ProMIS Neurosciences Begins Dosing in Phase 1b Alzheimer’s Trial with PMN310

CAMBRIDGE, Massachusetts – February 25, 2025 – ProMIS Neurosciences Inc. announced today that it has dosed multiple patients in its ongoing PRECISE-AD Phase 1b clinical trial. The trial is evaluating PMN310, the company’s lead humanized monoclonal antibody designed for the treatment of Alzheimer’s disease by selectively targeting soluble amyloid-beta oligomers, a toxic species believed to drive disease progression.

The dosing milestone represents a significant step in the investigation of PMN310’s safety, tolerability, and pharmacokinetics in patients with Alzheimer’s disease. As disclosed in the company’s SEC Form 8-K filing and accompanying press release, the trial will assess multiple ascending dose levels (5, 10, and 20 mg/kg) administered via monthly intravenous infusions over a 12-month period in patients with Stage 3 and Stage 4 Alzheimer’s disease.

In addition to monitoring the primary endpoints, the study will evaluate key biomarkers and clinical measures of efficacy. Frequent magnetic resonance imaging (MRI) scans will be performed to monitor for amyloid-related imaging abnormalities (ARIA), a known concern with current Alzheimer’s treatments. Interim six-month results are expected in the first half of 2026, with topline results anticipated in the second half of 2026.

“This initiation of dosing marks a significant milestone for ProMIS Neurosciences,” said Neil Warma, Chief Executive Officer of the company. “In light of the growing need for more effective and safer treatments for Alzheimer’s disease, we are taking a critical step toward demonstrating the potential of PMN310 to make a real difference for patients and their families.”

The PRECISE-AD trial is being conducted as a randomized, double-blind, placebo-controlled study. Approximately 100 subjects across 22 active sites in the United States are expected to participate. The trial’s design not only aims to provide safety and pharmacokinetic data but also seeks to offer insights on the therapeutic potential of a drug that differentiates itself by targeting toxic soluble amyloid-beta oligomers rather than the monomers or plaques commonly associated with Alzheimer’s pathology.

Investigators, including physicians Yaneicy Gonzalez-Rojas, M.D., and Ahmad Aswad, M.D., emphasized the unmet need for treatment options in Alzheimer’s disease and the promise that PMN310’s selective mechanism of action might offer. As current therapies have shown only modest efficacy and have been associated with adverse events such as ARIA, the clinical community is watching closely as the trial progresses.

ProMIS Neurosciences is positioning PMN310 as a potential advancement in Alzheimer’s treatment based on its novel, selective approach. The company previously completed a Phase 1a clinical study in healthy volunteers and continues to pursue clinical development with the hope of delivering a more effective and well-tolerated option for patients with Alzheimer’s disease.

The results from the ongoing Phase 1b trial will be critical in shaping the future development pathway for PMN310 and the broader strategy of ProMIS Neurosciences in addressing neurodegenerative diseases.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read ProMIS Neurosciences’s 8K filing here.

ProMIS Neurosciences Company Profile

ProMIS Neurosciences, Inc discovers and develops antibody therapies and therapeutic vaccines neurodegenerative diseases and other misfolded protein diseases in Canada. The company’s proprietary discovery platform comprises ProMIS and Collective Coordinates algorithms to predict novel targets known as disease specific epitopes on the molecular surface of misfolded proteins.