Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ponezumab · 1 trial · 1 indication
Blood Oxygen Level Dependant (BOLD) fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using Arterial Spin Labeled (ASL) scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and standard errors (SE) are presented in logarithmic (log e) scale.
BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and SEs are presented in log e scale.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ponezumab | BIOLOGICAL | Infusion of Ponezumab (Day 1=10mg/kg; Day 30 and Day 60 dose = 7.5mg/kg) or placebo (saline); administered via infusion for a total infusion time of 20 minutes. |
| placebo | OTHER | placebo (saline)- given via infusion total infusion time of 20 minutes |
Inclusion Criteria: * Patients diagnosed with probable CAA using the Boston criteria; with no clinical cognitive impairment * In general good health Exclusion Criteria: * Co-morbid diagnosis of clinically documented Alzheimer's disease or significant cognitive impairment * Clinically significant ...
Ponezumab was developed for cerebral amyloid angiopathy, a neurological condition in which amyloid protein deposits build up in the blood vessels of the brain. It was studied in adults with probable cerebral amyloid angiopathy, a patient population aged 55 years and older. It is an investigational therapy and is not an approved treatment.
Ponezumab targets amyloid precursor protein, or APP. It is a monoclonal antibody designed to bind APP, the protein from which amyloid beta peptides are derived. Because cerebral amyloid angiopathy involves amyloid deposition in cerebral blood vessels, targeting APP was the intended approach for this antibody in that condition.
Ponezumab was developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical research program for the antibody, including the Phase 2 study conducted in patients with probable cerebral amyloid angiopathy across sites in the United States, Canada, France, the Netherlands, and the United Kingdom.
Ponezumab reached Phase 2 clinical development for cerebral amyloid angiopathy. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. The Phase 2 program has been completed, and no trials of this agent are currently listed as active.
Ponezumab was studied in one completed Phase 2 trial, NCT01821118, titled a study evaluating the safety, tolerability, and efficacy of PF-04360365 in adults with probable cerebral amyloid angiopathy. That randomized, double-blind, placebo-controlled trial enrolled 36 participants aged 55 years and older across five countries.
Yes. PF-04360365 is the Pfizer compound code for Ponezumab, and the two names refer to the same monoclonal antibody. The Phase 2 trial in cerebral amyloid angiopathy, NCT01821118, is listed under the PF-04360365 designation, while Ponezumab is the international nonproprietary name for the same agent.