Drugs / VY-AADC02
VY-AADC02
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | Parkinson disease | 2020-12-22 | “the U.S. Food and Drug Administration (FDA) has notified Neurocrine Biosciences (Nasdaq: NBIX) that it has placed a clinical hold” voyagertherapeutics.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT03562494 | Oct 2018 → Oct 2024 | Parkinson disease | Neurocrine Biosciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-09-11 | Neurocrine Biosciences | Results Neurocrine Biosciences and Voyager Therapeutics Present New Long-Term Three-Year Data Demonstrating that One-Time Treatment with an Investigational Gene Therapy Showed Sustained Improvement in Motor Function in Patients with Parkinson's Disease gcs-web.com ↗
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) and Voyager Therapeutics, Inc. (Nasdaq: VYGR) today announced data from PD-1101, a Phase Ib open-label, three-year efficacy and safety study, demonstrating that a one-time treatment with investigational gene therapy, NBIb-1817 (VY-AADC), showed sustained improvement in motor function including greater "On" time without troublesome dyskinesia, reduction in Unified Parkinson's Disease Rating Scale (UPDRS) Part III scores, and reduction in the amount of medications in patients with Parkinson's disease. |
| 2020-09-11 | Voyager Therapeutics | Results Neurocrine Biosciences and Voyager Therapeutics Present New Long-Term Three-Year Data Demonstrating that One-Time Treatment with an Investigational Gene Therapy Showed Sustained Improvement in Motor Function in Patients with Parkinson’s Disease voyagertherapeutics.com ↗ |
All press releases naming this drug 4 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VY-AADC02 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03562494 ↗ |
| Known as | AAV2-hAADC | “Adeno-associated viral vector serotype 2 encoding human aromatic L-amino acid decarboxylase (AAV2- hAADC) infusion into the brain” NCT03562494 ↗ |
| Known as | NBIb-1817 | “VY-AADC02 (NBIb-1817)” NCT03562494 ↗ |
| Modality | Gene therapy (AAV / viral vector) | “Adeno-associated viral vector serotype 2 encoding human aromatic L-amino acid decarboxylase” NCT03562494 ↗ |
| Route | Other | “infusion into the brain” NCT03562494 ↗ |