ProMIS Neurosciences Inc. announced that the Company dosed the first subjects in a first-in-human Phase 1a clinical trial of PMN310 as a potential treatment for Alzheimer's disease (AD). PMN310 is the Company's novel monoclonal antibody that is designed to be highly selective for toxic oligomers of amyloid-beta (Ab), which are believed to be a major driver of AD. In this Phase 1a clinical trial, will enroll up to five cohorts of eight adult healthy volunteers, each receiving a single dose of PMN310.

The company expects to have initial safety and pharmacokinetic (PK) data to share in the first half of 2024. The company remain committed to investigating the hypothesis that selective targeting of toxic oligomers while avoiding monomer distraction and plaque binding will potentially provide differentiation on both safety and efficacy in AD treatment response. Results from the Phase 1a study will facilitate dose selection for subsequent Phase 1b study in patients with mild Cognitive Impairment (MCI) due to AD and patients with mild AD.

This study will leverage recent results from a third-party clinical study, which demonstrated that plasma and cerebrospinal fluid (CSF) efficacy biomarkers can show a treatment response in as little as three months with oligomer-focused therapy. In addition, Phase 1b study will provide important insights into the safety profile of PMN310, which anticipate may differentiate PMN310 from other available and potentially disease-modifying treatments. The study titled, "A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, tolerability and Pharmacokinetics of PMN310 Infusions in Healthy volunteers," is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK of single ascending doses of intravenous PMN310 in healthy adult volunteers.

Eligible subjects will participate in the 85-day study with one optional follow up assessment at Day 120. Primary PK data will be obtained from day 1 to day 29.