ProMIS Neurosciences Reveals Positive PMN310 Phase 1a Trial Data at CTAD Conference

ProMIS Neurosciences Inc., a biotechnology company dedicated to developing antibody therapeutics for neurodegenerative diseases, has announced promising results from its Phase 1a clinical trial of PMN310. The company presented these findings at the 17th Clinical Trials on Alzheimer's Disease (CTAD) Conference in Madrid, Spain.

PMN310, an investigational humanized monoclonal antibody, is designed to selectively target soluble amyloid beta oligomers (AβOs), which are believed to be the most toxic and pathogenic form of amyloid beta in comparison to monomers and plaques.

The Phase 1a clinical trial, conducted in the United States, was a randomized, double-blind, placebo-controlled study involving 40 healthy volunteers. The primary objectives were to assess the safety, tolerability, and pharmacokinetics of PMN310 across five single ascending dose cohorts (2.5, 5, 10, 20, and 40 mg/kg). The trial results indicated that PMN310 was generally well-tolerated across all dosage levels, with no significant adverse effects reported.

An important finding was that PMN310 successfully crossed the blood-brain barrier in a dose-dependent manner. This is significant as the antibody needs to reach the brain to engage its target effectively. The pharmacokinetics data suggested that monthly dosing could achieve cerebrospinal fluid (CSF) levels adequate for engaging targets in Alzheimer's disease (AD) patients.

Larry Altstiel, Chief Medical Officer of ProMIS Neurosciences, expressed satisfaction with the trial outcomes, highlighting that the data supports the planned Phase 1b clinical trial. This upcoming trial will involve 100 patients with mild cognitive impairment due to AD and early-stage AD and is set to begin by the end of 2024. The Phase 1b trial will be a 12-month, multiple ascending dose study aimed at further evaluating the safety and efficacy of PMN310.

The positive results from the Phase 1a trial reinforce earlier data and provide a solid foundation for the upcoming trial phase. ProMIS Neurosciences aims to develop PMN310 as a differentiated treatment for Alzheimer's disease by targeting soluble AβOs, which are considered a primary driver of the disease's pathology.

PMN310's development is supported by extensive scientific evidence suggesting that soluble amyloid-beta oligomers are potent neurotoxins that impair synaptic function and induce neurodegeneration. By selectively targeting these toxic oligomers, PMN310 has the potential to address the underlying causes of neurodegenerative processes in AD.

ProMIS Neurosciences is a clinical-stage biotechnology company based in Cambridge, Massachusetts, and Toronto, Ontario. The company's proprietary target discovery engine uses a thermodynamic and computational platform to identify novel disease-specific epitopes on misfolded proteins. This approach enables the development of targeted antibody therapeutics for neurodegenerative diseases such as Alzheimer's disease, amyotrophic lateral sclerosis (ALS), and multiple system atrophy (MSA).

In summary, the Phase 1a clinical trial results for PMN310 are encouraging, showing good tolerability and promising pharmacokinetic properties. The upcoming Phase 1b trial will further investigate the therapeutic potential of PMN310 in Alzheimer's patients, marking a significant step forward in ProMIS Neurosciences' mission to develop effective treatments for neurodegenerative diseases.