Acumen Pharmaceuticals Doses First Patient in Phase 2 Alzheimer's Trial of Sabirnetug

Acumen Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company based in Charlottesville, VA, has announced the dosing of the first patient in its ALTITUDE-AD Phase 2 clinical trial for the treatment of early Alzheimer's disease (AD) using the novel therapeutic sabirnetug (ACU193). This milestone marks a significant advancement in Acumen's efforts to develop effective treatments targeting toxic soluble amyloid beta oligomers (AβOs), a form of amyloid beta implicated in the neurodegenerative processes of Alzheimer's disease.

The Phase 2 ALTITUDE-AD trial is a multi-center, randomized, double-blind, placebo-controlled study that aims to assess the clinical efficacy and safety of sabirnetug. The trial will involve approximately 540 participants who have early-stage Alzheimer's disease. The participants will be randomly assigned to receive one of two dose levels of sabirnetug (35mg/kg or 50mg/kg every four weeks) or a placebo. The primary measure of the trial's success will be the change in the Integrated Alzheimer’s Disease Rating Scale (iADRS) after 18 months, with secondary outcomes including various cognitive and functional assessments and biomarkers.

Sabirnetug distinguishes itself as the first humanized monoclonal antibody to selectively target toxic soluble AβOs in AD patients. AβOs are known to accumulate early in Alzheimer's disease and are believed to be a persistent cause of synaptic dysfunction and neurodegeneration. By focusing on these toxic oligomers, sabirnetug aims to offer a new approach to treating early Alzheimer's disease.

The trial's design is informed by Phase 1 results from the INTERCEPT-AD study, which involved 62 participants and demonstrated that sabirnetug was well-tolerated with a favorable safety profile. The Phase 1 study also showed significant dose-related reductions in amyloid plaques and provided evidence validating sabirnetug's mechanism of action. These promising results have generated substantial interest from both investigators and patients, contributing to a strong start for the Phase 2 trial.

Beyond the current clinical trial, Acumen Pharmaceuticals is also planning a Phase 1 bioavailability study to explore a subcutaneous dosing option for sabirnetug, which is expected to commence in mid-2024. This initiative underscores the company's commitment to enhancing the accessibility and convenience of its therapeutic offerings.

Sabirnetug has already been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of early AD, reflecting its potential to address a significant unmet medical need. The drug's development is based on extensive research into the role of soluble AβOs in the progression of Alzheimer's disease, with Acumen's scientific founders being pioneers in this field.

The ongoing ALTITUDE-AD trial is currently enrolling participants at multiple sites across the United States and Canada, with plans to expand to additional centers in Europe and the UK. This global effort highlights the widespread hope and collaborative effort in the pursuit of more effective treatments for Alzheimer's disease.

Acumen Pharmaceuticals, headquartered in Charlottesville, VA, with additional offices in Indianapolis, IN, and Newton, MA, is focused on advancing its investigational product candidate, sabirnetug. The company's efforts are grounded in a growing body of evidence that supports the role of toxic soluble amyloid beta oligomers as early and persistent triggers of Alzheimer's disease pathology. For more information about the trial and Acumen's work, interested parties can follow updates through relevant clinical trial registries and Acumen's official communications.