ProMIS's PMN310 heads toward 2027 readout after full, on-time AD enrollment
PRECISE-AD finished enrolling 144 Alzheimer's patients on schedule with no treatment-related serious adverse events, setting up 12-month biomarker and safety data against a field where amyloid antibodies carry a real ARIA burden.
Executive Summary
- ProMIS Neurosciences finished enrolling its Phase 1 Alzheimer's trial on schedule and above its original target, with the independent monitoring board clearing the highest planned dose.
- More than a year into dosing, the trial has not reported treatment-related serious adverse events, a result the company is positioning against the ARIA problem that has dogged approved plaque-binding amyloid antibodies.
- The company has said it wants to skip a conventional Phase 2 and move directly into a single registrational study, which raises the bar on what the coming biomarker and safety data need to show.
- The trial sits in a Phase 3-heavy amyloid-beta field with several molecules already testing the same target through late-stage trials, meaning PMN310's differentiation rests on tolerability rather than being first to market.
The trial
PRECISE-AD (NCT06750432) enrolled 144 patients with mild cognitive impairment or mild Alzheimer's disease across three intravenous dosing cohorts, finishing in December 2025 above its original 128-patient target. The study tests PMN310, a humanized IgG1 antibody directed at toxic amyloid-beta oligomers rather than amyloid plaque, against placebo. Its four registered primary endpoints cover biomarker response and safety and tolerability following repeat infusions, not a cognitive or functional efficacy measure. NCT06750432+1PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)NCT06750432ProMIS Neurosciences Announces Full Year 2025 Financial Results and Provides Corporate HighlightsMar 25, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What's been disclosed so far
ProMIS said in a March 25, 2026 shareholder update that PMN310 "continues to demonstrate a favorable safety profile, with no treatment-related serious adverse events reported to date" after more than 12 months of dosing. An independent data safety monitoring board cleared advancement to the highest planned dose, and the company said a blinded six-month interim analysis of safety and biomarker data is expected in the third quarter of 2026, ahead of the 12-month top-line readout anticipated in early 2027. No primary endpoint results have posted to ClinicalTrials.gov. ProMIS+1ProMIS Neurosciences Announces Full Year 2025 Financial Results and Provides Corporate HighlightsMar 25, 2026PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)NCT06750432
The design behind the readout
Chief Executive Officer Neil Warma said the company's goal, "subject to the results of the PRECISE-AD Phase 1b trial and feedback from the United States Food and Drug Administration," is to "advance directly into a single registrational study". PMN310 received FDA Fast Track designation in July 2025, a status that allows more frequent agency interaction but does not itself signal an approval outcome. The trial's registered enrollment count rose from 128 to 144 and its primary completion date moved from July 2026 to December 2026 in a December 2025 registry update alongside the status change to Active, not recruiting, changes that align with the completed-enrollment milestone the company had already flagged. ProMIS+1ProMIS Neurosciences Announces Full Year 2025 Financial Results and Provides Corporate HighlightsMar 25, 2026PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)NCT06750432
The competitive bar
PMN310 sits in an amyloid-beta field where several antibodies already carry Phase 3 status: lecanemab (Eisai), remternetug (Eli Lilly), trontinemab (Roche), and the vaccine candidate ACI-24.060 (AC Immune) all target amyloid-beta in Alzheimer's disease. Those programs establish that amyloid-beta engagement can produce measurable biomarker and clinical effects; PMN310's differentiation case rests on its plaque-avoiding, oligomer-selective binding, which the company argues should reduce the incidence of amyloid-related imaging abnormalities that have shadowed plaque-binding antibodies. Given that established mechanism, a biomarker response comparable to the approved class, paired with a continued absence of treatment-related serious adverse events across the full 144-patient cohort, is the combination that would support moving directly to a registrational study without an intermediate efficacy trial. ProMISProMIS Neurosciences Announces Full Year 2025 Financial Results and Provides Corporate HighlightsMar 25, 2026
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.