Medera Showcases Interim Data From First-in-Human Gene Therapy Trial For HFpEF In Late-Breaking Presentation At Heart Failure 2025 Congress; Clinical Trial Show Favorable Safety Profile And Early Clinical Benefits With SRD-002 Gene Therapy

• Results from MUSIC-HFpEF Phase 1/2a clinical trial show favorable safety profile and early clinical benefits with SRD-002 gene therapy

BOSTON, May 19, 2025 (GLOBE NEWSWIRE) -- Medera Inc. ("Medera"), a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing a range of next-generation therapeutics, today announced that positive interim data from its ongoing MUSIC-HFpEF Phase 1/2a clinical trial was presented at the Heart Failure 2025 Congress taking place in Belgrade, Serbia. The late-breaking presentation, titled "Gene therapy for heart failure with preserved ejection fraction," was delivered by Marat Fudim, MD, MHS, Advanced Heart Failure Specialist and Associate Professor at Duke University Medical Center, during the "Late-Breaking Clinical Trials in Chronic Heart Failure" session.

The MUSIC-HFpEF trial is investigating SRD-002, a one-time gene therapy treatment for heart failure with preserved ejection fraction (HFpEF) delivered through a proprietary minimally invasive intracoronary infusion methodology. SRD-002 utilizes an adeno-associated type 1 virus vector carrying the cardiac isoform of the sarcoplasmic reticulum calcium ATPase pump (SERCA2a) to directly target the molecular pathways underlying the core pathology of HFpEF by enhancing myocardial relaxation and reducing stiffness. The trial is evaluating the therapy in HFpEF patients with exercise-induced diastolic dysfunction, including those with LVEF ≥ 50% and symptomatic HFpEF defined by prior hospitalization or New York Heart Association (NYHA) Class II or III symptoms.

The presentation highlighted interim data from the ongoing trial, which, as of the data cutoff date, has treated five patients in Cohort A with a low dose of 3x1013 viral genomes (vg) per patient and one patient in Cohort B at a dose of 4.5x1013 vg per patient. With follow-up ranging from 4 to 16 months, no gene therapy-related serious adverse events have been reported. Four out of five patients in the low-dose group have shown improvements in NYHA heart failure classification at 6 months, with clinically meaningful improvements in 6-minute walk test (6MWT), decreases/stabilization in NT-Pro-BNP, and high-sensitivity troponin observed in some patients. The enrollment of patients at the higher dose of 4.5x1013 vg per patient is ongoing.