Medera Receives DSMB Clearance to Initiate Phase 2 Portion of MUSIC-HFrEF Phase 1b/2 Trial for SRD-001 Gene Therapy in Heart Failure with Reduced Ejection Fraction
BOSTON, March 20, 2025 (GLOBE NEWSWIRE) -- Medera Inc. (“Medera”), a clinical-stage biopharmaceutical company focused on cardiovascular diseases with high unmet need by developing a range of next-generation therapeutics, today announced that 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 heart failure with reduced ejection fraction (HFrEF).
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 (low-dose 3x1013 vg per patient) and three patients dosed in Cohort B (high-dose 4.5x1013 vg per patient). 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 (placebo versus 4.5x1013 vg injected dose per patient) 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.
"The DSMB clearance to advance to Phase 2 represents a significant milestone for patients with advanced heart failure who have limited treatment options," said Brian Jaski, M.D., the Principal Investigator of MUSIC-HFrEF and Director of Cardiology at San Diego Cardiac Center.
"We are pleased with the DSMB's recommendation, which validates our approach and allows us to expand our clinical program," said Ronald Li, Ph.D., CEO and co-founder of Medera. "This clearance brings us one step closer to our goal of developing transformative therapies for HFrEF patients."
On September 5, 2024, Medera and Keen Vision Acquisition Corporation (“KVAC”) (NASDAQ:KVAC, KVACW), announced they had entered into a definitive merger agreement (the “Merger Agreement”).
About SRD-001
SRD-001 is an investigational gene therapy candidate that contains an adeno-associated virus serotype 1 (AAV1) vector expressing the transgene for sarco(endo)plasmic reticulum Ca2+ ATPase 2a isoform (SERCA2a), in anti-AAV1 neutralizing antibody (NAb) negative subjects with ischemic or non-ischemic cardiomyopathy and New York Heart Association (NYHA) class III/IV symptoms of heart failure with reduced ejection fraction (HFrEF).
About Heart Failure with reduced Ejection Fraction (HFrEF)
HErEF is a complex cardiovascular pathophysiological syndrome that impairs normal cardiac function and results in the inability of the heart to pump a sufficient supply of blood to meet the body demand. Once established, HFrEF is generally progressive, irreversible, associated with debilitating symptoms, frequent re-hospitalizations and high mortality rates. An urgent need exists for disease modifying therapies, such as SRD-001, which aim to reverse the pathophysiology of HFrEF.
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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