Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3884963 · 1 trial · 1 indication
Measured by brain and spine MRI
PGRN: progranulin protein. Measured by level of antibodies and ELISPOT
Measured by levels of antibodies.
| Arm | Type | Description |
|---|---|---|
| Initial Cohort - Low dose | EXPERIMENTAL | - |
| Initial Cohort - Medium dose | EXPERIMENTAL | - |
| Bridging Cohort - Low dose | EXPERIMENTAL | Participants enrolled in the Bridging Cohort will be assigned to either low or medium dose in an alternating manner |
| Bridging Cohort - Medium dose | EXPERIMENTAL | Participants enrolled in the Bridging Cohort will be assigned to either low or medium dose in an alternating manner |
| Cohort 5-Medium Dose | EXPERIMENTAL | Will enroll up to 10 participants with early phase of disease |
| Name | Type | Description |
|---|---|---|
| LY3884963 | BIOLOGICAL | Participants will receive a single dose of LY3884963, administered intra cisterna magna |
| Methylprednisolone | DRUG | IV pulses every 2 weeks in the first 3 months. |
| Optional Sirolimus | DRUG | At the investigators discretion following steroid tolerability issues, patients may receive a loading dose, followed by maintenance dose, followed by dose tapering; administered as concomitant medication |
| Optional Prednisone | DRUG | If needed and at the investigator discretion, Oral Prednisone may be added to the immunosuppression regimen |
Inclusion Criteria: * Men or women aged 30 to 85 years (inclusive), at the time of informed consent. * Body weight range of ≥40 kg (88 lbs) to ≤110 kg (242 lb) and a BMI of 18 to 34 kg/m2. * Has symptomatic frontotemporal dementia (FTD), including mild behavioral, cognitive, motor or language impai...
LY3884963 is an investigational monoclonal antibody being developed for frontotemporal dementia, specifically in patients with progranulin mutations (FTD-GRN). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
LY3884963 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. It is being studied for its potential to treat frontotemporal dementia with progranulin mutations.
LY3884963 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY.
LY3884963 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. It is currently being evaluated in an active clinical trial.
LY3884963 is being studied in one active clinical trial, NCT04408625, a Phase 1/2 trial in patients with frontotemporal dementia with progranulin mutations. The trial is enrolling 35 participants across the United States, Australia, Belgium, France, Spain, and the United Kingdom.