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PMN310

Phase 1

Alzheimer Disease, Early Onset | Small molecule | Neurology |ProMIS Neurosciences Inc.|Trials Updated: Jul 13, 2026

PMN310 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Oct 2023

PMN310 target and mechanism

Molecular targetamyloid-beta oligomers
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment144

FDA Designations

FAST_TRACK

PMN310 clinical trials

PMN310 · 1 trial · 1 indication

Phase 1 1
NCT06750432PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)Alzheimer Disease, Early Onset
ACTIVE NOT_RECRUITING144 Analytics
PHASE1ACTIVE NOT_RECRUITING
PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)
Alzheimer Disease, Early OnsetUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310
Up to Day 337

Number and severity of adverse events

Biomarker response to PMN310 following repeat intravenous infusions of PMN310
Up to Day 337

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 337
Assessment of the immunogenicity of PMN310 following repeat intravenous infusions
Up to Day 309
Assessment of biomarker response to PMN310
Up to Day 337
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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 to 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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Frequently asked questions about PMN310

What is PMN310?

PMN310 is an investigational small molecule being developed by ProMIS Neurosciences Inc. for early onset Alzheimer disease. It is designed to target amyloid-beta oligomers and is currently in Phase 1 clinical development. It has received Fast Track designation from the FDA.

What is PMN310 used for in early onset Alzheimer disease?

PMN310 is being studied as a treatment for early onset Alzheimer disease. It is an investigational therapy in Phase 1 testing and has not been approved for any indication. The Phase 1 trial enrolls patients aged 50 years and older with early Alzheimer disease.

What does PMN310 target?

PMN310 targets amyloid-beta oligomers. It is a small molecule designed to bind these oligomers, which are considered a toxic form of amyloid-beta in Alzheimer disease. This targeted approach distinguishes it from therapies aimed at amyloid plaques.

Who is developing PMN310?

PMN310 is being developed by ProMIS Neurosciences Inc., a biotechnology company whose common stock trades under the ticker symbol PMN. The company is advancing the drug as its lead candidate for early Alzheimer disease.

What phase is PMN310 in?

PMN310 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is active but not recruiting, and the program has received FDA Fast Track designation.

What clinical trials is PMN310 in?

PMN310 is being evaluated in the Phase 1 PRECISE-AD trial, registered as NCT06750432. The trial is titled PMN310 in Patients With Early Alzheimer's Disease and is active but not recruiting. It is a randomized, double-blind, controlled study with a planned enrollment of 144 participants in the United States.