We are excited to announce the launch of our groundbreaking clinical trial investigating the potential of YAP101 (AAV9-Sav-shRNA) gene therapy for heart regeneration following myocardial infarction (MI)! This innovative approach aims to stimulate cardiomyocyte renewal, offering hope for improved cardiac function in patients who have suffered an MI. https://clinicaltrials.gov/study/NCT06831825?limit=100&intr=YAP101%20%5C(AAV9-Sav-shRNA%5C)&rank=1

Background

Heart failure resulting from MI remains a leading cause of morbidity and mortality worldwide. Traditional treatments primarily focus on managing symptoms and preventing further damage, but they do not address the loss of cardiomyocytes. Our preclinical studies demonstrated that targeting the Hippo signaling pathway, specifically the Salvador (Sav) gene, can induce cardiomyocyte proliferation and improve heart function. In a pig model of ischemia/reperfusion-induced MI, local knockdown of the Sav gene using an adeno-associated virus 9 (AAV9) vector led to a 14.3% improvement in ejection fraction and reduced scar size three months post-treatment. pmc.ncbi.nlm.nih.gov

The YAP101 Clinical Trial

Building upon these promising results, our clinical trial aims to evaluate the safety and efficacy of YAP101 in human subjects. YAP101 utilizes an AAV9 vector to deliver short hairpin RNA (shRNA) targeting the Sav gene directly to the heart tissue, promoting cardiomyocyte renewal and potentially restoring cardiac function. This Phase I/II trial is a multicenter, randomized, double-blind, placebo-controlled study enrolling adult patients who have experienced an MI within the past 30 days and exhibit reduced left ventricular ejection fraction. Participants will receive a single intracoronary infusion of YAP101 or placebo and will be monitored over a 12-month period for safety, cardiac function, and overall clinical outcomes.

Eligibility Criteria

Key inclusion criteria:

• Adults aged 18-75 years

• Documented MI within the past 30 days

• Left ventricular ejection fraction ≤40%

Key exclusion criteria:

• History of malignancy within the past five years

• Chronic infections or immunosuppressive conditions

• Participation in another investigational study within 30 days

How to Participate

If you or someone you know meets the eligibility criteria and is interested in participating, please visit our trial registration page on ClinicalTrials.gov (NCT06831825) for more information and contact details. We believe that YAP101 has the potential to revolutionize the treatment of heart failure post-MI by addressing the root cause—loss of functional cardiomyocytes. Your participation could significantly advance cardiac care and offer hope to millions affected by heart disease.