BOSTON, April 01, 2025 (GLOBE NEWSWIRE) -- Medera Inc. (“Medera”), a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing a range of next-generation therapeutics, today announced that updated results from its ongoing MUSIC-HFpEF Phase 1/2a clinical trial investigating SRD-002, a one-time gene therapy treatment delivered through a proprietary minimally invasive intracoronary infusion methodology, were presented at the 2025 HFpEF Summit held March 19-21, 2025, in Beverly Hills, CA.
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. SRD-002 is a gene therapy utilizing an adeno-associated type 1 virus vector carrying the cardiac isoform of the sarcoplasmic reticulum calcium ATPase pump (SERCA2a) that directly targets the molecular pathways underlying the core pathology of HFpEF by enhancing myocardial relaxation and reducing stiffness.
The presentation titled, “Targeting Diastolic Dysfunction in HFpEF- SERCA2a Gene Therapy,” was delivered by Marat Fudim, MD, MHS, Advanced Heart Failure Specialist and Associate Professor at Duke University Medical Center and site principal investigator, on Friday, March 21st. The presentation highlighted data from the trial, which, as of the data cutoff date of February 25, 2025, has treated five patients in Cohort A with a low dose of 3×10¹³ viral genomes (vg) per patient and one patient has been dosed in Cohort B at a dose of 4.5×10¹³ vg per patient. With follow-up ranging from 2 to 15 months, no gene therapy-related serious adverse events have been reported. Four out of the five patients in the low-dose group have shown improvements in New York Heart Association (NYHA) heart failure classification at 6 months, with clinically meaningful improvements in 6-minute walk test (6MWT), decreases/stabilization in NT-Pro-BNP, and high-sensitivity troponin observed in some patients. The enrollment of patients at the higher dose of 4.5x1013 vg per patient is ongoing.
"New treatment approaches, like Medera's gene therapy product, targeting critical pathways in the heart, are crucial for patients and caregivers faced with this difficult-to-treat disease," stated Marat Fudim, MD, MHS, Advanced Heart Failure Specialist and Associate Professor at Duke University Medical Center and site principal investigator. "The encouraging early results presented at this summit reflect important progress in this critical research."
"We are excited to share our encouraging results from the MUSIC-HFpEF trial at this prestigious summit," said Ronald Li, Ph.D., CEO and co-founder of Medera. "This groundbreaking trial represents the first-in-human gene therapy approach for patients with HFpEF and features unique hemodynamic characterization of patients within the study using precise measurements of pulmonary capillary wedge pressure (PCWP) at rest and during exercise. Our clinical findings suggest this approach may offer an alternative treatment strategy to HFpEF patients, where a significant unmet need remains."
The HFpEF Summit is a biannual, two-day meeting bringing together internationally recognized leaders in the clinical, biological, and translational study of HFpEF. This summit focused on the latest insights and innovations for scientists, clinicians, researchers, and other healthcare professionals interested in all aspects of HFpEF.
For additional information about the MUSIC-HFpEF trial, visit ClinicalTrials.gov using the study identifier NCT06061549.
On September 5, 2024, Medera and Keen Vision Acquisition Corporation ("KVAC") (NASDAQ:KVAC, KVACW), announced they had entered into a definitive merger agreement.
About Heart Failure with Preserved Ejection Fraction (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 is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat and currently incurable diseases by developing a range of next-generation therapeutics. Medera operates via its two preclinical and clinical business units, Novoheart and Sardocor, respectively.
Novoheart capitalizes on the world’s first and award-winning “mini-Heart” Technology for revolutionary disease modelling and drug discovery, uniquely enabling the modelling of human-specific diseases and discovery of therapeutic candidates free from species-specific differences in accordance to the FDA Modernization Act 2.0. Novoheart's versatile technology platform provides a range of state-of-the-art automation hardware and software as well as screening services, for human-specific disease modelling, therapeutic target discovery and validation, drug toxicity and efficacy screening, and dosage optimization carried out in the context of healthy and/or diseased human heart chambers and tissues. Global pharmaceutical and academic leaders are using Novoheart's technology platform for their drug discovery and development purposes. The Novoheart platform has facilitated and accelerated the development of Sardocor's lead therapeutic candidates that are currently in clinical trials.
Sardocor is dedicated to the clinical development of novel next-generation therapies for Medera. Leveraging Novoheart’s human-based drug discovery and validation platforms, Sardocor aims to expedite drug development and regulatory timelines for its gene and cell therapy pipeline. Sardocor has received Investigational New Drug (IND) clearances from the FDA for three ongoing AAV-based cardiac gene therapy clinical trials targeting Heart Failure with Reduced Ejection Fraction (HFrEF), Heart Failure with Preserved Ejection Fraction (HFpEF) with the Fast Track Designation, and Duchenne Muscular Dystrophy-associated Cardiomyopathy (DMD-CM) with the Orphan Drug Designation. Additionally, Sardocor's pipeline includes four preclinical gene therapy and three preclinical small molecule candidates targeting various cardiac, pulmonary, and vascular diseases.
Keen Vision Acquisition Corp ("KVAC"), listed on Nasdaq, is a blank check company incorporated for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. KVAC is focused on biotechnology, consumer goods or agriculture opportunities, which are also evaluated on their sustainability, environmental, social, and corporate governance ("ESG") imperatives.
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