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)

AFTX-201 uses Affinia’s proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than doses of gene therapies using conventional capsids

Company on track to initiate the UPBEAT^© clinical trial to investigate safety, pharmacodynamics, and preliminary efficacy of AFTX-201 in BAG3 DCM in the first half of 2026

Excerpt from the Press Release:

WALTHAM, Mass. – February 4, 2026 – 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 initially for devastating cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AFTX-201, an investigational genetic medicine for the treatment of BAG3 DCM.

“We are grateful to the FDA for the timely review of our IND application for AFTX-201 for the treatment of BAG3-associated dilated cardiomyopathy and to the patient and clinician community who have provided valuable input and support for our investigational program to-date,” said Hideo Makimura, M.D., Ph.D., Chief Medical Officer at Affinia. “We look forward to initiating the UPBEAT^© clinical trial at multiple trial sites in the coming weeks and bringing a much-needed treatment option for patients and families affected by this devastating disease.”

The UPBEAT^© clinical trial is a multicenter, open-label Phase 1/2 clinical trial designed to evaluate the safety, tolerability, pharmacodynamics, and preliminary efficacy of AFTX-201 in adults with genetically confirmed BAG3-associated dilated cardiomyopathy.

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