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AFTX-201 · 1 trial · 2 indications
Safety and tolerability of AFTX-201 over 12 months.
| Arm | Type | Description |
|---|---|---|
| AFTX-201 | EXPERIMENTAL | Participants will receive a single intravenous dose of AFTX-201 |
| Name | Type | Description |
|---|---|---|
| AFTX-201 | GENETIC | AFTX-201 is a gene therapy product consisting of the ATC-0187 capsid containing the BCL2-associated Athanogene 3 (BAG3) transgene. It is administered as a single intravenous infusion |
Inclusion Criteria: Male or female, 18 to 70 years of age Truncating mutation in BAG3 Dilated cardiomyopathy with left ventricular ejection fraction (LVEF) \< 45% NYHA Class II or III heart failure symptoms NT-proBNP ≥ 300 pg/mL for subjects in sinus rhythm or paced rhythm, or ≥ 600 pg/mL for s...
AFTX-201 is an investigational gene therapy being developed for the treatment of dilated cardiomyopathy (DCM), specifically in adults with BAG3-associated dilated cardiomyopathy. It is designed to address the underlying genetic cause of this condition, which affects the heart's ability to pump blood effectively.
AFTX-201 targets the BAG3 gene, which is associated with dilated cardiomyopathy. The therapy is designed to deliver a functional copy of the BAG3 gene to heart cells, potentially correcting the genetic defect that leads to the disease. This mechanism is being evaluated in a Phase 1 clinical trial.
AFTX-201 is being developed by cbdMD, Inc., a company publicly traded under the ticker symbol YCBD on the NYSE American. The company is conducting clinical research on this gene therapy candidate for dilated cardiomyopathy.
AFTX-201 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to evaluate the safety and preliminary efficacy of the therapy.
AFTX-201 is being studied in a Phase 1 clinical trial registered as NCT07426419. This open-label, uncontrolled trial is recruiting 22 adults aged 18 years and older with BAG3-associated dilated cardiomyopathy in the United States. The study is currently in the recruiting stage.
AFTX-201 is a gene therapy that targets the BAG3 gene, but it is not referred to by an alternative name in the available information. It is specifically designed for patients with BAG3 mutations that cause dilated cardiomyopathy, and it is being evaluated under the name AFTX-201.