Drugs / AVB-101
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06064890 | Aug 2023 → Apr 2026 overdue | GRN-related frontotemporal lobar degeneration with Tdp43 inclusions | AviadoBio Ltd | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-03-31 | AviadoBio Ltd | Results AviadoBio Advances AVB-101 Gene Therapy Program and Initiates Fourth Dose-Escalation Cohort of Phase 1/2 ASPIRE-FTD Trial aviadobio.com ↗
Early biomarker and safety data show encouraging signals with plans to present additional data in 2H 2026 |
| 2023-11-06 | AviadoBio Ltd | Regulatory AviadoBio Announces FDA IND Clearance and Fast Track Designation for AVB-101 for the Treatment of Frontotemporal Dementia with Progranulin (GRN) Mutations aviadobio.com ↗ |
| 2023-10-24 | AviadoBio Ltd | Results AviadoBio Announces Presentation of Promising Preclinical Safety and Biodistribution Data of its Gene Therapy Candidate AVB-101 for FTD-GRN at the Annual European Society of Gene and Cell Therapy Congress aviadobio.com ↗
At all doses studied, AVB-101 showed good tolerability and widespread PGRN expression in the brain tissues of non-human primates at three and six-months post-treatment. |
| 2022-05-17 | AviadoBio Ltd | Results AviadoBio Presents Preclinical Data at ASGCT 2022 Demonstrating that AVB-101 Represents a Novel and Promising Approach to Treatment of Frontotemporal Dementia aviadobio.com ↗
In pre-clinical pharmacology studies, AVB-101 administration via intrathalamic injection, in a progranulin-deficient mouse model, demonstrated neuronal specific PGRN brain expression and reduction in disease pathology. |
| 2022-05-04 | AviadoBio Ltd | Results AviadoBio to Present Pre-clinical Data on its Gene Therapy Candidate for Frontotemporal Dementia at ASGCT 2022 aviadobio.com ↗ |
| 2022-04-27 | AviadoBio Ltd | Regulatory AviadoBio’s Gene Therapy Candidate Receives Orphan Designation from Food and Drug Administration and European Commission in Frontotemporal Dementia aviadobio.com ↗
AviadoBio, a pioneering, pre-clinical stage, gene therapy company focused on developing and delivering transformative medicines for people with neurodegenerative disorders, announced today that both the U.S. Food and Drug Administration (FDA) and the European Commission (EC) have granted orphan designation to AVB-101, a one-time gene therapy for the treatment of frontotemporal dementia (FTD). |
All press releases naming this drug 11 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AVB-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06064890 ↗ |
| Action | Restore | “AVB-101 has been modified to contain a copy of the correct (non-mutated) GRN gene” NCT06064890 ↗ |
| Route | Other | “AVB-101 Administered by Bilateral Intrathalamic Infusion” NCT06064890 ↗ |
| Target | GRN | “AVB-101 has been modified to contain a copy of the correct (non-mutated) GRN gene” NCT06064890 ↗ |