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A Phase 1/2 Trial of the Safety and Efficacy of SRD-001 (AAV1/SERCA2a) in Subjects With Heart Failure With Reduced Ejection Fraction

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Trial Profile

A Phase 1/2 Trial of the Safety and Efficacy of SRD-001 (AAV1/SERCA2a) in Subjects With Heart Failure With Reduced Ejection Fraction

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 20 Jun 2025

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At a glance

  • Drugs SERCA 2a gene therapy (Primary)
  • Indications Cardiomyopathies; Heart failure
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms MUSIC-HFrEF1
  • Sponsors Sardocor

Most Recent Events

  • 13 Jun 2025 According to a Medera media release, data from this trial was presented at the 2025 International Society for Stem Cell Research (ISSCR) Annual Meeting, held June 11 to 14 in Hong Kong.
  • 20 Mar 2025 According to a Medera media release, phase 2 trial is expected to commence patient enrollment in the second quarter of 2025; Topline data from the completed Phase 1 portion of the MUSIC-HFrEF trial with 12-month follow-up will be reported in due course.
  • 20 Mar 2025 According to a Medera media release, the independent Data and Safety Monitoring Board (DSMB) 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 HFrEF; The DSMB recommendation is based on the review of data from all nine patients in the Phase 1 portion of this trial

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