Tenaya Therapeutics announces clinical hold on MyPEAK-1 trial lifted by FDA

Tenaya Therapeutics (TNYA) announced it has received official notification from the FDA that the clinical hold on the MyPEAK-1 Phase 1b/2a clinical trial of TN-201 has been removed. All concerns raised by the FDA related to the clinical hold have been addressed. TN-201 is being developed for the potential treatment of Myosin Binding Protein C3-associated hypertrophic cardiomyopathy, a condition caused by insufficient levels of myosin-binding protein C. Tenaya is currently implementing amendments to the study protocol in collaboration with MyPEAK-1 clinical sites after which the company plans to resume dosing. The protocol changes standardize practices adopted in the trial to optimize patient monitoring and management of the immunosuppressive regimen. The immunosuppression regimen of prophylactic prednisone and sirolimus remains unchanged. The protocol amendment formalizes the company’s learnings from the timing and dosing of these agents, which enabled shorter durations and lower cumulative doses of these immunosuppressants between cohorts, despite the higher TN-201 dose. These findings, as well as data from Cohort 1 patients at 52-weeks of follow-up and available data for Cohort 2 patients at 12- and 26-weeks, were recently featured in a late-breaker presentation at the American Heart Association Scientific Sessions with a simultaneous publication in Cardiovascular Research. To date, TN-201 has been generally well tolerated and the MyPEAK-1 data and safety monitoring board endorsed continued enrollment of the trial following a review of all available safety data this summer. There have been no new safety findings of concern since. The company does not expect the hold to impact data milestones or development timelines.