Drugs / LX2006
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05445323 | Aug 2022 → Sep 2029 expected | Friedreich ataxia, extrinsic cardiomyopathy | Lexeo Therapeutics | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-06-17 | Lexeo Therapeutics | Results Lexeo Therapeutics Announces Publication in JAMA Cardiology of Phase I/II Data for LX2006 in Friedreich Ataxia lexeotx.com ↗ |
| 2025-10-07 | Lexeo Therapeutics | Results Lexeo Therapeutics Announces Progress in FDA Discussions for Accelerated Approval Pathway and Positive Interim Clinical Data for LX2006 in Friedreich Ataxia Cardiomyopathy lexeotx.com ↗
Interim clinical data show sustained or deepening improvements in the majority of participants across both cardiac and neurologic measures of Friedreich ataxia |
| 2025-08-14 | Lexeo Therapeutics | Regulatory Lexeo Therapeutics Reports Second Quarter 2025 Financial Results and Operational Highlights lexeotx.com ↗
Breakthrough Therapy designation granted for LX2006 based on interim data from Phase I/II trials demonstrating clinically meaningful improvements in cardiac and neurologic measures of Friedreich ataxia |
| 2025-07-07 | Lexeo Therapeutics | Regulatory Lexeo Therapeutics Announces FDA Breakthrough Therapy Designation for LX2006 in Friedreich Ataxia lexeotx.com ↗
Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today announced that the U.S. Food and Drug administration (FDA) has granted Breakthrough Therapy designation to LX2006 based on clinical evidence generated on both cardiac and neurologic measures of Friedreich ataxia (FA). |
| 2025-04-07 | Lexeo Therapeutics | Results Lexeo Therapeutics Announces Positive Interim Phase 1/2 Data for LX2006 in Friedreich Ataxia Cardiomyopathy Supporting Advancement to Registrational Study lexeotx.com ↗ |
| 2024-07-15 | Lexeo Therapeutics | Results Lexeo Therapeutics Announces Positive Interim Phase 1/2 Clinical Data of LX2006 for the Treatment of Friedreich Ataxia Cardiomyopathy lexeotx.com ↗ |
| 2024-04-16 | Lexeo Therapeutics | Regulatory Lexeo Therapeutics Granted FDA Fast Track Designation for LX2006, an AAV-Based Gene Therapy Candidate for the Treatment of Friedreich’s Ataxia Cardiomyopathy lexeotx.com ↗
NEW YORK, April 16, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LX2006, the company’s AAVrh.10hFXN-based gene therapy candidate for the treatment of Friedreich’s ataxia (FA) cardiomyopathy. |
| 2024-03-11 | Lexeo Therapeutics | Results Lexeo Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights lexeotx.com ↗
Reports frataxin protein expression data from a subset of the second dose cohort of SUNRISE-FA, a Phase 1/2 clinical trial of LX2006 for the treatment of Friedreich’s ataxia (FA) cardiomyopathy, showing positive change in post-treatment frataxin levels |
| 2022-02-16 | Lexeo Therapeutics | Regulatory LEXEO Announces FDA Clearance of IND Application for LX2006 for Friedreich’s Ataxia Cardiomyopathy lexeotx.com ↗
This IND clearance represents an important milestone for LEXEO. |
| 2021-06-30 | Lexeo Therapeutics | Regulatory LEXEO Therapeutics Receives Rare Pediatric Disease & Orphan Drug Designations for LX2006 for the Treatment of Friedreich’s Ataxia lexeotx.com ↗ |
| 2021-04-28 | Lexeo Therapeutics | Results LEXEO Therapeutics Announces Upcoming Data Presentations at the American Society of Gene and Cell Therapy (ASGCT) 2021 Virtual Annual Meeting lexeotx.com ↗
These results demonstrate effective delivery of the AAVrh.10 vector to the heart. |
All press releases naming this drug 16 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LX2006 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05445323 ↗ |
| Action | Restore | “LX2006 is designed to restore hFXN levels in order to improve mitochondrial function.” NCT05445323 ↗ |
| Modality | Gene therapy (AAV / viral vector) | “an adeno-associated virus (AAV) gene therapy designed to intravenously deliver the human frataxin (hFXN) gene” NCT05445323 ↗ |
| Route | Intravenous | “AAVrh.10hFXN, administered intravenously in 3 dose cohorts” PMID 42307907 ↗ Jun 2026 |
| Target | FXN | “Adeno-associated viral vector encoding the FXN gene (AAVrh.10hFXN)” NCT05445323 ↗ |