CADENCE and Medera launch Asia’s first multi centre gene therapy trial for heart failure

• Cardiovascular Disease National Collaborative Enterprise (CADENCE) and Medera announce the initiation of Asia’s first multi-centre gene therapy clinical trial for heart failure, with Singapore being the first and only site selected outside of the United States (US).

• In Singapore, about 2.5% of Singaporeans aged 60 years old or above have heart failure. The condition is often the result of ischaemic heart disease, which contributes to around 20% of deaths here. Southeast Asian patients tend to present with heart failure at a younger age (mean age of 54 years) than those in the Western population (mean age of 75 years).

• Developed by Medera Inc. (“Merdera”)’s solely owned subsidiary Sardocor, the gene therapy product SRD-001, an adeno-associated virus (AAV)-based gene therapy, can potentially improve the pumping action of the heart muscle. This therapy is intended to treat patients with heart failure with reduced ejection fraction (HFrEF). SRD-001 has received an Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA).

• This trial marks the first collaboration between Singapore's two national heart centres National Heart Centre Singapore (NHCS), National University Heart Centre Singapore (NUHCS) and with Tan Tock Seng Hospital (TTSH).

SINGAPORE – 19 November 2024 – The Cardiovascular Disease National Collaborative Enterprise (CADENCE) and Medera Inc. (“Merdera”)’s Sardocor are pleased to announce the initiation of a ground-breaking clinical trial for a novel gene therapy product aimed at treating heart failure. This marks the first multi-centre gene therapy trial in Asia for heart failure, with Singapore being the first and only site selected outside of the United States (US) for this significant translational breakthrough. Heart failure is a global challenge, with Singapore facing a particularly high burden. About 2.5% of Singaporeans aged 60 years old or above have heart failure. The condition is often the result of ischaemic heart disease, which contributes to around 20% of deaths in Singapore ↗ (opens in new tab). Southeast Asian patients tend to present with heart failure at a younger age (mean age of 54 years) than those in the Western population (mean age of 75 years) ↗ (opens in new tab). Furthermore, they tend to present with more severe conditions which require intensive care, longer length of hospital stay, and a higher hospital mortality rate ↗ (opens in new tab).

Developed by Medera’s solely owned subsidiary Sardocor, the gene therapy product SRD-001 can potentially improve the pumping action of the heart muscle, reduce symptoms and signs of heart failure, and reduce the risk of hospital re-admissions. SRD-001 is intended to treat patients with heart failure with reduced ejection fraction (HFrEF).

Having received an Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA), SRD-001 (NCT04703842) ↗ (opens in new tab), phase 1/2a is expected to complete its enrolment, followed by an interim data readout ↗ (opens in new tab) and the randomised Phase 2b in 2025.

Medera’s Sardocor has also obtained IND clearances as well as Fast Track Designation (SRD-002; NCT06061549) from the US Food and Drug Administration (FDA) ↗ (opens in new tab)for HFpEF and Orphan Drug Designation (SRD-003; NCT0622466) for their gene therapy trial in patients with Duchenne cardiomyopathy ↗ (opens in new tab), highlighting its potential as a new first-in-human treatment option for patients afflicted with different types of HF. SRD-001/2/3 employs an adeno-associated virus-based gene therapy, delivered directly to cardiac ventricular muscle cells via Sardocor’s proprietary intracoronary infusion system.

Furthermore, clinical dosages have been optimised by the Human mini-Heart® technology developed by Novoheart, another solely owned subsidiary of Medera, in accordance with the FDA Modernisation Act 2.0. On 21 November 2023, the National Heart Centre Singapore (NHCS) announced a partnership with Novoheart to develop Asia’s first bioengineered human heart-in-a-jar with heart failure for precision medicine ↗ (opens in new tab).

This trial marks the first collaboration between Singapore's two national heart centres (NHCS and NUHCS), and with TTSH. This is a testament to the country’s robust cardiovascular research infrastructure. It also highlights CADENCE’s efforts in streamlining clinical trial processes across these institutions. This includes streamlining contracting procedures, simplifying the costs of conducting cardiovascular clinical trials across these sites, as well as providing a centralised point of-contact for companies looking to conduct clinical trials and bring novel therapies to Singapore.

Professor Roger Hajjar, MD, President and co-founder of Medera, expressed enthusiasm about the trial's launch: "Medera and Sardocor are very excited to initiate this trial in Singapore, the first site outside of the US, by deploying this cutting-edge technology for the first time ever to Asian heart failure patients. Sardocor’s unique regulated intracoronary delivery methodology is a minimally invasive procedure that targets the heart directly, designed to minimise drug dosage and therefore side-effects while preserving efficacy. While the Singapore trial’s initial focus is on congestive heart failure, this foundation will enable subsequent expansion to other cardiac indications."

Adding to the significance of this trial, Professor Derek Hausenloy, Executive Director of CADENCE, and Director of the National Heart Research Institute Singapore at NHCS, remarked:

"The launch of the SRD-001 trial in Singapore is a landmark moment for cardiovascular cell and gene therapy research in Asia. It underscores our commitment to integrate cutting-edge research and technologies to combat cardiovascular diseases. By bringing together the best of our national research capabilities and expertise, we aim to pave the way for innovative treatments that can significantly improve patient outcomes. This trial not only highlights Singapore’s position as a leader in cardiovascular research but also showcases our potential to contribute to the global fight against heart failure."

“Medera is extremely delighted to partner with Singapore’s cardiac experts from the public healthcare institutions in its first efforts in Asia to comprehensively cover important areas from mini-Heart® based drug discovery all the way to clinical gene therapy starting with SRD-001 for the benefit of the large number of Asian heart patients,” said Professor Ronald Li, PhD, CEO and co-founder of Medera.

About CADENCE

Established in February 2023, the Cardiovascular Disease National Collaborative Enterprise (CADENCE) is a national clinical translational programme aimed at synergising cardiovascular research and technology capabilities across Singapore.

Its goal is to integrate existing research capabilities, and bring together the strongest basic, clinical, and translational talent and expertise across Singapore and institutions, to establish a focused and impactful national cardiovascular disease research and translational programme with world-class peaks of excellence.

To achieve this, CADENCE has established four national joint platforms focused on data science, clinical trials, and artificial intelligence/digital health, together with a business intelligence and development unit to attract industry collaborations/external investments.

CADENCE is a programme of the Consortium for Clinical Research and Innovation, Singapore ↗ (opens in new tab) (CRIS). CADENCE is supported by the Singapore Ministry of Health through the National Medical Research Council (NMRC) Office, MOH Holdings Pte Ltd under the NMRC RIE2025 National Clinical Translational Programme Funding Initiative (MOH-001277).

For more information, please visit https://cadence-cvd.sg ↗ (opens in new tab)

About Medera

Medera (www.medera.bio ↗ (opens in new tab)) 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. 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 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-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.

For media enquiries, please contact:

Charlene Tan
Manager, Corporate Communications
Consortium for Clinical Research and Innovation, Singapore
charlene.tan@cris.sg

Medera and Sardocor

Stephanie Carrington (Investor Relations)
ICR Healthcare
Stephanie.Carrington@icrhealthcare.com

Sean Leous (Media Relations)
ICR Healthcare
Sean.Leous@icrhealthcare.com