Medera receives DSMB clearance to initiate Phase 2 portion of MUSIC-HFrEF trial

Medera announced that the independent Data and Safety Monitoring Board has completed its planned review of the MUSIC-HFrEF Phase 1b/2 clinical trial data, recommending the completion of the Phase 1b portion and clearance to initiate the Phase 2 portion of the trial evaluating the gene therapy candidate SRD-001 in patients with heart failure with reduced ejection fraction. HFrEF is a prevalent form of heart disease that accounts for half of an estimated 64.3 million heart failure cases worldwide and is currently considered a mass market incurable disease. The DSMB recommendation is based on the review of data from all nine patients in the Phase 1 portion of the MUSIC-HFrEF trial, an open-label study investigating SRD-001. The Phase 1b portion included six patients in Cohort A and three patients dosed in Cohort B. Topline data from the completed Phase 1 portion of the MUSIC-HFrEF trial with 12-month follow-up will be reported in due course. The Phase 2 portion of the ongoing trial will be a placebo-controlled study with a 1:1 randomization to further evaluate the efficacy and safety of SRD-001 in a larger patient population. The trial is expected to commence patient enrollment in the second quarter of 2025. On September 5, 2024, Medera and Keen Vision Acquisition (KVAC) Corporation announced they had entered into a definitive merger agreement.