FDA Grants Orphan Drug Designation to Affinia Therapeutics’ AFTX-201 for the Treatment of BAG3-Associated Dilated Cardiomyopathy (DCM)

FDA Grants Orphan Drug Designation to Affinia Therapeutics’ AFTX-201 for the Treatment of BAG3-Associated Dilated Cardiomyopathy (DCM)

AFTX-201 is a potential best-in-class investigational genetic medicine given as a simple one-time IV infusion designed to address the underlying mutation responsible for BAG3 DCM

AFTX-201 is being evaluated as a treatment for BAG3-associated DCM in the UPBEAT© clinical trial actively recruiting at multiple sites in the U.S. and Canada

BAG3 DCM leads to early onset progressive heart failure, impaired quality of life, and reduced survival, despite current treatments

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).