Acumen begins Phase II Alzheimer's trial with first patient

Acumen Pharmaceuticals has begun the ALTITUDE-AD Phase II trial, aiming to assess the clinical efficacy and safety of its leading drug, sabirnetug (ACU193), in patients with early-stage Alzheimer’s disease. The trial, which will eventually include around 540 participants, involves administering the first patient with the drug.

The company, based in the United States, is focusing on combating Alzheimer’s by targeting soluble amyloid beta oligomers (AβOs), which are linked to the disease's pathology and neurodegeneration. Sabirnetug is designed to interact with these toxic oligomers, preventing their harmful effects on dendritic spines, thereby preserving neuronal function.

The trial will enroll approximately 540 individuals diagnosed with early Alzheimer’s. Participants will be randomly assigned to receive either one of two doses of sabirnetug — 35mg/kg or 50mg/kg every four weeks — or a placebo. The dosage levels were chosen based on modeling data from Acumen’s previous Phase I INTERCEPT-AD trial. This earlier trial demonstrated that sabirnetug was well-tolerated and had a favorable safety profile while achieving near-maximal central target engagement of AβOs.

The primary endpoint of the Phase II ALTITUDE-AD study is to measure the change from baseline in the Integrated Alzheimer’s Disease Rating Scale (iADRS) over 18 months. Secondary endpoints include evaluations using the Clinical Dementia Rating – Sum of Boxes scale (CDR-SB), ADAS-Cog13, ADCS-ADL, and various Alzheimer's disease biomarkers.

Acumen CEO Daniel O’Connell highlighted the significance of sabirnetug, stating that it represents the forefront of the next generation of Alzheimer’s therapies. He noted the encouraging Phase I results, which support its unique mechanism of action and selectivity for toxic amyloid beta oligomers.

Recently, Acumen formed a strategic partnership with Swiss contract manufacturer Lonza to advance the development of sabirnetug further. This collaboration aims to leverage Lonza's expertise to enhance the drug's development process.

According to GlobalData, the current US market for Alzheimer’s disease-related treatments is valued at approximately $4.5 billion. This market is expected to grow significantly, reaching about $9.5 billion by 2028.