ProMIS Neurosciences announced positive blinded six-month interim safety and biomarker data from its PRECISE-AD Phase 1b clinical trial evaluating PMN310 in patients with early Alzheimer's disease. The analysis showed a favorable safety profile, highlighted by the absence of ARIA-E, a serious side effect associated with other amyloid-directed therapies.
Key Details
- Safety Results: In the 136-patient analysis, there were no cases of amyloid-related imaging abnormalities-edema (ARIA-E). The total ARIA rate was 4.4%, consisting only of mild, asymptomatic microhemorrhages (ARIA-H).
- Biomarker Trends: Blinded data showed favorable trends against expected disease progression, with 68.5% of patients showing a decline in plasma pTau217 and 62.5% showing a decline in CSF MTBR-tau243, suggesting potential target engagement.
- Next Milestone: The trial remains blinded and ongoing, with 12-month topline results, including unblinded efficacy data, expected in the first quarter of 2027.