NOTE: The task description references "NCT06563895" as an Alzheimer's disease trial, but this trial is actually for transthyretin (TTR) amyloidosis prevention — NOT Alzheimer's disease. This page documents the actual Acoramidis trials.
Acoramidis (formerly known as AG10, ALXN2060) is a near-complete (>90%) transthyretin (TTR) stabilizer developed by Eidos Therapeutics, a BridgeBio company. It is designed to mimic the protective properties of the naturally occurring TTR T119M mutation, which prevents TTR from dissociating and forming amyloid deposits.
Acoramidis is being developed for the treatment of TTR amyloidosis, including:
ATTR-CM: Transthyretin amyloid cardiomyopathy
ATTR-PN: Transthyretin amyloid polyneuropathy
Prevention: Asymptomatic TTR variant carriers
Mechanism of Action
Acoramidis binds to the thyroxine binding site on the TTR tetramer, stabilizing the native tetrameric structure and preventing dissociation into monomers — the rate-limiting step in TTR amyloidogenesis.
Key Mechanism Points
Near-complete stabilization: >90% TTR stabilization across entire dosing interval
Prevents both cardiac and neurological manifestations
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Acoramidis Clinical Trials
NOTE: The task description references "NCT06563895" as an Alzheimer's disease trial, but this trial is actually for transthyretin (TTR) amyloidosis prevention — NOT Alzheimer's disease. This page documents the actual Acoramidis trials.
Overview
Mermaid diagram (expand to render)
Acoramidis (formerly known as AG10, ALXN2060) is a near-complete (>90%) transthyretin (TTR) stabilizer developed by Eidos Therapeutics, a BridgeBio company. It is designed to mimic the protective properties of the naturally occurring TTR T119M mutation, which prevents TTR from dissociating and forming amyloid deposits.
Acoramidis is being developed for the treatment of TTR amyloidosis, including:
ATTR-CM: Transthyretin amyloid cardiomyopathy
ATTR-PN: Transthyretin amyloid polyneuropathy
Prevention: Asymptomatic TTR variant carriers
Mechanism of Action
Acoramidis binds to the thyroxine binding site on the TTR tetramer, stabilizing the native tetrameric structure and preventing dissociation into monomers — the rate-limiting step in TTR amyloidogenesis.
Key Mechanism Points
Near-complete stabilization: >90% TTR stabilization across entire dosing interval
Prevents both cardiac and neurological manifestations
Clinical Trials
ACT-EARLY Prevention Trial (NCT06563895)
| Field | Value | |-------|-------| | Trial ID | NCT06563895 | | Phase | Phase 3 | | Sponsor | Eidos Therapeutics (BridgeBio) | | Status | RECRUITING | | Enrollment | 582 (estimated) | | Start Date | May 12, 2025 | | Primary Completion | October 2031 | | Completion Date | December 2032 |
Study Design: Randomized, multicenter, double-blind, placebo-controlled, parallel-group, quadruple-masked Phase 3 trial for prevention in asymptomatic TTR variant carriers.
Primary Outcome: Time to development of ATTR (ATTR-CM or ATTR-PN, whichever occurs first, centrally adjudicated) over approximately 7 years.
Secondary Outcomes:
Time to development of ATTR-CM (centrally adjudicated)
Time to development of ATTR-PN (centrally adjudicated)
ATTRibute-CM (NCT04839487)
| Field | Value | |-------|-------| | Trial ID | NCT04839487 | | Phase | Phase 3 | | Sponsor | Eidos Therapeutics (BridgeBio) | | Status | COMPLETED | | Enrollment | 421 |
Results: Acoramidis resulted in a significantly better four-step primary hierarchical outcome containing components of mortality, morbidity, and function than placebo at 30 months in participants with ATTR-CM.
Other Acoramidis Trials
| Trial ID | Phase | Status | Indication | |----------|-------|--------|------------| | NCT04769479 | PK | Completed | Pharmacokinetics in healthy subjects | | NCT04988386 | OLE | Active | Open-label extension in ATTR-CM | | NCT04958135 | PK | Completed | Food effect study | | NCT07116473 | OLE | Active | ACT-EARLY OLE for newly diagnosed ATTR-CM |
Important Note: Despite the task description referencing an "Alzheimer's disease" trial, there is currently no registered ClinicalTrials.gov study investigating Acoramidis for Alzheimer's disease or any other CNS/neurodegenerative disease beyond TTR amyloidosis.
The NCT06563895 trial is specifically for:
Prevention of ATTR in asymptomatic TTR variant carriers
Cardiac and peripheral neurological outcomes (ATTR-CM, ATTR-PN)
NOT for Alzheimer's disease
If an Acoramidis Alzheimer's disease trial exists, it would be either: