Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NEOD001 · 2 trials · 2 indications
N-terminal pro-brain natriuretic peptide (NT-proBNP ) best response (Response or Non-Response \[Stable, Progression\]) from baseline through 12 months of treatment. Cardiac best response, as assessed by NT-proBNP alone, is defined as the most favorable category among response (ie, decrease in NT-proBNP from baseline of \>30% and \>300 ng/L), stable (ie, neither response nor progression), and progression (ie, increase in NT-proBNP from baseline of \>30% and \>300 ng/L) across all visits after the first infusion of study drug up to and through the end of the study. Subjects are considered non-responders until a response is achieved. Non-response is defined as either stable or progression.
* Adverse event profile * Dose limiting toxicity and maximum tolerated dose
* Adverse event profile * Dose Limiting Toxicity and maximum tolerated dose
| Arm | Type | Description |
|---|---|---|
| NEOD001 | EXPERIMENTAL | Study Drug given IV every 28 days at 24mg/kg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| NEOD001 | DRUG | NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates |
| Placebo | DRUG | Saline Bag |
Inclusion Criteria: 1. Age ≥18 years 2. Confirmed diagnosis of systemic AL amyloidosis 3. ≥1 prior systemic plasma cell dyscrasia therapy with at least a partial hematologic response 4. Cardiac involvement 5. NT-proBNP ≥650 Exclusion Criteria: 1. Non-AL amyloidosis 2. Meets the International Myel...
NEOD001 is an investigational small molecule being developed for the treatment of AL amyloidosis, also known as primary amyloidosis. It is a rare disease therapeutic that has been studied in clinical trials for this condition.
NEOD001 is being developed by Prothena Corporation plc, a biopharmaceutical company. The company's stock is traded under the ticker symbol PRTA.
NEOD001 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still in clinical development.
NEOD001 has been studied in two completed clinical trials. The first, NCT01707264, was a Phase 1/2 open-label dose escalation study in subjects with primary amyloidosis. The second, NCT02632786, was the PRONTO study, a global Phase 2b trial in previously treated subjects with AL amyloidosis.
No, NEOD001 is the drug being studied, while PRONTO is the name of a specific clinical trial, NCT02632786, which evaluated NEOD001 in patients with AL amyloidosis.