Non-Plaque Binding Therapy Fast Tracked for Alzheimer Disease

The Food and Drug Administration (FDA) has granted Fast Track designation to PMN310 for the treatment of Alzheimer disease (AD).

PMN310 is an investigational monoclonal antibody designed to selectively target soluble amyloid beta oligomers, while potentially reducing the risk of amyloid-related imaging abnormalities (ARIA). In a phase 1a trial in 40 healthy volunteers (ClinicalTrials.gov Identifier: NCT06105528), PMN310 was found to be generally well tolerated in all 5 single ascending doses and had crossed the blood brain barrier in a dose dependent manner.

A phase 1b trial in patients with AD (PRECISE-AD; ClinicalTrials.gov Identifier: NCT06750432) is currently underway. The randomized, double-blind, placebo-controlled study is evaluating the safety, tolerability, and pharmacokinetics of multiple ascending doses of intravenous PMN310 in patients with mild cognitive impairment due to AD and in those with mild AD (stage 3 and stage 4).

The study will aim to assess the safety of the product based on the number and severity of adverse events, including ARIA, as well as biomarkers associated with AD pathology and clinical outcomes (ie, mean change in plasma p-tau217 and on amyloid positron emission tomography). Interim 6-month data are expected in the second quarter of 2026, with final results anticipated in the fourth quarter of 2026.

“We designed PMN310 with a goal of providing Alzheimer patients with a safer and more efficacious treatment option, which we believe represents the next generation of Alzheimer therapeutics,” said Neil Warma, President and Chief Executive Officer 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 treatments, namely brain swelling and bleeding known as ARIA, while also delivering improved therapeutic benefit to patients.”

This article originally appeared on MPR