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Dagmar Jürgens1, Gerhard Tischler2, Alexander Brener2

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The PRIMUS-AD study is evaluating PRI-002, a novel peptide drug, for safety and efficacy in Alzheimer's Disease (AD) patients. Results are anticipated mid-2026, offering potential new therapeutic benefits.

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Area of Science:

  • Neuroscience
  • Pharmacology
  • Clinical Trials

Background:

  • PRI-002 is an all-D-enantiomeric peptide designed to break down toxic amyloid-beta (Aβ) oligomers into harmless monomers.
  • It is hypothesized to reduce neurotoxicity and restore synaptic plasticity in early stages of Alzheimer's Disease (AD).
  • PRI-002 has shown to be safe and well-tolerated in previous studies involving healthy volunteers and patients with mild cognitive impairment (MCI) or mild AD.

Purpose of the Study:

  • To assess the safety and efficacy of PRI-002 in patients diagnosed with MCI or mild dementia due to AD.
  • To evaluate the therapeutic benefit of PRI-002 through a randomized, double-blind, placebo-controlled clinical trial.

Main Methods:

  • The PRImus-AD study is a Phase 2, randomized, double-blind, placebo-controlled trial involving approximately 300 patients across six European countries.
  • Patients are stratified by disease state (MCI or mild dementia) and APOE e4 status, then randomized (1:1:1) to receive 300 mg PRI-002, 600 mg PRI-002, or placebo daily for 48 to 96 weeks.
  • Confirmation of AD pathology is done via cerebrospinal fluid (CSF) analysis or Amyloid-PET scans. The primary efficacy endpoint is the change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) at week 48.

Main Results:

  • Screening of 540 patients was completed three months ahead of schedule, with approximately 300 eligible patients enrolled.
  • A blinded sample size recalculation confirmed the initial enrollment numbers.
  • Close monitoring for ARIA (Adverse Reactions to Internalized Amyloid) is in place for the first 90 patients until week 24, despite PRI-002 not being expected to induce ARIA.

Conclusions:

  • The PRIMUS-AD Phase 2 study aims to enroll about 300 patients with MCI and mild dementia due to AD.
  • The study will determine the safety and therapeutic benefit of PRI-002.
  • Study results are projected to be available by mid-2026.