ProMIS Neurosciences Receives FDA Fast Track Designation for PMN310 in Alzheimer’s Disease
Tuesday, July 22, 2025
ProMIS Neurosciences has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its lead candidate, PMN310, aimed at treating Alzheimer’s disease (AD).
Alzheimer’s disease currently affects over six million people in the United States and remains one of the leading causes of death and disability in older adults. Despite progress, there is still a pressing need for safer and more effective therapies.
The Fast Track designation is designed to speed up the development and review of drugs that address serious conditions and meet unmet medical needs. This status allows for closer interaction with the FDA and could support a more streamlined path to regulatory approval.
PMN310 is a humanised monoclonal antibody that selectively targets toxic amyloid-beta oligomers, which are believed to play a key role in Alzheimer’s progression. Unlike some existing treatments, PMN310 is designed to avoid binding to plaque, potentially reducing the risk of adverse effects such as brain swelling and bleeding, collectively known as amyloid-related imaging abnormalities (ARIA).
The candidate is currently being evaluated in a Phase 1b trial, named PRECISE-AD, which focuses on patients in the early stages of Alzheimer’s. The study aims to assess safety, tolerability, pharmacokinetics, and disease-relevant biomarkers across multiple ascending dose levels (5, 10, and 20 mg/kg). It is a double-blind, placebo-controlled trial involving patients with Mild Cognitive Impairment and mild Alzheimer’s disease (Stages 3 and 4).
Initial results from a Phase 1a trial (NCT06105528) supported the progression to the ongoing PRECISE-AD study (NCT06750432). The trial has been structured to provide robust data on the potential of PMN310 to deliver targeted treatment while limiting side effects commonly associated with current therapies. The design includes a sample size powered to detect ARIA with 95% confidence and aims to generate meaningful insights into both biomarker response and clinical outcomes.
Interim six-month data are expected in the second quarter of 2026, with final results anticipated by the end of 2026.
Source: promisneurosciences.com
