Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3884961 · 3 trials · 4 indications
Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) with AE's graded as mild, moderate, or severe.
GCase (glucocerebrosidase)
GCase (glucocerebrosidase)
GCase (glucocerebrosidase)
GCase (glucocerebrosidase)
| Arm | Type | Description |
|---|---|---|
| LY3884961 | EXPERIMENTAL | LY3884961 is an advanced therapy investigational medicinal product administered as a single intravenous infusion. |
| Low Dose | EXPERIMENTAL | - |
| High Dose | EXPERIMENTAL | - |
| Dose Level 1 | EXPERIMENTAL | - |
| Dose Level 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| LY3884961 | GENETIC | • LY3884961 is a replication-incompetent recombinant adeno-associated virus (AAV) vector. The vector is composed of a ss DNA genome packaged in an AAV-derived protein capsid. |
| Methylprednisolone | DRUG | Single IV pulse administered as concomitant medication. |
| Sirolimus | DRUG | Loading dose, followed by maintenance doses, followed by dose tapering; administered as concomitant medication. |
| Prednisone | DRUG | Administered orally as concomitant medication, followed by dose tapering. |
Inclusion Criteria: 1. Age greater or equal to 18 years at the time of informed consent. 2. Bi-allelic pathogenic GBA1 variants must be centrally confirmed. 3. On ERT or SRT for at least 2 years and on a stable, maximum tolerated dose, for at least 3 months prior to screening. 4. Capable of giving ...
LY3884961 is an investigational gene therapy being studied for Gaucher Disease, Parkinson Disease, and Gaucher Disease Type 2. It is being evaluated in clinical trials for patients with Parkinson's disease who have at least one GBA1 mutation, as well as for infants with Type 2 Gaucher disease and adults with peripheral manifestations of Gaucher disease.
LY3884961 is being developed by Eli Lilly and Company (ticker: LLY). The company is conducting clinical trials of this gene therapy across multiple indications, including Parkinson's disease and Gaucher disease.
LY3884961 is in Phase 1 clinical development. It is an investigational gene therapy that has not been approved by regulatory authorities. The drug is currently being studied in early-stage clinical trials for Gaucher disease and Parkinson's disease.
LY3884961 is being studied in three clinical trials: NCT04127578 (PROPEL) in Parkinson's disease with GBA1 mutations, NCT04411654 (PROVIDE) in Type 2 Gaucher disease, and NCT05487599 (PROCEED) in peripheral manifestations of Gaucher disease. All trials are in Phase 1 and are active, with one still recruiting.
Yes, LY3884961 is also known as PR001. The clinical trials refer to the drug as PR001 (LY3884961), including the PROPEL, PROVIDE, and PROCEED studies. This gene therapy is being developed by Eli Lilly and Company for Gaucher disease and Parkinson's disease.