ProMIS Neurosciences has received DSMB approval to advance to the final dose escalation cohort in the Phase 1b Alzheimer's trial of PMN310.
Enrollment and dosing for Cohort 3, the final dose level, are now underway after Cohort 2 was fully enrolled.
No cases of amyloid-related imaging abnormalities (ARIA) have been observed to date.
The trial aims to enroll 128 patients and is on track to report 6-month interim data in Q2 2026 and final 12-month top-line results in Q4 2026.
DSMB Approval for Final Dose Escalation
The independent DSMB recommended proceeding to the third and final dose escalation cohort, indicating positive safety data up to Cohort 2 without ARIA cases.
Unique Therapeutic Approach
PMN310 targets toxic oligomers instead of amyloid plaques, potentially reducing safety concerns and focusing on disease progression.
Clinical Development Progress
Advancement to the final dose level and scheduled interim and final data readouts in 2026 demonstrate steady progress in ProMIS Neurosciences' Phase 1b program.
- The positive safety profile observed with PMN310 reinforces its selective design and potential to address critical unmet needs in Alzheimer's disease.
- The DSMB's recommendation for dose escalation indicates confidence in the therapeutic approach and progress of the clinical trial.
- Future assessments of biomarkers and target engagement will provide valuable insights into the therapeutic effects and disease modification potential of PMN310.
The DSMB approval for final dose escalation marks a significant milestone for ProMIS Neurosciences' Alzheimer's trial, highlighting the promising safety profile and progress of PMN310.