Medera Announces Completion of Cohort A and Initiation of Dosing in Cohort B of MUSIC-HFpEF, a Phase 1/2a Clinical Trial Evaluating First-In-Human Gene Therapy SRD-002 for Heart Failure with Preserved Ejection Fraction
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Heart failure is a global pandemic with an estimated 64.3 million cases worldwide, costing over
US$100B per year - Heart failure with preserved ejection fraction (HFpEF) accounts for nearly half of all heart failure cases, but has limited disease-modifying therapeutics
- Promising efficacy results in cardiovascular performance observed in Cohort A (low-dose SRD-002) at six months with additional data being collected
- Initiated dosing patients in Cohort B (high-dose SRD-002) following recommendation of the DSMB
"New treatment approaches, like Medera's gene therapy product, are critical for patients and caregivers faced with this devastating disease," stated
"The progression of MUSIC-HFpEF, with dosing underway in the second cohort, is a key milestone in the clinical development of our gene therapy candidate SRD-002 as a potential effective treatment for HFpEF patients, who still have significant unmet needs," said
MUSIC-HFpEF is an open-label, dose-escalation, 52-week clinical trial designed to evaluate the safety and tolerability, as well as preliminary efficacy, of SRD-002 in patients diagnosed with HFpEF. SRD-002, a gene therapy candidate utilizing an adeno-associated virus (AAV) vector carrying the cardiac isoform of the sarcoplasmic reticulum calcium ATPase pump (SERCA2a), is administered via Sardocor's proprietary one-time intracoronary infusion methodology. The role of SERCA2a, in relaxation has been demonstrated by
In Cohort A, five patients were infused with SRD-002 at the low dose of 3x10^13 vg per patient. Following the DSMB's recommendation to proceed, investigators are currently enrolling the next five patients in Cohort B, evaluating SRD-002 at the high dose of 4.5x10^13 vg per patient.
For additional information about the MUSIC-HEpEF trial, visit ClinicalTrials.gov using the study identifier NCT06061549.
On
About HFpEF
Heart failure (HF) is a global pandemic with an estimated 64.3 million cases worldwide and a rising prevalence trend. Accounting for 50% or more of the overall HF population, HFpEF is an age-related condition that has become increasingly prevalent in recent years. This surge is partly due to better awareness and identification of the condition and partly due to lifestyle changes affecting cardiac myocytes. Individuals affected by HFpEF experience similar morbidity and mortality to patients with HF with reduced ejection fraction (HFrEF). Despite the growing epidemic of this emerging syndrome, HFpEF-focused interventional trials have had little success, except for the use of sacubitril-valsartan (Entresto™) and the sodium glucose transporter-2 (SGLT-2) inhibitor empagliflozin (Jardiance™) for reducing cardiovascular mortality and heart failure hospitalization. However, these agents are not disease-modifying, highlighting the critical need for therapeutic interventions targeting the physiological mechanisms involved in HFpEF.
About Medera
Medera (www.medera.bio) is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat or currently incurable diseases with significant unmet needs, utilizing next-generation gene and cell-based approaches in combination with bioengineered human-based technology (including the mini-Heart platform). Medera operates via the two preclinical and clinical business units,
Sardocor is dedicated to the clinical development of novel next-generation therapies for Medera. Leveraging
About
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