Overview of Heart Disease
Heart disease comes in many forms, affects individuals of all ages, and is a result of many factors, such as genetics and environment. It is also the leading cause of death in the world, accounting for more deaths than from all cancers combined.
Some sobering statistics help illustrate the burden that heart diseases impose on human health:
In the U.S., more than 30 million adults are diagnosed with heart disease.
In the U.S. approximately 35,000 children are born each year with congenital heart disease.
There are over 250 known genetically defined heart disease disorders, where the primary source of morbidity and mortality involves the heart.
Unfortunately, the rate of cardiovascular drug product approvals has declined in recent years. What’s more? Current therapies available for heart disease come with limitations – few approved products address the underlying cause of disease.
We aim to deliver therapies that address the underlying causes of heart disease, to improve the lives and realities of those affected by it every day.
Learn more about Tenaya’s potential treatment approach in this video that outlines heart conditions that affect children and adults and also provides detail into how our science is working to change future treatment outlook for patients:
TN-301 Phase 1 Clinical Trial:
We are currently enrolling healthy participants in our Phase 1 clinical study evaluating safety and tolerability of small molecule TN-301 that aims to address heart failure with preserved ejection fraction.
TN-201 Phase 1b Clinical Trial and Non-Interventional Studies:
We are initiating a Phase 1b clinical trial in the U.S. to evaluate the safety, tolerability and clinical efficacy of TN-201. The multi-center trial will enroll adults diagnosed with non-obstructive HCM due to a MYBPC3 mutation who are symptomatic.
We are also conducting two non-interventional studies to better understand and characterize MYBPC3-associated HCM. The first study, MyClimb, is a global natural history study for pediatric patients. A second study is enrolling adults with MYBPC3-associated HCM to assess the presence of neutralizing antibodies to AAV.
TN-401 Global Non-Interventional Study and Clinical Plans:
We have initiated a global non-interventional study to collect treatment history and seroprevalence to AAV9 antibodies data among ARVC patients with the PKP2 genetic mutation. Later this year, we plan to submit an IND application to the U.S. FDA, which would allow us to conduct a clinical study of our TN-401 gene therapy.
Heart disease has many faces and touches many lives. We aim to share stories, and to add more over time, that not only detail the impact of heart disease on daily life but also shed light on the many different ways in which patients are working to drive awareness of heart disease and educate their own communities.
To learn more about the various forms of heart disease including genetic and inherited diseases please visit: