Tenaya Therapeutics Announces Rapid Resolution and Lifting of Clinical Hold for MyPEAK-1™ Phase 1b/2a Clinical Trial of TN-201 Gene Therapy

Core Viewpoint - Tenaya Therapeutics has received FDA notification that the clinical hold on its MyPEAK-1 Phase 1b/2a trial for TN-201 has been lifted, allowing the company to proceed with the trial aimed at treating MYBPC3-associated hypertrophic cardiomyopathy (HCM) [1][3] Group 1: Clinical Trial Updates - The company is amending the study protocol in collaboration with clinical sites to optimize patient monitoring and management of the immunosuppressive regimen, while the immunosuppression regimen remains unchanged [2] - The MyPEAK-1 trial is a multi-center, open-label, dose-escalating study involving symptomatic adults diagnosed with MYBPC3-associated HCM, assessing the safety and efficacy of TN-201 gene replacement therapy [4] - TN-201 has been generally well tolerated, and the Data Safety Monitoring Board has endorsed continued enrollment following a review of safety data [3] Group 2: Drug and Disease Information - TN-201 is an AAV9-based gene therapy designed to deliver a working MYBPC3 gene to heart muscle cells, aiming to increase MyBP-C protein levels and potentially reverse the disease after a single dose [7] - MYBPC3-associated HCM is the most common genetic cause of HCM, affecting approximately 120,000 patients in the U.S., and there are currently no approved therapies addressing its underlying genetic cause [6] Group 3: Company Overview - Tenaya Therapeutics is a clinical-stage biotechnology company focused on developing potentially curative therapies for heart disease, with a pipeline that includes TN-201 and other gene therapies [8][9]