ProMIS Neurosciences Inc., a biotechnology company specializing in antibody therapeutics for neurodegenerative diseases, has announced the commencement of a Phase 1a clinical trial for PMN310. This novel monoclonal antibody is designed to selectively target toxic oligomers of amyloid-beta (Aβ), which are implicated in the progression of Alzheimer's disease (AD).
The trial, titled "A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of PMN310 Infusions in Healthy Volunteers," aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of PMN310 in healthy adult volunteers. The study will enroll up to five cohorts of eight participants each, with initial safety and PK data expected in the first half of 2024.
Gail Farfel, Ph.D., CEO of ProMIS Neurosciences, expressed enthusiasm about the trial's potential to advance the company's precision medicine approach in treating neurodegenerative diseases. The company recently secured over $20 million in private placement financing to support this and other research initiatives.
Results from the Phase 1a study will inform dose selection for a subsequent Phase 1b study in patients with Mild Cognitive Impairment (MCI) due to AD and mild AD. This next phase will leverage findings from a third-party clinical study that demonstrated the efficacy of oligomer-focused therapy in showing treatment responses within three months.
ProMIS Neurosciences' proprietary target discovery engine, which includes the ProMIS™ and Collective Coordinates platforms, underpins the development of PMN310 and other antibody therapeutics for neurodegenerative diseases. The company operates out of Toronto, Ontario, and Cambridge, Massachusetts.
This clinical trial represents a pivotal moment for ProMIS Neurosciences as it transitions into a clinical-stage company, with the potential to significantly impact the treatment landscape for Alzheimer's disease and other neurodegenerative conditions.
