ProMIS Clears Safety Hurdle, Enters Final Dosing Cohort in Alzheimer’s Trial

September 3, 2025

DENVER, Colo., Sep 03, 2025 (247marketnews.com)- ProMIS Neurosciences (NASDAQ:PMN) stated that the independent Data and Safety Monitoring Board (DSMB) has given the green light to proceed to the third and final dose escalation cohort in its Phase 1b Alzheimer’s trial of PMN310.

The decision follows full enrollment of Cohort 2 and a clean safety review, with no cases of amyloid-related imaging abnormalities (ARIA) observed to date. Enrollment and dosing for Cohort 3 are now underway, moving from a 10 mg/kg dose to 20 mg/kg.

This advancement keeps the company on track to report 6-month interim data in Q2 2026, followed by top-line 12-month results in Q4 2026. The trial is expected to enroll 128 patients and will assess both clinical and biomarker outcomes.

CEO Neil Warma called the DSMB’s recommendation a validation of PMN310’s differentiated approach, emphasizing its design to avoid amyloid plaque, unlike other therapies in the space, and selectively target toxic amyloid-beta oligomers, the species most associated with neuronal damage.

Chief Medical Officer Dr. Larry Altstiel added that the encouraging safety profile aligns with PMN310’s targeted mechanism, and said upcoming biomarker data, including pTau217, NfL, and Abeta42/40 ratios, will help define the therapy’s disease-modifying potential.

This update adds momentum following the recent FDA Fast Track designation for PMN310. Warma will provide further insights during the company’s presentation at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025.

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