sitios en diversas regiones, con finalización prevista para la primera mitad de 2025.
Acumen Pharmaceuticals는 초기 알츠하이머병을 위한 사비르네투그의 2상 ALTITUDE-AD 임상 시험에서 pTau217 분석을 효율적인 선별 도구로 사용하는 데이터 발표했습니다. 이 분석은 ≥0.15 pg/mL 의 기준으로 뇌에서 아밀로이드가 있을 가능성이 있는 참가자를 효과적으로 식별하여 불필요한 아밀로이드 PET 스캔 및 요추 절차를 줄입니다. pTau217 수치가 높은 참가자의 74%가 아밀로이드 부담 적격 요건을 충족했으며, 이는 이 선별 접근 방식 없이 진행된 1상 시험의 40%와 비교됩니다. 이 연구는 여러 지역에서 75개의 사이트에서 모집 중이며, 2025년 상반기 내 완료가 예상됩니다.
Acumen Pharmaceuticals a présenté des données sur l'utilisation du test pTau217 en tant qu'outil de dépistage efficace pour leur essai clinique de Phase 2 ALTITUDE-AD concernant le sabirnetug pour la maladie d'Alzheimer précoce. Le test, avec un seuil de ≥0,15 pg/mL, identifie efficacement les participants potentiels susceptibles d'avoir de l'amyloïde dans le cerveau, réduisant ainsi le besoin de scans PET pour l'amyloïde et de procédures lombaires inutiles. 74 % des participants ayant des niveaux élevés de pTau217 ont satisfait aux critères d'éligibilité pour la charge amyloïde, contre 40 % lors de leur essai de Phase 1 sans cette approche de dépistage. L'étude recrute dans 75 sites répartis dans plusieurs régions, avec une conclusion attendue au cours de la première moitié de 2025.
Acumen Pharmaceuticals hat Daten zur Verwendung des pTau217-Assays als effizientes Screening-Tool für ihre Phase-2-Studie ALTITUDE-AD zu Sabirnetug bei früher Alzheimer-Krankheit präsentiert. Der Assay mit einer Schwelle von ≥0,15 pg/mL identifiziert effektiv potenzielle Teilnehmer, die wahrscheinlich Amyloid im Gehirn haben, und reduziert unnötige Amyloid-PET-Scans sowie Lumbalverfahren. 74% der Teilnehmer mit erhöhtem pTau217 erfüllten die Eignungskriterien für die Amyloidlast, verglichen mit 40% in ihrer Phase-1-Studie ohne diesen Screening-Ansatz. Die Studie wird an 75 Standorten in mehreren Regionen durchgeführt, mit einem Abschluss, der in der ersten Hälfte des Jahres 2025 erwartet wird.
- 74% success rate in identifying eligible participants using pTau217 screening, up from 40% in Phase 1
- Study enrollment progressing well across 75 sites internationally
- Implementation of more efficient and less invasive screening process
- More than 50% of potential participants excluded due to low pTau217 levels
- Study completion not expected until first half of 2025
Insights
The implementation of pTau217 assay as a screening tool in ALTITUDE-AD represents a significant advancement in clinical trial methodology for Alzheimer's research. The 74% success rate in identifying eligible participants, compared to just 40% in the previous Phase 1 trial, demonstrates substantial improvement in screening efficiency. This innovation reduces trial costs and accelerates enrollment, potentially shortening the overall development timeline for sabirnetug.
The screening threshold of >0.15 pg/mL for pTau217 is proving effective at enriching the trial population, with over half of potential participants being excluded early in the process. This approach not only streamlines the trial but also minimizes unnecessary invasive procedures. With 75 sites across multiple regions and enrollment completion expected in H1 2025, the trial's progress suggests strong operational execution and investigator interest in this novel AβO-targeting approach.
- Late-breaking presentation highlights the pTau217 assay as an effective and efficient tool to screen participants for ALTITUDE-AD that reduces unnecessary amyloid PET scans and lumbar puncture procedures for those who are not eligible
NEWTON, Mass., Oct. 31, 2024 (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 presented updated data on a validated research-use plasma pTau217 assay to screen potential participants in the ongoing Phase 2 ALTITUDE-AD clinical trial of sabirnetug, at the 17th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference. The study found that this enrichment screening approach is resulting in a higher proportion of participants who meet the amyloid PET or CSF-based inclusion criteria compared to Acumen’s Phase 1 INTERCEPT-AD trial, which did not use this approach. Furthermore, the enrichment approach is resulting in a more efficient participant selection process that reduces unnecessary amyloid PET scans or lumbar puncture (LP) procedures among people who are not eligible to continue in screening.
“The pTau217 screening assay enrichment approach is an important part of the clinical trial process for Alzheimer’s treatments because it could spare patients from invasive lumbar punctures and unnecessary radiation exposure with an amyloid PET scan,” said Todd Feaster, Psy.D., Senior Clinical Research Scientist at Acumen Pharmaceuticals and the study presenter. “We are encouraged to see that our screening strategy is performing as intended and streamlining the trial enrollment process overall. Screening assays like this can reduce burden for patients, clinical trial investigators and their staff and foster a more compassionate and sustainable clinical trial experience.”
ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug. The study drug will be evaluated in approximately 540 adults ages 50 to 90 years. Thus far, the study is enrolling at 75 sites across the U.S., Canada, EU and U.K. Acumen expects to complete enrollment in the first half of 2025.
One key eligibility criterion in ALTITUDE-AD and other clinical trials for amyloid-targeting therapies is the confirmation of cerebral amyloid accumulation by either PET scan or CSF, which can be more burdensome and time-intensive than a blood biomarker assay. However, plasma concentrations of the biomarker pTau217 are a strong indicator of AD pathology. While not a diagnostic, the pTau217 assay is being used at U.S. trial sites as an enrichment approach – a first step to help identify potential clinical trial participants with the highest likelihood of having amyloid in the brain as confirmed by a subsequent PET scan or CSF.
The pTau217 assay is an effective tool for classifying participants most likely to be eligible for the ALTITUDE-AD study. The study established a pTau217 threshold of ≥0.15 pg/mL, which was designed for enrichment purposes in this study of early AD and was not intended as a diagnostic cut-point. To date, more than half of potential ALTITUDE-AD study participants have been excluded from the study because of a plasma p-tau217 test result <0.15 pg/mL. Overall,
“The study is not only a testament to our commitment to advancing a next-generation treatment for Alzheimer’s disease but also our commitment to pioneering clinical trial designs that provide an improved patient experience,” said Daniel O’Connell, President and Chief Executive Officer of Acumen. “We are pleased with the pace of enrollment in ALTITUDE-AD thus far. This swift progress underscores the strong interest in our approach and desire to bring more innovative solutions to those affected by Alzheimer’s.”
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 will enroll approximately 540 individuals with early Alzheimer’s disease (mild cognitive impairment or mild dementia due to AD). The global study is currently ongoing at multiple investigative sites located in the United States, Canada, the United Kingdom, and the European Union. 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 effectiveness of the pTau217 assay, the therapeutic potential and potential clinical efficacy of Acumen’s product candidate, sabirnetug (ACU193), and enrollment in the Phase 2 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.
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FAQ
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