Medera Inc. announced updated positive results from its Phase 1/2a clinical trial of SRD-002, a gene therapy for heart failure with preserved ejection fraction (HFpEF). The therapy, delivered via a minimally invasive intracoronary infusion, showed promising improvements in patients’ heart failure classification, exercise capacity, and key biomarkers. The data was presented at the 2025 HFpEF Summit.
This news holds substantial potential for addressing the significant unmet need in HFpEF treatment. Current medications for HFpEF primarily manage symptoms rather than targeting the underlying disease mechanisms. SRD-002’s mechanism, enhancing myocardial relaxation and reducing stiffness by delivering the SERCA2a gene, represents a novel and potentially disease-modifying approach. This could translate into improved quality of life and potentially longer survival for patients with this challenging condition. The positive early data also creates momentum for further investment and research in gene therapies for cardiovascular diseases.
The trial has dosed six patients across two cohorts, with doses of 3×10¹³ and 4.5×10¹³ viral genomes per patient, respectively. Notably, no serious adverse events related to the gene therapy have been observed. Four of five patients in the lower dose cohort showed improved heart failure classification at six months, accompanied by better exercise capacity as measured by the 6-minute walk test. Some patients also exhibited improvements in NT-proBNP and high-sensitivity troponin, biomarkers indicative of heart health. Enrollment continues for the higher dose cohort.
These early positive results pave the way for continued clinical development of SRD-002. The ongoing trial will provide further data on safety and efficacy, potentially leading to larger-scale studies and eventual regulatory approval. The innovative intracoronary delivery method and targeted mechanism of action position SRD-002 as a potential game-changer in the HFpEF landscape, offering hope for a disease-modifying treatment where few currently exist.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
