Drugs / sabirnetug
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT06511570 | Jun → Sep 2024 | Alzheimer disease | Acumen Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04931459 | Jun 2021 → Jun 2023 | Alzheimer disease | Acumen Pharmaceuticals | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT06335173 | Feb 2024 → Oct 2026 expected | Alzheimer disease | Acumen Pharmaceuticals | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-12-02 | Acumen Pharmaceuticals | Results Acumen Pharmaceuticals Highlights Enhanced Brain Delivery™ Technology for Oligomer-Selective Antibodies and Recruitment Strategies for Phase 2 ALTITUDE-AD Clinical Trial at 18th Annual Clinical Trials on Alzheimer’s Disease (CTAD) Conference acumenpharm.com ↗
Additionally, results on clinical trial recruitment from the Phase 2 ALTITUDE-AD clinical trial showed that site databases and physician referrals were the most reliable recruitment methods overall. |
| 2025-11-18 | Acumen Pharmaceuticals | Results Acumen Pharmaceuticals to Present on Recruitment Strategies for Phase 2 ALTITUDE-AD Trial and Enhanced Brain Delivery Technology at 18th Annual Clinical Trials on Alzheimer’s Disease (CTAD) Conference acumenpharm.com ↗
Fusing Transferrin Receptor Binders to the AβO-targeting Antibody Sabirnetug Achieves Increased Brain Penetration in Mice While Preserving Target Binding |
| 2025-07-28 | Acumen Pharmaceuticals | Results Acumen Pharmaceuticals Presents Studies Showing the Utility of a pTau217 Assay in Screening for a Phase 2 Alzheimer’s Disease Trial and Validates Sabirnetug Oligomer-Selectivity, at the Alzheimer’s Association International Conference (AAIC) 2025 acumenpharm.com ↗
Additionally, a nonclinical study revealed sabirnetug achieved the highest selectivity for AβOs over Aβ monomers relative to recombinant lecanemab and aducanumab. |
| 2025-03-19 | Acumen Pharmaceuticals | Results Acumen Pharmaceuticals Announces Topline Results from Phase 1 Study of Subcutaneous Formulation of Sabirnetug in Healthy Volunteers acumenpharm.com ↗
Weekly SC administration of sabirnetug was well-tolerated with systemic exposure supporting further clinical development. |
| 2025-01-09 | Acumen Pharmaceuticals | Results 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 acumenpharm.com ↗
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. |
| 2024-07-28 | Acumen Pharmaceuticals | Results Acumen Pharmaceuticals Presents Patient Experience and Biomarker Data from Phase 1 INTERCEPT-AD Study at the Alzheimer’s Association International Conference (AAIC®) 2024 acumenpharm.com ↗
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 new findings from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193). |
| 2024-03-08 | Acumen Pharmaceuticals | Results Acumen Pharmaceuticals Presents Sabirnetug (ACU193) Fluid Biomarker and Target Engagement Analyses from Phase 1 INTERCEPT-AD Study in Early Alzheimer’s at the AD/PD™ 2024 Annual Meeting acumenpharm.com ↗
Cerebrospinal fluid (CSF) biomarker results are highly supportive of sabirnetug’s downstream pharmacological effects in the brain in early AD |
| 2023-10-27 | Acumen Pharmaceuticals | Results Acumen Pharmaceuticals Presents Late-Breaker Phase 1 Updates Exploring Novel Target Engagement, Dosing Regimen and Safety Findings for ACU193 in Early Alzheimer’s Disease at the 16th Annual Clinical Trials on Alzheimer’s Disease acumenpharm.com ↗
Acumen presented data exploring target engagement modeling of ACU193, the first clinical-stage amyloid beta oligomer (AβO)-targeting antibody, to inform dose selection, plus further analyses of dose-related amyloid plaque reduction and clinical characteristics of ARIA-E, confirming proof-of-mechanism for ACU193 |
| 2023-07-17 | ProMis Neurosciences, Inc | Results ProMIS Showcases Preclinical Data at the Alzheimer’s Association International Conference 2023 on Computationally-Derived Antibody and Vaccine from Alzheimer’s Pipeline promisneurosciences.com ↗
The results demonstrated that PMN310 was able to selectively bind to toxic AβO in AD brain extract and was less impacted by monomer competition than other Aβ-directed antibodies except ACU193, which was equivalent to PMN310. |
| 2023-07-16 | Acumen Pharmaceuticals | Results Acumen Pharmaceuticals Presents Positive Topline Results from First-in-Human Phase 1 Study of ACU193 for Early Alzheimer’s Disease at the Alzheimer’s Association International Conference (AAIC) 2023 acumenpharm.com ↗
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 positive topline results from the Phase 1 INTERCEPT-AD trial of ACU193, the first clinical-stage AβO targeting antibody therapy in early AD, at the Alzheimer’s Association International Conference (AAIC ® ) 2023, taking place in Amsterdam and online from July 16-20, 2023. |
| 2022-10-24 | Acumen Pharmaceuticals | Regulatory Acumen’s ACU193, an Anti-Amyloid Beta Oligomer Antibody, Granted FDA Fast Track Designation for Alzheimer's Disease acumenpharm.com ↗
today announced that ACU193, the first clinical-stage monoclonal antibody that selectively targets toxic soluble amyloid beta oligomers (AβOs), has been granted Fast Track designation for the treatment of early Alzheimer’s disease by the U.S. Food and Drug Administration (FDA). |
All press releases naming this drug 34 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sabirnetug | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06511570 ↗ |
| Known as | ACU193 | “Sabirnetug (ACU193) is a humanized monoclonal antibody, raised against globular species of soluble AβO, that has over 650-fold greater binding affinity for AβOs over monomers...” PMID 39800458 ↗ Jan 2025 |
| Modality | Monoclonal antibody | “Sabirnetug (ACU193) is a humanized monoclonal antibody” PMID 39800458 ↗ Jan 2025 |
| Route | Intravenous | “by intravenous (IV) infusion” NCT04931459 ↗ |