Affinia Therapeutics Receives Approval from Health Canada to Initiate UPBEAT Trial for BAG3-Associated Dilated Cardiomyopathy

The Phase 1/2 clinical trial will investigate AFTX-201, a potential best-in-class gene therapy for the treatment of BAG3 DCM.

Apr. 6, 2026 at 1:54pm

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Affinia Therapeutics, an innovative gene therapy company, has received approval from Health Canada to initiate the UPBEAT clinical trial, a Phase 1/2 study investigating AFTX-201 as a treatment for BAG3-associated dilated cardiomyopathy (DCM). AFTX-201 is designed to deliver a fully human, full-length BAG3 transgene using Affinia's proprietary capsid engineered for efficient cardiac transduction at lower doses compared to conventional gene therapies.

Why it matters

BAG3 DCM is a serious, inherited heart condition with a high mortality rate and a significant unmet medical need. The disease leads to early onset, progressive heart failure, and premature death, and there is currently no treatment that targets the underlying genetic mechanism of the disease. The approval of the UPBEAT trial is a significant milestone in the development of a potential transformative treatment for patients living with BAG3 DCM.

The details

The UPBEAT trial is a multicenter, single-arm 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. The trial includes a dose-exploration phase followed by a dose-expansion phase, and all participants will receive a single intravenous infusion of AFTX-201. The primary objective is to evaluate safety and tolerability through 52 weeks, with secondary and exploratory objectives including pharmacodynamic and preliminary efficacy assessments.

  • The CTA approval from Health Canada follows recent advances in the clinical development of AFTX-201, including the acceptance of Affinia's Investigational New Drug (IND) application by the U.S. FDA and the granting of Fast Track designation.
  • Affinia is working to begin patient enrollment and dosing in the UPBEAT trial in the next few weeks.

The players

Affinia Therapeutics

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 diseases.

AFTX-201

Affinia's investigational genetic medicine designed to deliver a fully human, full-length BAG3 transgene using a proprietary capsid engineered for efficient cardiac transduction at lower doses.

Rafik Tadros, M.D., Ph.D.

Canadian Research Chair in Translational Cardiovascular Genetics, Director of the Cardiovascular Genetics Centre at the Montréal Heart Institute, and the Philippa and Marvin Carsley Chair in Cardiovascular Genetics and Associate Professor at the University of Montréal.

Hideo Makimura, M.D., Ph.D.

Chief Medical Officer at Affinia Therapeutics.

Health Canada

The regulatory authority that approved Affinia's clinical trial application for the UPBEAT trial.

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What they’re saying

“BAG3 DCM is a serious, inherited heart condition with a high mortality and a large unmet medical need. It leads to early onset, progressive heart failure, and premature death and there is no treatment that exists which targets the underlying mechanism of disease. We applaud Affinia for developing promising therapies such as AFTX-201 that address the genetic root cause of BAG3 DCM.”

— Rafik Tadros, Canadian Research Chair in Translational Cardiovascular Genetics, Director of the Cardiovascular Genetics Centre at the Montréal Heart Institute, and the Philippa and Marvin Carsley Chair in Cardiovascular Genetics and Associate Professor at the University of Montréal

“The approval of our CTA in Canada for AFTX-201 is another significant clinical milestone, following the FDA's recent acceptance of our IND application and granting of the Fast Track designation for AFTX-201. We are working diligently with multiple trial sites and investigators across the U.S. and Canada to begin patient enrollment and dosing in the next few weeks in the UPBEAT clinical trial so that we can bring this potentially transformative treatment to patients living with BAG3 DCM and make a meaningful impact in their lives.”

— Hideo Makimura, Chief Medical Officer at Affinia Therapeutics

What’s next

Affinia Therapeutics is working to begin patient enrollment and dosing in the UPBEAT clinical trial in the next few weeks.

The takeaway

The approval of the UPBEAT trial by Health Canada represents a significant milestone in the development of a potential transformative treatment for patients living with the serious and life-threatening BAG3-associated dilated cardiomyopathy. If successful, AFTX-201 could address the underlying genetic cause of this devastating disease and provide hope for those affected.