Acumen Pharmaceuticals, Inc. announced that the first patient has been dosed with Sabirnetug (ACU193) in the ALTITUDE-AD Phase 2 clinical trial designed to evaluate the clinical efficacy and safety of Sabirnetug in patients with early AD. ALTITUDE-AD (NCT06335173) is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial currently enrolling at sites in the United States and Canada, with plans for additional study centers in Europe and the UK. The study will enroll approximately 540 people with early AD who will be randomized to receive one of two dose levels of Sabirnetug (35mg/kg or 50mg/kg once every four weeks) or placebo.

Dose levels were determined to approach maximal target engagement based on modeling conducted from INTERCEPT-AD Phase 1 study results. The primary endpoint will be change from baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS) at 18 months. Secondary endpoints will include the Clinical Dementia Rating - Sum of Boxes scale (CDR-SB), ADAS-Cog13, ADCS-ADL and various AD biomarkers.

Soluble AbOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AbOs, Sabirnetug aims to address the hypothesis that soluble AbOs are an early and persistent underlying cause of the neurodegenerative process in Alzheimer's disease (AD). Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration and was previously evaluated in a Phase 1 study in patients with early AD.

About ALTITUDE-AD is a Phase 2, multi thecenter, randomized, double- blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug (ACU192) infusions administered once every four weeks in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease. The study will enroll approximately540 individuals with early Alzheimer's disease (mild cognitive impairment or mild dementia due to AD). More information can be found on, NCT identifier NCT06335173.