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

• 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

SUMMIT, N.J. and BOSTON, Oct. 24, 2024 /PRNewswire/ -- Medera Inc. today announced that its clinical-stage gene therapy subsidiary, Sardocor Corp., has successfully completed its Cohort A (low-dose). Following the recommendation of the Data Safety Monitoring Board (DSMB), dosing has begun for patients in Cohort B (high-dose). This Phase 1/2a clinical trial evaluates the first-in-human cardiac gene therapy candidate SRD-002 for the treatment of Heart Failure with Preserved Ejection Fraction (HFpEF).

"New treatment approaches, like Medera's gene therapy product, are critical for patients and caregivers faced with this devastating disease," stated Marat Fudim, MD, MHS, Advanced Heart Failure Specialist and Associate Professor at Duke University Medical Centre and site principal investigator. "We look forward to continuing this critical research in the second cohort."

"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 Roger Hajjar, MD, President and co-founder of Medera. "SRD-002 has been well tolerated with no unexpected events or toxicities observed and promising efficacy results observed in some patients in Cohort A at the six-month mark, with additional data being collected and analysed. We expect to complete enrolment in the second cohort in the first quarter 2025, with an interim data readout anticipated in the first half of 2025."

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 Novoheart (a subsidiary of Medera which develops cardiac tissue engineering technology for disease modelling and drug discovery) in their first-of-a-kind bioengineered human mini-Heart HFpEF models, co-developed with AstraZeneca as previously announced. Delivery of SRD-002 in the human mini-Heart HFpEF models leads to improved relaxation defects as published.  Human mini-Heart models have also been used to optimise dosages. These data were used to support our Fast Track Designation (FTD) for MUSIC-HFpEF obtained from the FDA, in accordance to the Modernization Act 2.0.

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 September 5, 2024, Medera and Keen Vision Acquisition Corporation ("KVAC") (Nasdaq: KVAC, KVACW) announced they had entered into a definitive merger agreement.  

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, 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.

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-induced 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.

About Keen Vision Acquisition Corporation

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. EF Hutton LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, are serving as Capital Markets Advisors for KVAC.

www.kv-ac.com

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SOURCE Keen Vision Acquisition Corporation; Medera Inc.