Medera’s SRD-001 Gene Therapy for Heart Failure with Reduced Ejection Fraction: DSMB Recommends Advancement to Phase 2
Boston, MA, March 20, 2025 – Medera Inc., a pioneering clinical-stage biopharmaceutical company specializing in the development of next-generation therapeutics for cardiovascular diseases with significant unmet needs, announced today that the Independent Data and Safety Monitoring Board (DSMB) has completed its planned review of the MUSIC-HFrEF Phase 1b/2 clinical trial data. Following a thorough assessment, the DSMB recommended the completion of the Phase 1b portion and clearance to initiate the Phase 2 portion of the trial.
About MUSIC-HFrEF and SRD-001
The MUSIC-HFrEF trial is designed to evaluate the safety, tolerability, and efficacy of Medera’s gene therapy candidate, SRD-001, in patients with heart failure with reduced ejection fraction (HFrEF). HFrEF is a debilitating and life-threatening condition characterized by a decreased ability of the heart to pump blood effectively. This condition affects millions of people worldwide, and current treatments offer limited benefits, making the development of novel therapies a critical priority.
Phase 1b Results and DSMB Recommendation
The DSMB’s review of the Phase 1b data showed that SRD-001 was well-tolerated, with no unexpected safety concerns. The results also suggested potential clinical benefit in patients with HFrEF. Based on these findings, the DSMB recommended that the trial proceed to the Phase 2 portion, which will involve a larger patient population and a more extensive evaluation of the therapy’s efficacy.
Implications for Patients and the World
For patients with HFrEF, this development could represent a significant step forward in the treatment of their condition. SRD-001 has the potential to provide a more effective and targeted therapy than current treatments, which can improve patients’ quality of life and reduce the risk of hospitalization and complications. Moreover, the success of SRD-001 could pave the way for further advancements in gene therapy for cardiovascular diseases and other conditions.
Global Impact
Heart failure affects millions of people worldwide, and the current treatment landscape offers limited benefits. The successful advancement of SRD-001 from Phase 1b to Phase 2 represents a crucial milestone in the development of a more effective therapy for HFrEF. This achievement could significantly impact the lives of countless individuals, reducing the burden of heart failure on healthcare systems and improving overall patient outcomes.
Conclusion
Medera’s announcement of the DSMB’s recommendation to advance SRD-001 from Phase 1b to Phase 2 in the MUSIC-HFrEF trial marks an essential step forward in the development of a novel and potentially more effective therapy for heart failure with reduced ejection fraction. The positive results from the Phase 1b portion of the trial offer hope for patients with this debilitating condition and the potential for significant improvements in the treatment landscape for cardiovascular diseases. As the trial progresses, the world eagerly awaits the continued success of SRD-001 and the potential it holds for transforming the lives of millions of people affected by heart failure.
- Medera Inc. announces DSMB recommendation to advance SRD-001 to Phase 2 in MUSIC-HFrEF trial.
- SRD-001 is a gene therapy candidate for heart failure with reduced ejection fraction (HFrEF).
- Phase 1b results showed SRD-001 was well-tolerated and suggested potential clinical benefit.
- Success of SRD-001 could pave the way for further advancements in gene therapy for cardiovascular diseases.
- Heart failure affects millions worldwide, and current treatments offer limited benefits.
- Advancement of SRD-001 from Phase 1b to Phase 2 represents a crucial milestone in the development of a more effective therapy for HFrEF.
