Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AAV2-GDNF gene therapy
AB-1005 · 2 trials · 1 indication
Number and proportion of participants with at least one adverse event
Normalized Good ON time per Hauser Diary
| Arm | Type | Description |
|---|---|---|
| AB-1005 infusion | EXPERIMENTAL | - |
| AAV2-GDNF | EXPERIMENTAL | - |
| Control Surgery | SHAM_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AB-1005 | DRUG | Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose |
| AAV2-GDNF gene therapy | DRUG | Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose |
| control surgery | PROCEDURE | Bilateral partial burr/twist holes without dural penetration |
Inclusion Criteria: * Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent * Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) and currently meeting all the following criteria: 1. Presence of bradykinesia PLUS any of the following: r...
Top 15 of 23 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 2 | PHASE3 | Onapgo (SPN-830) |
| Prothena Corp. Plc | PRTA | 3 | PHASE3 | Prasinezumab |
| Denali Therapeutics Inc. | DNLI | 1 | PHASE2 | BIIB122 |
| Bayer | BAYRY | 4 | PHASE3 | bemdaneprocel, AB-1005 |
| Biohaven Ltd. | BHVN | 1 | PHASE2 | BHV-8000 |
| AC Immune SA | ACIU | 2 | PHASE2 | ACI-7104.056 |
| Eli Lilly and Company | LLY | 4 | PHASE1 | LY3884961, LY4006896, LY3962681 |
| Gain Therapeutics, Inc. | GANX | 2 | PHASE2 | GT-02287 |
| Annovis Bio Inc | ANVS | 1 | PHASE2 | Buntanetap |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | ALN-SNCA |
| MeiraGTx Holdings Plc | MGTX | 1 | PHASE1 | AAV-GAD |
| Serina Therapeutics, Inc. | SER | 1 | PHASE1 | SER-252 |
| Ardelyx, Inc. | ARDX | 1 | PHASE2 | Tenapanor |
| Hoffmann-La Roche | RHHBY | 1 | PHASE1 | RO7568282 |
| Merck & Co., Inc. | MRK | 1 | EARLY_PHASE1 | MK-0947 |
AB-1005 is an investigational gene therapy being developed for Parkinson disease. It is also known as AAV2-GDNF gene therapy. It is currently in Phase 2 clinical development and is being studied in adults with moderate Parkinson disease. It has not been approved by any regulatory agency.
AB-1005 is being studied as a treatment for moderate Parkinson disease in adults aged 45 years and older. The Phase 2 program is evaluating it in patients with moderate disease. It is investigational and has not been approved for any indication.
AB-1005 is being developed by Bayer AG, which trades under the ticker BAYRY. Bayer is running the Phase 2 clinical program for the gene therapy in Parkinson disease across multiple countries.
AB-1005 is in Phase 2 clinical development. Two Phase 2 trials are active, and no trials have been completed. The program has enrolled a total of 135 planned participants across the two studies. AB-1005 is investigational and has not received regulatory approval.
AB-1005 is being tested in two Phase 2 trials. NCT06285643, also called REGENERATE-PD, is recruiting 127 adults with moderate Parkinson disease in the United States, Germany, Poland, and the United Kingdom. NCT07566429, called J-REGENERATE-PD, is not yet recruiting 8 adults in Japan.
Yes, AB-1005 is also known as AAV2-GDNF gene therapy. Both names refer to the same investigational product being developed by Bayer AG for moderate Parkinson disease in Phase 2 trials. Searches for either name point to the same clinical program.