Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PMN310 · 2 trials · 2 indications
Number and severity of adverse events
Mean change in plasma p-tau217 in response to repeat intravenous infusions of PMN310
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 PMN310 350 mg or placebo | EXPERIMENTAL | PMN310 350 mg or placebo administered as a 60-minute infusion. |
| Cohort 2 PMN310 700 mg or placebo | EXPERIMENTAL | PMN310 700 mg or placebo administered as a 60-minute infusion. |
| Cohort 3 PMN310 1400 mg or placebo | EXPERIMENTAL | PMN310 1400 mg or placebo administered as a 60-minute infusion. |
| Cohort 1 PMN310 175mg or placebo | EXPERIMENTAL | PMN310 175mg or placebo administered as a 60-minute infusion. |
| Cohort 2 PMN310 350mg or placebo | EXPERIMENTAL | PMN310 350mg or placebo administered as a 60-minute infusion. |
| Cohort 3 PMN310 700mg or placebo | EXPERIMENTAL | PMN310 700mg or placebo administered as a 60-minute infusion. |
| Cohort 4 PMN310 1400mg or placebo | EXPERIMENTAL | PMN310 1400mg or placebo administered as a 60-minute infusion. |
| Cohort 5 PMN310 2800mg or placebo | EXPERIMENTAL | PMN310 2800mg or placebo administered as a 60-minute infusion. |
| Name | Type | Description |
|---|---|---|
| PMN310 | DRUG | A humanized immunoglobulin G1 (IgG1) monoclonal antibody |
| Placebo | DRUG | 0.9% NaCl 100 mL |
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...
PMN310 is an investigational small molecule being developed for early Alzheimer's disease. It is designed to target amyloid-beta oligomers, which are toxic protein clumps implicated in Alzheimer's pathology. The drug is currently in Phase 1 clinical trials, including a study in patients with early-onset Alzheimer's disease and a completed study in healthy volunteers.
PMN310 targets amyloid-beta oligomers, which are small, soluble aggregates of the amyloid-beta protein that are believed to contribute to neuronal damage in Alzheimer's disease. By binding to these oligomers, PMN310 aims to neutralize their toxic effects. This mechanism is being investigated in early-stage clinical trials for Alzheimer's disease.
PMN310 is being developed by ProMIS Neurosciences Inc., a biopharmaceutical company focused on neurodegenerative diseases. ProMIS Neurosciences is publicly traded under the ticker symbol PMN. The company is conducting clinical trials to evaluate PMN310 as a potential treatment for early Alzheimer's disease.
PMN310 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Two Phase 1 trials have been conducted: one completed study in healthy volunteers and an ongoing study in patients with early Alzheimer's disease. The drug has received Fast Track designation from the FDA.
PMN310 is being evaluated in two Phase 1 clinical trials. NCT06750432, titled 'PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)', is active but not recruiting, with 144 participants in the United States. NCT06105528, a Phase 1a study in healthy volunteers, has been completed with 40 participants.
PMN310 is a distinct investigational small molecule developed by ProMIS Neurosciences. It specifically targets amyloid-beta oligomers, a different mechanism compared to some approved antibody therapies that target amyloid plaques. As a small molecule, it may offer advantages in terms of delivery and brain penetration, though it is still in early clinical development.