Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as sabirnetug (ACU193)
sabirnetug · 2 trials · 1 indication
iADRS is a validated composite of cognition and function made up of Alzheimer's Disease Assessment Scale - Cognitive Subscale 13-item (ADAS-Cog13) and the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living scale (ADCS-iADL). ADAS-Cog13 is a rater-administered instrument consisting of 13 items assessing cognitive function areas most typically impaired in AD. ADAS-Cog13 scores range from 0 to 85, with higher scores indicating a greater deficit of global cognition. The ADCS-iADL is a subset of the 23-item ADCS-ADL (items 6a and 7 to 23). The iADLs are more complex skills required to successfully live independently. iADL-items score ranges from 0 to 59 (lower scores indicating greater impairment). The iADRS is calculated as a linear combination of total scores from the ADAS-Cog13 and ADCS-iADL. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance.
Cmax (Maximum concentration, determined directly from individual concentration-time data)
Tmax (Time of the maximum concentration)
λz (The observed terminal rate constant; estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile)
T1/2 (The observed terminal half-life)
AUC168h (Area under the concentration-time curve during a one-week dosing interval)
AUClast (Area under the concentration-time curve from time zero to the time of the last quantifiable concentration; calculated using the linear trapezoidal rule)
AUCinf (Area under the concentration-time curve from time zero extrapolated to infinity)
AUCExtrap (%)(The percentage of AUCinf based on extrapolation)
Clast (The last quantifiable concentration determined directly from individual concentration-time data)
Tlast (Time of the last quantifiable concentration)
| Arm | Type | Description |
|---|---|---|
| Double-blind Treatment (DBT) Period: sabirnetug 35 mg/kg | EXPERIMENTAL | Participants will receive sabirnetug, 35 milligrams per kilogram (mg/kg), Q4W as intravenous (IV) infusion during the DBT period. |
| DBT Period: sabirnetug 50 mg/kg | EXPERIMENTAL | Participants will receive sabirnetug, 35 mg/kg, for the first two doses, followed by sabirnetug, 50 mg/kg, Q4W as an IV infusion during the DBT period. |
| DBT Period: Placebo | PLACEBO_COMPARATOR | Participants will receive sabirnetug matching placebo, Q4W as an IV infusion during the DBT period. |
| Open-Label Extension (OLE) Period: sabirnetug 35 mg/kg | EXPERIMENTAL | Participants will receive sabirnetug, 35 mg/kg, Q4W as an IV infusion during the OLE period. |
| Arm 1 | EXPERIMENTAL | 12 participants receive sabirnetug by intravenous infusion |
| Arm 2 | EXPERIMENTAL | 16 participants receive sabirnetug + rHuPH20 by subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| sabirnetug | DRUG | Intravenous sabirnetug |
| Placebo | DRUG | Intravenous Placebo |
| sabirnetug (ACU193) | DRUG | sabirnetug by intravenous infusion |
| Sabirnetug + rHuPH20 | COMBINATION_PRODUCT | sabirnetug + rHuPH20 by subcutaneous injection |
Inclusion Criteria: * Body weight of at least 30 kilograms (kg) (66 pounds \[lbs\]) and no more than 160 kg (352 lbs) at Screening * Must consent to apolipoprotein E4 (APOE4) genotype status assessment * Must meet all of the following criteria 1. National Institute on Aging-Alzheimer's Associati...
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Sabirnetug is being developed for the treatment of Alzheimer disease. It is an investigational therapy in Phase 2 clinical development, studied in participants with early Alzheimer's disease. It has not been approved for any indication.
Sabirnetug targets amyloid beta oligomers, known as AβOs. These soluble oligomers are considered a toxic form of amyloid beta in Alzheimer disease. By binding AβOs, sabirnetug is designed to address this specific aggregated species rather than amyloid plaques.
Sabirnetug is being developed by Acumen Pharmaceuticals, Inc., which trades under the ticker ABOS. The company is advancing the asset in Alzheimer disease through Phase 2 clinical testing.
Sabirnetug is in Phase 2 clinical development. Its lead trial, ALTITUDE-AD, is a Phase 2 study in early Alzheimer's disease that is active and not currently recruiting. The drug is investigational and has not received FDA approval.
Sabirnetug has been studied in two trials. NCT06335173, known as ALTITUDE-AD, is a Phase 2 efficacy and safety study in early Alzheimer's disease with 542 participants. NCT06511570 was a completed Phase 1 study comparing intravenous and subcutaneous formulations in 28 healthy participants.
Yes, sabirnetug is also known as ACU193. ACU193 was the earlier designation for the same compound, and sabirnetug is the current name used by Acumen Pharmaceuticals. Both names refer to the same anti-AβO antibody in development for Alzheimer disease.