ProMIS Neurosciences Inc. has commenced a Phase 1b clinical trial, dubbed PRECISE-AD (NCT06750432), to investigate PMN310, its lead therapeutic candidate, for the treatment of Alzheimer's disease. The trial aims to evaluate the safety, tolerability, and pharmacokinetics of PMN310, a humanized IgG1 antibody, in patients with mild cognitive impairment (MCI) due to AD (Stage 3 AD) or early AD (Stage 4 AD).
Targeting Toxic Amyloid-beta Oligomers
PMN310 is engineered to selectively target toxic oligomers of amyloid-beta (AβO), which are believed to be a key driver of Alzheimer's pathology. Unlike some existing therapies, PMN310 is designed to avoid interaction with plaque deposits, potentially reducing the risk of amyloid-related imaging abnormalities (ARIA), a common side effect associated with current Alzheimer's treatments.
Trial Design and Patient Population
The PRECISE-AD trial is a randomized, double-blind, placebo-controlled study that plans to enroll approximately 100 subjects across 22 active sites in the United States. Eligible patients will be dosed monthly with intravenous PMN310 at one of three ascending dose levels (5, 10, 20 mg/kg) or placebo over a 12-month period. The trial will assess safety, tolerability, pharmacokinetics, and pharmacodynamic blood- and brain-based markers of treatment effect at baseline and every three months. Frequent MRI scans will be conducted to monitor for the emergence of ARIA.
Management Perspective
Neil Warma, CEO of ProMIS Neurosciences, stated, "The initiation of the PRECISE-AD trial is a major milestone in our journey to develop PMN310 as a potential treatment for AD. Current AD treatments offer only modest efficacy, often accompanied by significant side effect challenges such as ARIA, leaving a substantial unmet need for new options. We believe PMN310 has the potential to deliver on this need through its selective targeting mechanism."
Differentiated Product Profile
Cameron Olezene, M.D., Principal Investigator at Flourish Research in Philadelphia, emphasized the importance of novel therapeutic approaches: "Monoclonal antibodies targeting toxic amyloid-beta species are the first treatments that have shown disease modifying capacity for Alzheimer's disease. It is often preferable to have multiple therapeutics available as treatment options. Thus, PMN310 is exciting because of its novel targeting of amyloid oligomers, potentially offering another solution for physicians and their patients."
Previous Clinical Data
ProMIS Neurosciences reported that results from its recently completed Phase 1a study in healthy volunteers demonstrated a generally favorable safety and tolerability profile for PMN310. The company anticipates sharing interim data from the PRECISE-AD trial in the first half of 2026.
