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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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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: 11 Sep 2024

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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

    • 05 Sep 2024 According to a MedERA media release, the company has been granted Investigational New Drug (IND) clearances from the US FDA for this trial. To date, six patients have been infused with SRD-001 in Cohort A (low-dose 3x1013 vg per patient) and one patient has been infused in Cohort B (high-dose 4.5x1013 vg per patient). The company expects to complete the Phase 1/2a portion of the trial in the fourth quarter and commence an international randomized Phase 2b portion shortly after.
    • 01 May 2024 According to a MedERA media release, a clinical update of this trial was featured in a late-breaking oral presentation at the American Society of Gene & Cell Therapy (ASGCT) in May 2024.
    • 18 Jan 2024 Planned primary completion date changed from 1 Dec 2023 to 31 Dec 2025.

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