Clinical TrialJul 28, 2026, 06:11 AM
ProMIS Neurosciences PMN310 Phase 1b AD Trial: No ARIA-E, Positive Data
AI Summary
ProMIS Neurosciences announced positive blinded six-month interim safety and biomarker data for its lead drug candidate, PMN310, in the PRECISE-AD Phase 1b Alzheimer’s Disease trial. The data showed a favorable safety profile with no cases of amyloid-related imaging abnormalities-edema (ARIA-E) across all genotypes, including high-risk APOE4 carriers. Early, directionally consistent movement in disease-relevant biomarkers, including reductions in plasma pTau217 and CSF MTBR-tau243, was also observed. The company expects topline 12-month results in the first quarter of 2027.
Key Highlights
- PMN310 showed a favorable safety profile with 0.0% ARIA-E in 136 AD patients.
- Total ARIA was 4.4%, consisting only of mild, asymptomatic ARIA-H.
- No ARIA-E was observed in any genotype, including 61% APOE4 carriers (11% homozygotes).
- 68.5% of patients showed a decline in plasma pTau217 from baseline.
- 62.5% of patients showed a decline in CSF MTBR-tau243 from baseline.
- Topline 12-month results from the PRECISE-AD Phase 1b trial are expected in Q1 2027.
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