Amyloid β Oligomer–Targeting Therapy for Alzheimer Disease Receives FDA Fast Track Designation

The Food and Drug Administration (FDA) has granted Fast Track designation to PMN310 (ProMIS Neurosciences, Cambridge, MA), a therapeutic humanized monoclonal antibody (mAb) being developed for the treatment of Alzheimer disease (AD). PMN310 is designed to selectively target toxic amyloid β oligomers (AβO), potentially reducing the risk of amyloid-related imaging abnormalities (ARIA) associated with anti-amyloid therapies that target plaques. Fast Track designation enables more frequent engagement with the FDA and may help expedite the regulatory review process for therapies that address serious unmet medical needs.

PMN310 is undergoing evaluation for the treatment of early AD in the ongoing phase 1 PRECISE-AD clinical trial (NCT06750432). In this randomized, double-blind, placebo-controlled study, participants with mild cognitive impairment due to AD or mild AD will receive PMN310 (350 mg, 700 mg, or 1400 mg) or placebo. Primary outcomes include measures of safety, tolerability, and biomarker response. According to a statement from ProMIS Neurosciences, interim results from PRECISE-AD are expected in the second quarter of 2026, with final results expected in the fourth quarter of 2026.

“We designed PMN310 with a goal of providing Alzheimer’s patients with a safer and more efficacious treatment option, which we believe represents the next generation of Alzheimer’s therapeutics,” said Neil Warma, President and CEO of ProMIS Neurosciences. “By selectively targeting only the most harmful, toxic forms of amyloid-beta, we believe PMN310 has the potential to reduce the serious side effects seen with current Alzheimer’s treatments, namely brain swelling and bleeding known as ARIA, while also delivering improved therapeutic benefit to patients.”