Acumen Pharma Begins Dosing in ALTITUDE-AD Phase 2 Trial of Sabirnetug

Acumen Pharma Begins Dosing in ALTITUDE-AD Phase 2 Trial of Sabirnetug

By, Admin 11 May 2024

Acumen Pharma begins patient dosing in ALTITUDE-AD phase 2 trial of sabirnetug in early Alzheimer’s disease

Overview

Acumen Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AßOs) for the treatment of Alzheimer’s disease (AD), 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.

Words from CEO: Acumen

  • “Today marks a significant milestone for Acumen and the Alzheimer’s community as we begin the Phase 2 trial of sabirnetug,” said Daniel O’Connell, chief executive officer of Acumen. 
  • “Sabirnetug is at the forefront of the next generation of Alzheimer's therapies, with encouraging phase 1 results supporting its novel mechanism of action and selectivity for toxic amyloid beta oligomers. These results have led to a high level of investigator and patient interest in sabirnetug’s therapeutic potential and a strong start to the trial.”

ALTITUDE-AD

  • ALTITUDE-AD (NCT06335173) is a phase 2, multi-centre, randomized, double-blind, placebo-controlled clinical trial currently enrolling at sites in the United States and Canada, with plans for additional study centres 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. 
  • Standard safety measures and MRIs will also be assessed. Participants who complete the double-blind portion of the study will have the opportunity to continue into an open-label extension.

First Humanized Monoclonal Antibody

Sabirnetug is the first humanized monoclonal antibody to demonstrate in AD patients selective target engagement of AßOs, a soluble and highly toxic form of Aß that accumulates early in AD and is a persistent trigger of synaptic dysfunction and neurodegeneration. Acumen is developing sabirnetug as a potential best-in-class antibody treatment for early AD.

Phase 1 INTERCEPT-AD Trial

  • Positive topline results from 62 participants in the phase 1 INTERCEPT-AD trial (NCT04931459) showed sabirnetug to be well-tolerated with a favourable overall safety profile. 
  • The trial showed statistically significant, dose-related amyloid plaque reduction comparable to approved and late-stage amyloid-directed therapies at similar time points, low overall rates of ARIA-E, and evidence of target engagement that validated proof of mechanism. 
  • The results thus far support sabirnetug’s potential to offer differentiated safety and efficacy as a next-generation treatment for early AD.
  • Additionally, Acumen expects to initiate a phase 1 bioavailability study to support a subcutaneous dosing option of sabirnetug in mid-2024, as announced in November 2023.

About Sabirnetug

  • Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble amyloid beta oligomers (AßOs), which are a highly toxic and pathogenic form of Aß, relative to Aß monomers and amyloid plaques. 
  • Soluble AßOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. 
  • By selectively targeting toxic soluble AßOs, sabirnetug aims to address the hypothesis that soluble AßOs 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 US Food and Drug Administration and was previously evaluated in a phase 1 study in patients with early AD.

ALTITUDE-AD is a phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug (ACU193) 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 approximately 540 individuals with early Alzheimer’s disease (mild cognitive impairment or mild dementia due to AD). The global study is currently enrolling at multiple investigative sites located in the United States and Canada with plans for additional sites in Europe and the UK.

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