ProMIS Neurosciences Inc. (Nasdaq: PMN) announced positive results from its Phase 1a clinical trial of PMN310, an investigational monoclonal antibody targeting soluble amyloid beta oligomers (AβOs), at the 17th Clinical Trials on Alzheimer's Disease (CTAD) Conference in Madrid, Spain. The data from all five cohorts showed that PMN310 was generally well-tolerated and achieved cerebrospinal fluid (CSF) concentrations suggesting potential target engagement in Alzheimer's disease (AD) patients. The company plans to initiate a Phase 1b clinical trial in patients with mild cognitive impairment due to AD by the end of 2024.
The Phase 1a trial was a randomized, double-blind, placebo-controlled study involving 40 healthy volunteers. Participants received single ascending doses of PMN310 (2.5, 5, 10, 20, and 40 mg/kg) to assess safety, tolerability, and pharmacokinetics. The results indicated that PMN310 crossed the blood-brain barrier in a dose-dependent manner.
Targeting Toxic Amyloid Beta Oligomers
PMN310 is designed to selectively target soluble AβOs, which ProMIS believes are the most toxic and pathogenic form of amyloid beta (Aβ) relative to Aβ monomers and amyloid plaques. Soluble AβOs are considered potent neurotoxins that can bind to neurons, inhibit synaptic function, and induce neurodegeneration. By selectively targeting these toxic oligomers, PMN310 aims to address the underlying cause of neurodegeneration in Alzheimer's disease.
Management Commentary
"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," said Larry Altstiel, M.D., Ph.D., Chief Medical Officer of ProMIS Neurosciences. "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."
Planned Phase 1b Trial
The upcoming Phase 1b trial is a 12-month, multiple ascending dose study in 100 patients with mild cognitive impairment due to AD and early AD. This trial aims to further evaluate the safety, tolerability, and efficacy of PMN310 in a patient population. Initiation of the PMN310 Phase 1b study is planned for the fourth quarter of 2024.
