Acumen Pharmaceuticals Announces Topline Results from Phase 1 Study of Subcutaneous Formulation of Sabirnetug in Healthy Volunteers
Acumen Pharmaceuticals (NASDAQ: ABOS) has announced positive topline results from its Phase 1 study comparing subcutaneous (SC) and intravenous (IV) formulations of sabirnetug in healthy volunteers. The study demonstrated that weekly SC administration of sabirnetug was well-tolerated, with sufficient systemic exposure to support further clinical development.
The trial included 12 subjects receiving single IV doses of 2,800 mg and 16 subjects receiving four weekly SC doses of 1,200 mg. The most common adverse events were mild injection site reactions (62.5%), which all resolved. The SC formulation utilizes Halozyme's ENHANZE® drug delivery technology, enabling large volume SC injection with improved dispersion and absorption.
Sabirnetug, the first humanized monoclonal antibody showing selective target engagement of amyloid beta oligomers (AβOs) in Alzheimer's disease patients, is being developed as a more convenient administration option compared to IV treatment. The Phase 2 ALTITUDE-AD study of IV sabirnetug is currently ongoing.
Acumen Pharmaceuticals (NASDAQ: ABOS) ha annunciato risultati positivi preliminari dal suo studio di Fase 1 che confronta le formulazioni sottocutanee (SC) e endovenose (IV) di sabirnetug in volontari sani. Lo studio ha dimostrato che la somministrazione settimanale di sabirnetug per via SC è stata ben tollerata, con un'adeguata esposizione sistemica a supporto di ulteriori sviluppi clinici.
Il trial ha incluso 12 soggetti che hanno ricevuto dosi singole IV di 2.800 mg e 16 soggetti che hanno ricevuto quattro dosi settimanali SC di 1.200 mg. Gli eventi avversi più comuni sono stati reazioni lievi nel sito di iniezione (62,5%), tutte risolte. La formulazione SC utilizza la tecnologia di somministrazione di farmaci ENHANZE® di Halozyme, che consente iniezioni SC di grande volume con una migliore dispersione e assorbimento.
Sabirnetug, il primo anticorpo monoclonale umanizzato che mostra un impegno selettivo verso gli oligomeri di beta-amiloide (AβOs) nei pazienti affetti da Alzheimer, è in fase di sviluppo come opzione di somministrazione più conveniente rispetto al trattamento IV. Lo studio di Fase 2 ALTITUDE-AD di sabirnetug IV è attualmente in corso.
Acumen Pharmaceuticals (NASDAQ: ABOS) ha anunciado resultados positivos preliminares de su estudio de Fase 1 que compara las formulaciones subcutáneas (SC) y intravenosas (IV) de sabirnetug en voluntarios sanos. El estudio demostró que la administración semanal de sabirnetug por vía SC fue bien tolerada, con una exposición sistémica suficiente para apoyar el desarrollo clínico adicional.
El ensayo incluyó 12 sujetos que recibieron dosis IV únicas de 2,800 mg y 16 sujetos que recibieron cuatro dosis semanales SC de 1,200 mg. Los eventos adversos más comunes fueron reacciones leves en el sitio de inyección (62.5%), que se resolvieron todas. La formulación SC utiliza la tecnología de entrega de medicamentos ENHANZE® de Halozyme, que permite inyecciones SC de gran volumen con una mejor dispersión y absorción.
Sabirnetug, el primer anticuerpo monoclonal humanizado que muestra un compromiso selectivo con los oligómeros de beta-amiloide (AβOs) en pacientes con enfermedad de Alzheimer, se está desarrollando como una opción de administración más conveniente en comparación con el tratamiento IV. El estudio de Fase 2 ALTITUDE-AD de sabirnetug IV está actualmente en curso.
Acumen Pharmaceuticals (NASDAQ: ABOS)는 건강한 자원봉사자를 대상으로 한 sabirnetug의 피하(SC) 및 정맥(IV) 제형을 비교하는 1상 연구에서 긍정적인 초기 결과를 발표했습니다. 이 연구는 sabirnetug의 주간 SC 투여가 잘 견뎌졌으며, 추가 임상 개발을 지원할 수 있는 충분한 전신 노출을 보여주었습니다.
이 시험에는 2,800mg의 단일 IV 용량을 받은 12명의 피험자와 1,200mg의 네 번의 주간 SC 용량을 받은 16명의 피험자가 포함되었습니다. 가장 흔한 부작용은 주사 부위의 가벼운 반응(62.5%)이었으며, 모두 해결되었습니다. SC 제형은 Halozyme의 ENHANZE® 약물 전달 기술을 활용하여 대용량 SC 주사를 개선된 분산 및 흡수로 가능하게 합니다.
Sabirnetug는 알츠하이머병 환자에서 아밀로이드 베타 올리고머(AβOs)에 대한 선택적 표적 결합을 보여주는 최초의 인간화 단클론 항체로, IV 치료에 비해 더 편리한 투여 옵션으로 개발되고 있습니다. sabirnetug IV의 2상 ALTITUDE-AD 연구가 현재 진행 중입니다.
Acumen Pharmaceuticals (NASDAQ: ABOS) a annoncé des résultats préliminaires positifs de son étude de Phase 1 comparant les formulations sous-cutanées (SC) et intraveineuses (IV) de sabirnetug chez des volontaires sains. L'étude a démontré que l'administration hebdomadaire de sabirnetug par voie SC était bien tolérée, avec une exposition systémique suffisante pour soutenir un développement clinique ultérieur.
L'essai a inclus 12 sujets recevant des doses IV uniques de 2 800 mg et 16 sujets recevant quatre doses SC hebdomadaires de 1 200 mg. Les événements indésirables les plus courants étaient des réactions légères au site d'injection (62,5 %), toutes résolues. La formulation SC utilise la technologie de délivrance de médicaments ENHANZE® de Halozyme, permettant des injections SC de grand volume avec une meilleure dispersion et absorption.
Sabirnetug, le premier anticorps monoclonal humanisé montrant un engagement ciblé sélectif des oligomères de bêta-amyloïde (AβOs) chez les patients atteints de la maladie d'Alzheimer, est en cours de développement comme une option d'administration plus pratique par rapport au traitement IV. L'étude de Phase 2 ALTITUDE-AD de sabirnetug IV est actuellement en cours.
Acumen Pharmaceuticals (NASDAQ: ABOS) hat positive vorläufige Ergebnisse aus seiner Phase-1-Studie veröffentlicht, die subkutane (SC) und intravenöse (IV) Formulierungen von sabirnetug bei gesunden Probanden vergleicht. Die Studie zeigte, dass die wöchentliche SC-Verabreichung von sabirnetug gut vertragen wurde und eine ausreichende systemische Exposition aufwies, um die weitere klinische Entwicklung zu unterstützen.
Die Studie umfasste 12 Probanden, die eine einzelne IV-Dosis von 2.800 mg erhielten, und 16 Probanden, die vier wöchentliche SC-Dosen von 1.200 mg erhielten. Die häufigsten unerwünschten Ereignisse waren leichte Reaktionen an der Injektionsstelle (62,5%), die alle abheilten. Die SC-Formulierung nutzt die ENHANZE®-Medikamentenabgabetechnologie von Halozyme, die große SC-Injektionen mit verbesserter Verteilung und Absorption ermöglicht.
Sabirnetug, der erste humanisierte monoklonale Antikörper, der eine selektive Zielbindung an Amyloid-Beta-Oligomere (AβOs) bei Alzheimer-Patienten zeigt, wird als eine bequemere Verabreichungsoption im Vergleich zur IV-Behandlung entwickelt. Die Phase-2-Studie ALTITUDE-AD zu sabirnetug IV läuft derzeit.
- Successful Phase 1 results supporting further development of subcutaneous formulation
- Well-tolerated safety profile with only mild adverse events
- Achieved sufficient systemic exposure for clinical advancement
- Potential for improved patient convenience compared to IV administration
- 62.5% of subjects experienced injection site reactions
Insights
Acumen's Phase 1 results for subcutaneous (SC) sabirnetug represent an important formulation advancement that could significantly improve the treatment experience for Alzheimer's patients. The study demonstrated that weekly SC administration was well-tolerated with only mild injection site reactions in
The pharmacokinetic profile achieved with SC administration supports further clinical development - a critical milestone for this alternative delivery method. While the current IV formulation is being evaluated in the Phase 2 ALTITUDE-AD study, this SC development creates a parallel opportunity that could substantially reduce treatment burden.
The partnership with Halozyme leveraging their ENHANZE® technology is particularly notable. This delivery platform has already been validated in nine approved therapies, reducing development risk for Acumen's SC formulation. ENHANZE® enables large volume SC injection through its recombinant human hyaluronidase enzyme (rHuPH20), which increases dispersion and absorption.
The potential market implications are substantial. If sabirnetug proves effective in treating Alzheimer's, an SC formulation could greatly expand its commercial potential by enabling more convenient administration in outpatient settings rather than requiring infusion center visits. This development pathway mirrors successful strategies seen with other monoclonal antibodies that transitioned from IV to SC administration, typically resulting in improved market penetration.
This Phase 1 study represents a positive but incremental advancement in Acumen's clinical development program. The successful demonstration of a subcutaneous (SC) formulation's tolerability and appropriate pharmacokinetics is strategically significant, but investors should understand its proper context within the broader development timeline.
The primary value driver for ABOS remains the efficacy and safety profile of sabirnetug in treating Alzheimer's disease, which is being evaluated in the ongoing Phase 2 ALTITUDE-AD study. The SC formulation development is best viewed as a parallel initiative that enhances the drug's commercial potential if efficacy is ultimately demonstrated.
From a competitive standpoint, SC administration could provide Acumen with a meaningful advantage in the Alzheimer's treatment landscape. Several competing monoclonal antibodies targeting amyloid beta require IV administration, which necessitates infusion center visits and monitoring. The potential for weekly SC dosing could significantly reduce healthcare system burden and improve patient compliance, particularly important for a chronic neurodegenerative condition.
The partnership with Halozyme for the ENHANZE® technology demonstrates prudent development strategy, leveraging an established delivery platform rather than developing proprietary formulation technology. This approach likely accelerates development timelines while reducing technical risk.
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- Weekly subcutaneous administration of sabirnetug was well-tolerated in the Phase 1 study
- Systemic exposure following subcutaneous administration supports further clinical development
- Development of sabirnetug delivered subcutaneously has the potential for decreased treatment burden and increased patient convenience
NEWTON, Mass., March 19, 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 topline results from its Phase 1 study comparing pharmacokinetics (PK) between subcutaneous (SC) and intravenous (IV) formulations of sabirnetug in healthy volunteers. Weekly SC administration of sabirnetug was well-tolerated with systemic exposure supporting further clinical development.
“We are pleased that the results of our initial clinical study support further clinical development of sabirnetug administered subcutaneously, underscoring the potential for increasing patient convenience of this formulation relative to intravenous treatment,” said Daniel O’Connell, Chief Executive Officer of Acumen. “The timely completion of this study highlights the strength of our clinical team and partners, and our commitment to advancing our clinical pipeline efficiently and effectively. Based on these data, we believe that further development of subcutaneous sabirnetug as a more convenient administration option for patients is warranted.”
The Phase 1 study in healthy volunteers enrolled 12 subjects who received single IV doses of 2,800 mg and 16 subjects who received four weekly SC doses of 1,200 mg. The most frequently reported adverse events included injection site reactions (
Sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AβOs in patients with AD. The SC formulation of sabirnetug is co-formulated with Halozyme’s proprietary ENHANZE® drug delivery technology (recombinant human hyaluronidase enzyme, rHuPH20) that enables large volume SC injection with increased dispersion and absorption of co-administered therapies. ENHANZE® has been commercially validated as a component of nine approved therapies.
The Phase 2 ALTITUDE-AD study of IV sabirnetug is currently ongoing.
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, UK, and the European Union. More information can be found on www.clinicaltrials.gov, NCT identifier NCT06335173.
About Halozyme’s ENHANZE® Technology
Halozyme's commercially validated proprietary ENHANZE® drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume and delivery rates of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered rapidly in minutes subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections.
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 its subcutaneous formulation. l. 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
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