Acumen Pharmaceuticals has dosed the first patient in ALTITUDE-AD, a Phase II trial designed to evaluate the clinical efficacy and safety of its lead drug sabirnetug (ACU193) in patients with early Alzheimer’s disease.
The US-based company’s approach to tackling Alzheimer’s involves targeting soluble amyloid beta oligomers (AβOs), which are associated with the disease pathology and neurodegeneration. Sabirnetug targets these toxic oligomers stopping their interaction with dendritic spines and thus preserving neuronal function.
A total of around 540 people with early Alzheimer’s will be enrolled in the Phase II trial and be randomised to receive one of two dose levels of sabirnetug — 35mg/kg or 50mg/kg once every four weeks — or a placebo.
Dose levels for the trial have been determined to approach maximal target engagement based on modelling data from the company’s Phase I INTERCEPT-AD trial results, which showed sabirnetug to be well-tolerated and with a favourable safety profile. Additionally, researchers found that the drug approached maximal central target engagement of AβOs beyond expected levels.
The Phase II ALTITUDE-AD study will measure change from baseline in the Integrated Alzheimer’s Disease Rating Scale (iADRS) at 18 months as a primary endpoint. Secondary endpoints include the Clinical Dementia Rating – Sum of Boxes scale (CDR-SB), ADAS-Cog13, ADCS-ADL and various AD biomarkers.
Acumen CEO Daniel O’Connell commented: “Sabirnetug is at the forefront of the next generation of Alzheimer's therapies, with encouraging Phase I results supporting its novel mechanism of action and selectivity for toxic amyloid beta oligomers.”
Acumen recently entered into a strategic partnership with Swiss contract manufacturer Lonza to further the development of sabirnetug.
According to GlobalData, the general US market for Alzheimer’s disease-related treatments stands at around $4.5bn, with the market expected to grow to $9.5bn by 2028.
GlobalData is the parent company of Pharmaceutical Technology.
