Acumen Pharmaceuticals Announces Journal of Prevention of Alzheimer’s Disease Publication of the Company’s Phase 1 INTERCEPT-AD Study, Including Target Engagement, Dosing Regimen and Safety Findings
Acumen Pharmaceuticals (NASDAQ: ABOS) announced the publication of Phase 1 INTERCEPT-AD clinical trial results for sabirnetug (ACU193) in the Journal of Prevention of Alzheimer's Disease. The study, involving 65 early Alzheimer's disease patients, demonstrated that sabirnetug was generally well-tolerated with dose-dependent target engagement of amyloid beta oligomers (AβOs) and significant amyloid plaque reduction in higher dose cohorts.
Key findings include selective AβO target engagement, low overall levels of ARIA-E, and only one participant experiencing mild ARIA-E that resolved within four weeks. The company is currently conducting the Phase 2 ALTITUDE-AD trial, which began in May 2024 and aims to enroll approximately 540 adults across 75 sites in the U.S., Canada, EU, and U.K. Enrollment completion is expected in the first half of 2025.
Acumen Pharmaceuticals (NASDAQ: ABOS) ha annunciato la pubblicazione dei risultati del trial clinico di Fase 1 INTERCEPT-AD per sabirnetug (ACU193) sulla rivista Journal of Prevention of Alzheimer's Disease. Lo studio, che ha coinvolto 65 pazienti con Alzheimer in fase iniziale, ha dimostrato che il sabirnetug è stato generalmente ben tollerato, con un coinvolgimento dei bersagli degli oligomeri di beta-amiloide (AβOs) dipendente dalla dose e una significativa riduzione delle placche amiloidi nei gruppi a dosaggio più elevato.
I risultati chiave includono un coinvolgimento selettivo del bersaglio AβO, bassi livelli complessivi di ARIA-E e solo un partecipante ha sperimentato un lieve ARIA-E che si è risolto entro quattro settimane. La società sta attualmente conducendo il trial di Fase 2 ALTITUDE-AD, iniziato a maggio 2024, che mira a reclutare circa 540 adulti in 75 siti negli Stati Uniti, Canada, UE e Regno Unito. Il completamento del reclutamento è previsto per la prima metà del 2025.
Acumen Pharmaceuticals (NASDAQ: ABOS) anunció la publicación de los resultados del ensayo clínico de Fase 1 INTERCEPT-AD para sabirnetug (ACU193) en el Journal of Prevention of Alzheimer's Disease. El estudio, que involucró a 65 pacientes con enfermedad de Alzheimer en estadios tempranos, demostró que el sabirnetug fue generalmente bien tolerado, con un compromiso del objetivo de oligómeros de beta-amiloide (AβOs) dependiente de la dosis y una reducción significativa de las placas amiloides en los grupos de dosis más alta.
Los hallazgos clave incluyen un compromiso selectivo del objetivo AβO, bajos niveles generales de ARIA-E y solo un participante experimentó un leve ARIA-E que se resolvió en cuatro semanas. La empresa está llevando a cabo actualmente el ensayo de Fase 2 ALTITUDE-AD, que comenzó en mayo de 2024 y tiene como objetivo inscribir aproximadamente a 540 adultos en 75 sitios en EE. UU., Canadá, UE y Reino Unido. Se espera que la finalización del reclutamiento ocurra en la primera mitad de 2025.
Acumen Pharmaceuticals (NASDAQ: ABOS)은 sabirnetug (ACU193)에 대한 1상 INTERCEPT-AD 임상 시험 결과를 알츠하이머병 예방 저널에 발표했다고 전했습니다. 이 연구는 초기 알츠하이머병 환자 65명을 포함하였으며, sabirnetug이 일반적으로 잘 견딜 수 있었고, 용량 의존적인 아밀로이드 베타 올리고머(AβOs) 타겟 참여와 높은 용량 그룹에서의 상당한 아밀로이드 플라크 감소가 있었음을 보여주었습니다.
주요 발견 사항으로는 선택적인 AβO 타겟 참여, 낮은 전반적인 ARIA-E 수준, 그리고 단 한 명의 참가자만이 4주 이내에 해결된 경미한 ARIA-E를 경험한 점이 포함됩니다. 현재 회사는 2024년 5월에 시작된 2상 ALTITUDE-AD 시험을 진행 중이며, 미국, 캐나다, EU 및 영국의 75개 사이트에서 약 540명의 성인을 등록할 예정입니다. 등록 완료는 2025년 상반기 내에 이루어질 것으로 예상됩니다.
Acumen Pharmaceuticals (NASDAQ: ABOS) a annoncé la publication des résultats de l'essai clinique de phase 1 INTERCEPT-AD pour sabirnetug (ACU193) dans le Journal of Prevention of Alzheimer's Disease. L'étude, impliquant 65 patients atteints de la maladie d'Alzheimer à un stade précoce, a démontré que le sabirnetug était généralement bien toléré, avec un engagement ciblé des oligomères de bêta-amyloïde (AβOs) dépendant de la dose et une réduction significative des plaques amyloïdes dans les groupes de dose plus élevée.
Les résultats clés incluent un engagement sélectif des cibles AβO, des niveaux globaux d'ARIA-E faibles et un seul participant ayant éprouvé un ARIA-E léger qui a été résolu en quatre semaines. L'entreprise mène actuellement l'essai de phase 2 ALTITUDE-AD, qui a débuté en mai 2024 et vise à recruter environ 540 adultes dans 75 sites aux États-Unis, au Canada, dans l'UE et au Royaume-Uni. La conclusion des recrutements est attendue dans la première moitié de 2025.
Acumen Pharmaceuticals (NASDAQ: ABOS) hat die Veröffentlichung der Ergebnisse der Phase 1 INTERCEPT-AD-Studie für sabirnetug (ACU193) im Journal of Prevention of Alzheimer's Disease bekannt gegeben. Die Studie, die 65 Patienten mit früh einsetzender Alzheimer-Krankheit einbezieht, hat gezeigt, dass sabirnetug im Allgemeinen gut vertragen wurde, mit dosierungsabhängiger Zielverbindung von Amyloid-Beta-Oligomeren (AβOs) und einer signifikanten Reduktion der Amyloid-Plaques in den höheren Dosierungsgruppen.
Wichtige Ergebnisse umfassen eine selektive AβO-Zielverbindung, niedrige Gesamtwerte von ARIA-E und nur ein Teilnehmer erlebte eine milde ARIA-E, die innerhalb von vier Wochen abgeklungen ist. Das Unternehmen führt derzeit die Phase-2-Studie ALTITUDE-AD durch, die im Mai 2024 begonnen hat und die etwa 540 Erwachsene an 75 Standorten in den USA, Kanada, der EU und dem Vereinigten Königreich rekrutieren soll. Der Abschluss der Rekrutierung wird für die erste Hälfte des Jahres 2025 erwartet.
- Successful Phase 1 trial results showing selective target engagement
- Low incidence of adverse effects (ARIA-E)
- Phase 2 trial actively enrolling at 75 sites globally
- Demonstrated statistically significant amyloid plaque reduction in higher dose cohorts
- None.
Insights
The Phase 1 INTERCEPT-AD trial results for sabirnetug represent a notable advancement in Alzheimer's disease treatment development. The data reveals selective targeting of amyloid beta oligomers (AβOs) with dose-dependent efficacy and a favorable safety profile, particularly regarding ARIA-E incidence. The low ARIA-E rates, especially in high-risk APOE4 homozygotes, differentiate sabirnetug from existing amyloid-targeting therapies.
The ongoing Phase 2 ALTITUDE-AD trial, targeting 540 patients across multiple regions, builds upon these promising results. The trial's robust design and international scope enhance the potential for meaningful efficacy data. The anticipated enrollment completion in 1H 2025 positions the company for significant clinical milestones in the near term.
For context, successful Alzheimer's treatments typically command substantial market value, with recent approvals achieving multi-billion dollar valuations. Given Acumen's
The publication in a peer-reviewed journal validates sabirnetug's novel mechanism targeting toxic soluble AβOs, a differentiator from current market treatments. The Phase 1 data, particularly the favorable safety profile and target engagement metrics, substantially de-risks the ongoing Phase 2 trial.
With 75 active trial sites and enrollment progressing, the company appears well-positioned to meet its 1H 2025 enrollment completion target. The current
Key catalysts include interim Phase 2 data readouts and potential partnership discussions, as larger pharmaceutical companies typically seek to acquire promising AD assets with differentiated mechanisms and strong safety profiles. The company's focused pipeline and clear development pathway make it an attractive candidate for strategic transactions.
Phase 1 INTERCEPT-AD data published in Journal of Prevention of Alzheimer’s Disease supports continued development of sabirnetug (ACU193) for treatment of early Alzheimer’s disease (AD)
Sabirnetug demonstrated selective, dose-dependent target engagement of amyloid beta oligomers (AβOs), statistically significant amyloid plaque reduction within higher dose cohorts, and low overall levels of ARIA-E
Phase 2 ALTITUDE-AD clinical trial of sabirnetug is ongoing with enrollment completion expected 1H 2025
NEWTON, Mass., Jan. 09, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), 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), today announced that the Journal of Prevention of Alzheimer’s Disease published the results of the Phase 1 INTERCEPT-AD clinical trial demonstrating that sabirnetug (ACU193) was generally well-tolerated with dose- and exposure-dependent target engagement and reduction in amyloid plaques.
Acumen is developing sabirnetug as a potential next-generation antibody treatment for early symptomatic AD. Sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AβOs in patients with early symptomatic AD. Soluble AβOs are a highly toxic form of Aβ that begin to accumulate before a clinical diagnosis of symptomatic AD and are an early and persistent trigger of synaptic dysfunction and neurodegeneration.
“The robust data package generated by this Phase 1 study provides important evidence of sabirnetug’s safety profile, further confirms the mechanism of action of sabirnetug and establishes the foundation for our ongoing Phase 2 ALTITUDE-AD clinical trial, including the doses used in ALTITUDE-AD,” said Eric Siemers, M.D., Chief Medical Officer of Acumen. “We are pleased to highlight the strength of our study design and the creation of advanced tools for drug development, including an assay that can detect very small amounts of sabirnetug bound to toxic soluble amyloid beta oligomers in human cerebrospinal fluid.”
INTERCEPT-AD was a randomized, double-blind, placebo-controlled Phase 1 clinical trial designed to evaluate the safety and tolerability of sabirnetug in patients with early AD. A total of 65 individuals with early AD (mild cognitive impairment or mild dementia due to AD) enrolled in this first-in-humans study of sabirnetug. The results, which were previously presented at scientific congresses, demonstrated selective target engagement of AβOs in a dose-dependent and exposure-dependent manner, statistically significant amyloid plaque reduction within higher dose multiple-ascending dose cohorts, and low overall levels of amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) or hemorrhage/hemosiderin deposition (ARIA-H). One participant experienced mildly symptomatic ARIA-E, which resolved within four weeks. None of the six participants who were apolipoprotein E Ɛ4 homozygotes and received sabirnetug developed ARIA-E or ARIA-H.
“The publication of this data in the Journal of Prevention of Alzheimer’s Disease is a significant milestone in our ongoing clinical development of sabirnetug, and reflects our commitment to advancing the collective understanding about the underlying pathology of Alzheimer’s disease and developing a next-generation treatment for this burdensome disease,” said Daniel O’Connell, Chief Executive Officer of Acumen.
The publication titled, “INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer's disease,” is available online here.
ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug in patients with early Alzheimer’s disease. 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. The first patient was dosed in ALTITUDE-AD in May 2024, and Acumen expects to complete enrollment in the first half of 2025.
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 INTERCEPT-AD (Phase 1)
Completed in 2023, INTERCEPT-AD was a Phase 1, U.S.-based, multi-center, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and tolerability, and establishing clinical proof of mechanism, of sabirnetug in patients with early Alzheimer’s disease (AD). Sixty-five individuals with early symptomatic AD (mild cognitive impairment or mild dementia due to AD) enrolled in this first-in-human study of sabirnetug. The INTERCEPT-AD study consisted of single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts and was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and target engagement of intravenous doses of sabirnetug. More information can be found on www.clinicaltrials.gov, NCT identifier NCT04931459.
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 therapeutic potential and potential clinical efficacy of Acumen’s product candidate, sabirnetug (ACU193) and the timing of enrollment completion of 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
What were the key results of ABOS's Phase 1 INTERCEPT-AD trial for sabirnetug?
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