ProMIS Neurosciences Receives DSMB Approval to Advance to Final Dose Escalation Cohort in Phase 1b Alzheimer’s Trial of PMN310

Core Insights - ProMIS Neurosciences has received unanimous recommendation from the Data and Safety Monitoring Board (DSMB) to proceed to the third and final dose escalation cohort in the PRECISE-AD Phase 1b clinical trial for PMN310, aimed at treating Alzheimer's disease (AD) [2][3] - The trial is on track to enroll 128 patients and is expected to report 6-month interim data in Q2 2026 and final 12-month top-line results in Q4 2026 [1][2] - No cases of amyloid-related imaging abnormalities (ARIA) have been observed to date, indicating a favorable safety profile for PMN310 [1][2][3] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapies for neurodegenerative diseases, particularly Alzheimer's disease [5][6] - The company utilizes its proprietary EpiSelect™ platform to identify Disease Specific Epitopes (DSEs) on misfolded proteins, which are implicated in neurodegenerative diseases [5][9] - PMN310 is a humanized IgG1 antibody designed to selectively target toxic amyloid-beta oligomers while avoiding plaque, potentially reducing ARIA liability [7][8] Clinical Trial Details - The PRECISE-AD trial is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics of multiple ascending doses of PMN310 in patients with Mild Cognitive Impairment due to AD and mild AD [8] - The trial aims to provide insights into the effects of PMN310 on biomarkers associated with AD pathology and clinical outcomes, with a primary focus on safety [8] - The DSMB has cleared the trial to proceed to the next dosing level, increasing the dose from 10 mg/kg in the second cohort to 20 mg/kg in the final cohort [3][7] Future Outlook - The company anticipates that the ongoing clinical trials will provide critical insights into target engagement, neuronal injury, and potential disease-modifying effects of PMN310 [3][8] - ProMIS Neurosciences plans to discuss clinical progress and corporate updates at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025 [4]