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PMN310

Phase 1

Alzheimer Disease, Early Onset | Small molecule | Neurology |ProMIS Neurosciences Inc.|Last Updated: Dec 24, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment144
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06750432PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)PHASE1 ACTIVE NOT_RECRUITING 144Dec 13, 2024Dec 1, 2026Dec 24, 202522 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310
Up to Day 365

Number and severity of adverse events

Biomarker response to PMN310 following repeat intravenous infusions of PMN310
Up to Day 365

Mean change in plasma p-tau217 in response to repeat intravenous infusions of PMN310

Secondary Endpoints
Pk profile of PMN310 with repeat dosing
Up to Day 365
Assessment of the immunogenicity of PMN310 following repeat intravenous infusions
Up to Day 365
Assessment of biomarker response to PMN310
Up to Day 365
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1 PMN310 350 mg or placeboEXPERIMENTALPMN310 350 mg or placebo administered as a 60-minute infusion.
Cohort 2 PMN310 700 mg or placeboEXPERIMENTALPMN310 700 mg or placebo administered as a 60-minute infusion.
Cohort 3 PMN310 1400 mg or placeboEXPERIMENTALPMN310 1400 mg or placebo administered as a 60-minute infusion.
Interventions
NameTypeDescription
PMN310DRUGA humanized immunoglobulin G1 (IgG1) monoclonal antibody
PlaceboDRUG0.9% NaCl 100 mL
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: 1. Patient and caregiver provide written informed consent. 2. Ambulatory male or female ≥ 50 years of age with adequate visual and auditory abilities to perform the cognitive and functional assessments in the opinion of the Investigator. 3. Meets all of the following clinical cr...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06750432primaryCompletionDate: changed
LOWMay 24, 2026NCT06750432studyFirstPostDate: changed