Cambridge, Massachusetts — September 3, 2025 — Leads & Copy — ProMIS Neurosciences, Inc. (Nasdaq: PMN) announced that the independent Data and Safety Monitoring Board (DSMB) for its PRECISE-AD Phase 1b clinical trial has unanimously recommended proceeding to the third and final dose escalation cohort for PMN310, a treatment for Alzheimer’s disease (AD).
The recommendation followed a review of safety data through Cohort 2, which is fully enrolled and showed no cases of amyloid-related imaging abnormalities (ARIA). Enrollment for Cohort 3 is underway, keeping the company on track to deliver 6-month interim data in Q2 2026 and final 12-month top-line results in Q4 2026.
The trial is expected to enroll 128 patients.
Neil Warma, President and CEO of ProMIS Neurosciences, stated that the DSMB’s recommendation underscores the steady progress of the Phase 1b program and keeps the company on track for planned data readouts in 2026. He noted that PMN310 is engineered to avoid plaque and precisely target toxic oligomers, unlike therapies directed at amyloid plaque, which are associated with safety concerns.
Larry Altstiel, M.D., Ph.D., Chief Medical Officer of ProMIS Neurosciences, said the safety profile observed with PMN310 is encouraging and consistent with its design as a highly selective antibody targeting toxic oligomers. He added that the company looks forward to assessing a comprehensive biomarker panel as they enter the final cohort.
PMN310 is a humanized IgG1 antibody directed toward toxic amyloid-beta oligomers (AβOs) believed to be a major driver of AD. The DSMB recommended continuation of the trial without modification and provided clearance to continue to the 20mg/kg dose for the final cohort.
Neil Warma will discuss clinical progress and corporate updates at the H.C. Wainwright 27th Annual Global Investment Conference in New York on September 10, 2025, at 12:30 p.m. Eastern Time. The webcast will be available on the company’s website.
Contact:
Kaytee Bock Zafereo
katherine.bock@promisneurosciences.com
Source: ProMIS Neurosciences Inc.
