ProMIS Neurosciences Inc. (Nasdaq: PMN) presented positive results from its Phase 1a clinical trial of PMN310, an investigational monoclonal antibody for Alzheimer's disease (AD), at the 17th Clinical Trials on Alzheimer's Disease (CTAD) Conference. The study, involving 40 healthy volunteers, demonstrated that PMN310 was generally well-tolerated and achieved cerebrospinal fluid (CSF) concentrations indicative of potential target engagement in AD patients. These findings support the planned initiation of a Phase 1b clinical trial in AD patients by the end of 2024.
PMN310: Targeting Toxic Amyloid Beta Oligomers
PMN310 is designed to selectively target soluble amyloid beta oligomers (AβOs), believed to be the most toxic form of amyloid beta, relative to monomers and plaques. By focusing on AβOs, ProMIS aims to address a primary driver of Alzheimer's disease pathology, potentially offering a differentiated treatment approach.
Phase 1a Trial: Safety, Tolerability, and Pharmacokinetics
The Phase 1a trial was a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics of PMN310 in healthy volunteers. Participants received single ascending doses of PMN310 (2.5, 5, 10, 20, and 40 mg/kg) administered intravenously. The study assessed drug concentrations in serum and CSF to determine blood-brain barrier penetration and inform dosing strategies.
Larry Altstiel, M.D., Ph.D., Chief Medical Officer of ProMIS Neurosciences, stated, "We are pleased to present additional results from our first-in-human Phase 1a clinical trial of PMN310 that demonstrated PMN310 was generally well tolerated and achieved concentrations in the cerebrospinal fluid indicating its potential for target engagement in AD patients."
Key Findings and Implications
Results from all five cohorts of the Phase 1a trial indicated that PMN310 was generally well-tolerated. Importantly, the study demonstrated that PMN310 crosses the blood-brain barrier in a dose-dependent manner. Pharmacokinetic data suggest that monthly dosing could maintain adequate drug levels for target engagement in AD patients.
Next Steps: Phase 1b Clinical Trial
ProMIS Neurosciences plans to initiate a 12-month, multiple ascending dose Phase 1b clinical trial in 100 patients with mild cognitive impairment due to AD and early AD by the end of 2024. This trial will further evaluate the safety, tolerability, and efficacy of PMN310 in an AD patient population.
"Importantly, these results have confirmed the dosing levels for our planned 12-month, multiple ascending dose Phase 1b clinical trial in 100 patients with mild cognitive impairment due to AD and early AD, which we plan to initiate by year-end 2024," added Dr. Altstiel.
