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ProMIS Neurosciences Initiates Phase 1b Clinical Trial (PRECISE-AD) in Alzheimer’s Disease
Targeting toxic oligomers without binding to plaque, designed to reduce the risk of ARIA and potentially deliver enhanced outcomes for patients CAMBRIDGE,
About this update from Promis Neurosciences Inc.
[{"type":"text","content":"Targeting toxic oligomers without binding to plaque, designed to reduce the risk of ARIA and potentially deliver enhanced outcomes for patients\nCAMBRIDGE, Massachusetts, Jan. 10, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on developing precision therapies for neurodegenerative diseases, today announced the initiation of its Phase 1b clinical trial (PRECISE-AD) evaluating its lead therapeutic candidate, PMN310, in Alzheimer’s disease (AD). PMN310, a humanized IgG1 antibody, is engineered to selectively target toxic oligomers of amyloid-beta (AβO)—which are believed to be a key driver of Alzheimer’s pathology—while avoiding interaction with plaque deposits. This mechanism is designed to help reduce the risk of amyloid-related imaging abnormalities (ARIA), a common side effect associated with existing therapies, potentially offering a differentiated product profile. The ongoing Phase 1b PRECISE-AD trial will assess the safety, tolerability, and pharmacokinetics of PMN310 over 12 months of treatment in 100 patients with mild cognitive impairment (MCI) due to AD (Stage 3 AD) or early AD (Stage 4 AD). The study will also evaluate key biomarkers and clinical measures of efficacy to gather data on PMN310’s therapeutic potential. Results from the recently completed Phase 1a study in healthy volunteers demonstrated a generally favorable safety and tolerability profile, with drug concentrations in cerebrospinal fluid supporting its potential for robust target engagement in patients with AD. “The initiation of the PRECISE-AD trial is a major milestone in our journey to develop PMN310 as a potential treatment for AD,” said Neil Warma, CEO of ProMIS Neurosciences. “Current AD treatments offer only modest efficacy, often accompanied by significant side effect challenges such as ARIA, leaving a substantial unmet need for new options. We believe PMN310 has the potential to deliver on this need through its selective targeting mechanism.” “We have partnered with some of the best AD treatment centers in the U.S. for this trial and they are actively screening and enrolling patients. The PRECISE-AD trial has been carefully designed to generate robust clinical data, including biomarker insights and efficacy signals that will guide the next phase of development. We are excited about...