Drugs / AFTX-201
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT07426419 | Jun 2026 → Dec 2028 expected | familial isolated dilated cardiomyopathy | Affinia Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-07-22 | Affinia Therapeutics | Regulatory FDA Grants Orphan Drug Designation to Affinia Therapeutics’ AFTX-201 for the Treatment of BAG3-Associated Dilated Cardiomyopathy (DCM) affiniatx.com ↗
Affinia Therapeutics (“Affinia”), an innovative clinical-stage gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for AFTX-201 for the treatment of BAG3-associated dilated cardiomyopathy (DCM). |
| 2026-05-14 | Affinia Therapeutics | Results ASGCT 2026: AFTX-201: A Novel Investigational AAV Gene Therapy for the Treatment of BAG3-Associated Dilated Cardiomyopathy affiniatx.com ↗
Engineered ATC-187 capsid was selected for AFTX-201 based on superior cardiomyocyte transduction vs. AAV9 |
| 2026-05-14 | Affinia Therapeutics | Results ASGCT 2026: Development, Technology Transfer, and Qualification of Product-Specific Methods for AFTX-201, an Investigational New Medicine for the Treatment of BAG3-Associated Dilated Cardiomyopathy affiniatx.com ↗
This analytical panel provides a high-resolution assessment of AAV product quality, strengthening lot-to-lot comparability and enabling informed decision-making across process development and clinical product manufacturing. |
| 2026-05-14 | Affinia Therapeutics | Results Affinia Therapeutics Presents AFTX-201 Data and UPBEAT© Clinical Trial Design for BAG3-Associated Dilated Cardiomyopathy, Alongside Advances in BBB-Penetrant AAV Capsids and Proprietary Manufacturing, at the 29th ASGCT 2026 Annual Meeting affiniatx.com ↗
This research was presented in several oral and poster sessions at the 29 th American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting, being held May 11-15, 2026 in Boston, MA, and virtually. |
| 2026-04-06 | Affinia Therapeutics | Regulatory Affinia Therapeutics Receives Approval from Health Canada to Initiate the UPBEAT© Trial, a Phase 1/2 Clinical Trial to Investigate AFTX-201 as a Treatment for BAG3-Associated Dilated Cardiomyopathy (DCM) affiniatx.com ↗
today announced the approval of its clinical trial application (CTA) by Health Canada for AFTX-201, a potential best-in-class investigational genetic medicine for the treatment of BAG3-associated dilated cardiomyopathy (DCM). |
| 2026-03-04 | Affinia Therapeutics | Regulatory Affinia Therapeutics Granted FDA Fast Track Designation for AFTX-201 as a Treatment for People Living with BAG3-Associated Dilated Cardiomyopathy (DCM) affiniatx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for AFTX-201, a potential best-in-class investigational genetic medicine for the treatment of BAG3-associated dilated cardiomyopathy (DCM) . |
| 2026-02-18 | Affinia Therapeutics | Regulatory Affinia Therapeutics Receives European Medicines Agency Orphan Drug Designation for AFTX-201 in BAG3-Associated Dilated Cardiomyopathy (DCM) affiniatx.com ↗ |
| 2026-02-04 | Affinia Therapeutics | Regulatory Affinia Therapeutics Announces FDA Acceptance of IND Application to Advance AFTX-201 to a Phase 1/2 Trial for the Treatment of BAG3-Associated Dilated Cardiomyopathy (DCM) affiniatx.com ↗ |
| 2025-05-19 | Affinia Therapeutics | Results ASGCT 2025: A Novel Investigational AAV Gene Therapy for Treatment of BAG3 Dilated Cardiomyopathy affiniatx.com ↗
AAV-BAG3 improves cardiac function in MI mice |
| 2025-05-13 | Affinia Therapeutics | Results Affinia Therapeutics Presents New Data on its Lead AFTX-201 Program in BAG3 Dilated Cardiomyopathy, BBB-Penetrant AAV Capsids, and Proprietary Manufacturing Technology at the 28th American Society of Gene & Cell Therapy 2025 Annual Meeting affiniatx.com ↗
Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies for devastating cardiovascular and neurological diseases, today announced the presentation of new preclinical data on AFTX-201, its lead program for BAG3 dilated cardiomyopathy (DCM), as well as its novel AAV capsids for diseases of the central nervous system (CNS), and the company’s high-yield manufacturing process. |
| 2024-10-22 | Affinia Therapeutics | Results Affinia Therapeutics to Highlight New Data on Genetic Cardiomyopathy Programs and BBB-Penetrant Capsids Leveraging Novel Receptors at the European Society of Gene & Cell Therapy 2024 31st Annual Congress affiniatx.com ↗
AFTX-201, Affinia’s gene therapy program in BAG3 dilated cardiomyopathy, demonstrates efficacy, safety, and differentiation in a genetically relevant preclinical model, with full restoration of cardiac function |
All press releases naming this drug 16 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AFTX-201 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07426419 ↗ |
| Route | Intravenous | “It is administered as a single intravenous infusion” NCT07426419 ↗ |