CADENCE and Medera's Sardocor have initiated a groundbreaking clinical trial for a novel gene therapy product aimed at treating heart failure in Singapore. This marks Asia's first multi-centre gene therapy trial for heart failure, with Singapore being the first and only site selected outside of the United States for this significant translational breakthrough.
The Cardiovascular Disease National Collaborative Enterprise (CADENCE) has partnered with Medera Inc.'s subsidiary Sardocor to bring this innovative treatment approach to Asian patients. The trial focuses on SRD-001, a gene therapy product designed to address heart failure with reduced ejection fraction (HFrEF), which accounts for approximately half of all heart failure cases worldwide.
Heart Failure Burden in Singapore and Southeast Asia
Heart failure represents a significant health challenge in Singapore, affecting about 2.5% of Singaporeans aged 60 years or older. The condition, often resulting from ischemic heart disease, contributes to approximately 20% of deaths in Singapore.
Southeast Asian patients present unique clinical characteristics compared to Western populations:
- They develop heart failure at a significantly younger age (mean age of 54 years versus 75 years in Western populations)
- They typically present with more severe conditions requiring intensive care
- They experience longer hospital stays and higher hospital mortality rates
These regional differences underscore the importance of developing targeted therapies that address the specific needs of Asian heart failure patients.
SRD-001: A Novel Gene Therapy Approach
SRD-001, developed by Sardocor, offers a promising new approach to treating heart failure. The therapy aims to:
- Improve the pumping action of the heart muscle
- Reduce symptoms and signs of heart failure
- Decrease the risk of hospital readmissions
The treatment employs an adeno-associated virus-based gene therapy, delivered directly to cardiac ventricular muscle cells via Sardocor's proprietary intracoronary infusion system. This minimally invasive procedure targets the heart directly, designed to minimize drug dosage and side effects while preserving efficacy.
Having received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA), the Phase 1/2a trial (NCT0470384) is expected to complete enrollment, followed by an interim data readout and the randomized Phase 2b in 2025.
Expanding Therapeutic Pipeline
Beyond SRD-001, Medera's Sardocor has secured additional regulatory designations for its gene therapy pipeline:
- Fast Track Designation for SRD-002 (NCT06061549) for heart failure with preserved ejection fraction (HFpEF)
- Orphan Drug Designation for SRD-003 (NCT0622466) for patients with Duchenne cardiomyopathy
These designations highlight the potential of Sardocor's gene therapy platform as a first-in-human treatment option for various types of heart failure.
Innovative Research Technologies
A notable aspect of this clinical program is the optimization of clinical dosages using Human mini-Heart® technology developed by Novoheart, another wholly owned subsidiary of Medera. This approach aligns with the FDA Modernization Act 2.0, which encourages alternative testing methods.
In 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, further strengthening the collaborative research infrastructure.
Collaborative Research Infrastructure
This trial represents the first collaboration between Singapore's two national heart centers (NHCS and NUHCS), along with Tan Tock Seng Hospital (TTSH). The partnership demonstrates Singapore's robust cardiovascular research capabilities and CADENCE's efforts to streamline clinical trial processes across these institutions.
CADENCE has worked to simplify contracting procedures, reduce costs of conducting cardiovascular clinical trials, and provide a centralized point of contact for companies looking to conduct clinical trials in Singapore.
Professor Roger Hajjar, MD, President and co-founder of Medera, expressed enthusiasm about the trial: "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. While the Singapore trial's initial focus is on congestive heart failure, this foundation will enable subsequent expansion to other cardiac indications."
Professor Derek Hausenloy, Executive Director of CADENCE and Director of the National Heart Research Institute Singapore at NHCS, added: "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. 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."
Professor Ronald Li, PhD, CEO and co-founder of Medera, emphasized the comprehensive approach: "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."
The collaboration was formalized with a Memorandum of Understanding (MoU) between CADENCE and Medera, marking a significant step forward in bringing innovative gene therapy approaches to heart failure patients in Asia.
