Data Readout

ProMIS's PMN310 clears to top dose in Alzheimer's trial with no drug-related SAEs so far

PRECISE-AD has finished enrolling 144 patients and cleared its safety board to the highest planned dose, setting up a Q3 2026 interim analysis ahead of full topline data.

By AppliedXLJuly 13, 2026Trial NCT06750432

Executive Summary

ProMIS Neurosciences has finished enrolling its Phase 1b trial of PMN310 in early Alzheimer's disease and cleared a safety board review to move to the highest planned dose, with no treatment-related serious adverse events reported so far.
The trial's primary endpoints are biomarker response and safety and tolerability, not a clinical efficacy readout, so the coming data will speak to target engagement and tolerability rather than a disease-modifying claim.
PMN310 enters a field where multiple amyloid-beta-targeting antibodies are already in Phase 3, so its differentiation rests on its selectivity for toxic oligomers rather than plaque, a distinction the interim biomarker data could begin to test.
A blinded interim analysis is expected in the third quarter of 2026, ahead of topline results anticipated by year-end, with full 12-month data following in early 2027.

The trial

PRECISE-AD (NCT06750432) is a randomized, double-blind, placebo-controlled Phase 1b study testing PMN310, an antibody ProMIS Neurosciences designed to selectively bind toxic amyloid-beta oligomers rather than the amyloid plaque targeted by approved antibodies. The trial enrolled 144 patients with mild cognitive impairment or mild dementia due to Alzheimer's disease across three intravenous dose cohorts, 5, 10, and 20 mg/kg, dosed monthly for 12 months against placebo. Enrollment rose from a target of 128 to 144 patients between the trial's initial registration and a December 2025 update, alongside a status change to Active, not recruiting and a primary completion date shift from July 2026 to December 2026. NCT06750432

Probability of Success

Endpoint Met49%

Completes99%

Clinical Significance60%

Regulatory85%

The endpoint bar

The trial's four listed primary endpoints cover biomarker response to PMN310 and safety and tolerability following repeat infusions, not a clinical efficacy measure. Eighteen secondary endpoints include preliminary efficacy signals on ADAS-Cog14, CDR-SB, MMSE, and iADRS, along with pharmacokinetics, immunogenicity, and cortical and hippocampal volume by MRI. A Phase 1b trial of this size, built around biomarker and safety endpoints, is designed to generate a hypothesis-testing signal on tolerability and target engagement, not a decision-grade efficacy readout. NCT06750432

The safety signal so far

ProMIS said PMN310 continues to show a favorable safety profile in PRECISE-AD, with no treatment-related serious adverse events reported to date, and that its data safety monitoring board cleared the trial to advance to the highest planned 20 mg/kg dose. Frequent MRI scans are built into the protocol to monitor for ARIA, the brain swelling and microhemorrhage signal that has shaped the safety label of approved amyloid antibodies. ProMIS Chief Executive Officer Neil Warma said the Phase 1b study "was carefully designed to generate a body of clinical data, including biomarker insights and evaluation of potential efficacy and safety signals". ProMIS

The competitive field

PMN310 is not first-in-class against the amyloid-beta target: five comparators sharing the same target are already in Phase 3, including Eisai's lecanemab, Eli Lilly's remternetug, Roche's trontinemab, AC Immune's ACI-24.060, and CereMark's flornaptitril. Those programs target amyloid plaque or use bispecific and vaccine approaches; PMN310's selectivity for soluble toxic oligomers over plaque is the mechanistic distinction ProMIS is testing, a hypothesis the interim biomarker data will begin to inform rather than resolve. PMN310 received FDA Fast Track designation in July 2025, a designation tied to Alzheimer's disease as an area of unmet need rather than a signal of approval likelihood. NCT06750432

Timeline

ProMIS first guided to six-month interim results in the first half of 2026 with topline data by year-end in its March 2025 disclosure, and later guidance through December 2025 held that year-end 2026 topline target while narrowing the interim readout to the third quarter of 2026. The primary completion date on the registry moved from July 2026 to December 2026 alongside the enrollment increase, both logged in the same December 2025 registry update. ProMIS+1

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.