Axon Therapies Cohort Study Extends Benefit to 6 months with Early Clinical Data from REBALANCE-HF Randomized Clinical Trial

SANTA CLARA, Calif., March 22, 2023 /PRNewswire/ -- Axon Therapies, a private company focused on addressing a root cause of heart failure, today announced positive 6-month results from a roll-in cohort for their feasibility IDE trial, REBALANCE-HF. The latest data is consistent with prior results previously presented for their proprietary Splanchnic Ablation for Volume Management (SAVM) therapy. A novel frontline therapy, the outpatient ablation procedure aims to rebalance volume distribution for heart failure patients with preserved ejection fraction (HFpEF). The company also announced it expects the REBALANCE-HF trial to reach full enrollment of approximately 120 patients by the end of March with full study results anticipated in 2024. 

"The SAVM procedure offers an exciting option to treat an underlying cause of heart failure in a patient population that currently has limited treatment options available," commented Dr. Marat Fudim, Advanced Heart Failure Specialist at Duke University Medical Center in Durham, North Carolina, who presented the results at the Technology and Heart Failure Therapeutics (THT) annual conference in Boston, Massachusetts. "Although early data, it is promising to see positive patient benefits sustained for six months and we look forward to further demonstrating how SAVM has the potential to benefit the HFpEF patient population."

Dr. Sanjiv Shah, a renowned expert in treating patients with HFpEF and National Principal Investigator for the REBALANCE-HF trial, added, "HFpEF encompasses several distinct phenotypes, and recent studies have indicated that this diversity may impact clinical outcomes. For that reason, we opted for a larger feasibility trial to identify potential responder groups at an earlier stage. As we continue to collect follow-up data for the REBALANCE-HF feasibility trial, this information will help guide the final pivotal trial design." Dr. Shah is an Advanced Heart Failure Specialist and the Director of Research for the Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

Designed to evaluate the safety and efficacy of the SAVM procedure in HFpEF patients, REBALANCE HF is the largest randomized controlled feasibility trial in patients with HFpEF. The primary endpoints of the prospective, multi-center trial include clinical improvements in pulmonary capillary wedge pressure (PCWP) with exercise and patient quality of life metrics. The study roll-in cohort for this early analysis includes 26 patients who successfully underwent the SAVM procedure with a strong safety profile. Patients showed a sustained improvement in PCWP with exercise as well as improvements in functional capacity, symptoms, and overall health status previously seen at 1 month were extended to 6 months. Findings from the feasibility trial will inform the pivotal trial which is expected to begin in late 2023.

Axon Therapies, a private medtech company, is developing a minimally invasive therapy that aims to address a root cause of heart failure by restoring balance to the sympathetic nervous system. Derived from an existing clinical procedure, splanchnic ablation for volume management (SAVM) using the Axon Ablation System enables targeted ablation of the overactive sympathetic nervous system, a key driver of worsening heart failure. The implant-free, catheter-based procedure aims to restore volume balance, stop disease progression and improve patient heart failure symptoms. Axon was founded by proven medtech incubator Coridea, and is backed by leading healthcare investors, including Deerfield Management, Action Potential Venture Capital, and an undisclosed strategic investor. Learn more at axontherapies.com.

SOURCE Axon Therapies, Inc.