ProMIS Neurosciences reported that its independent Data and Safety Monitoring Board (DSMB) has unanimously approved progression to the third and final dose escalation cohort in its ongoing PRECISE-AD Phase 1b clinical trial of PMN310 for Alzheimer’s disease, the company said. Cohort 2 has been fully enrolled, and dosing has now begun in Cohort 3, according to the company.
No instances of amyloid-related imaging abnormalities (ARIA) have been observed to date, the company added. The trial is designed to enroll approximately 128 patients and remains on track to deliver interim six-month data in the second quarter of 2026 and final 12-month top-line results in the fourth quarter of 2026.
The DSMB’s recommendation is based on cumulative safety data across cohorts, allowing the trial to escalate from the 10 mg/kg dose used in Cohort 2 to the planned 20 mg/kg dose in the final cohort, the company claims.
PMN310 is described as a humanized IgG1 antibody engineered to selectively target toxic amyloid-beta oligomers, while avoiding plaque, which the company says may reduce safety concerns associated with other amyloid-directed therapies.
ProMIS Neurosciences will present further updates, including clinical progress, at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025.
