Medera Doses First Patient In Phase 2 Of MUSIC-HFrEF Trial Evaluating SRD-001 Gene Therapy For Heart Failure With Reduced Ejection Fraction

Medera Inc., a clinical-stage biopharmaceutical company focused on developing next-generation therapeutics for cardiovascular diseases, announced that the first patient has been dosed in the Phase 2 portion of the MUSIC-HFrEF Phase 1b/2 clinical trial. The trial is evaluating the company’s gene therapy candidate, SRD-001, in patients with heart failure with reduced ejection fraction (HFrEF). The first patient was successfully treated on September 5, 2025, and additional patients are scheduled to receive treatment in the coming weeks.

Heart failure with reduced ejection fraction (HFrEF) is a major form of heart disease that affects nearly half of the estimated 64.3 million individuals living with heart failure worldwide. Despite significant advances in cardiovascular medicine, HFrEF remains a serious and currently incurable condition, representing a major unmet medical need. The Phase 2 portion of the MUSIC-HFrEF study is designed as a randomized, double-blind, placebo-controlled trial. It will include 50 patients, with a 1:1 randomization ratio between the placebo group and those receiving a single 4.5x10¹³ vector genomes (vg) injected dose of SRD-001. 

This phase aims to further assess the efficacy and safety of SRD-001 in a broader patient population, following encouraging findings from the earlier Phase 1b segment. The decision to progress to Phase 2 was supported by the recommendation of an independent Data and Safety Monitoring Board (DSMB) in March 2025, which reviewed data from all nine patients enrolled in the Phase 1b portion and confirmed a favorable safety profile. The patient in the Phase 2 portion was treated using Medera’s proprietary minimally invasive intracoronary infusion technique and tolerated the procedure well, marking a successful start to this next stage of the trial.

“The initiation of the placebo-controlled Phase 2 portion represents a key advancement in evaluating SRD-001’s potential to improve outcomes in patients with advanced heart failure,” said Brian Jaski, M.D., Principal Investigator of MUSIC-HFrEF and Scientific Director of Research at the San Diego Cardiac Center. “We are encouraged by the progress of this gene therapy program, which offers hope to patients living with HFrEF.”

Ronald Li, Ph.D., Chief Executive Officer and Co-Founder of Medera, added, “We are excited to reach this important milestone in our MUSIC-HFrEF program. Advancing SRD-001 into the next phase of clinical testing is a significant step toward our mission of developing transformative, next-generation therapies for patients with heart failure with reduced ejection fraction.”