FDA Places Clinical Hold On Tenaya Therapeutics' TN-201 Trial, Requests Protocol Amendment For Patient Monitoring And Immunosuppression Management
Benzinga Newsdesk 12 months ago
BiotechNewsGeneral
The U.S. Food and Drug Administration ("FDA") has placed a clinical hold on MyPEAKTM-1,Tenaya Therapeutics, Inc.'s ("Tenaya") Phase 1b/2a clinical trial evaluating TN-201 in MYBPC3-associated hypertrophic cardiomyopathy,
The U.S. Food and Drug Administration ("FDA") has placed a clinical hold on MyPEAKTM-1,Tenaya Therapeutics, Inc.'s ("Tenaya") Phase 1b/2a clinical trial evaluating TN-201 in MYBPC3-associated hypertrophic cardiomyopathy, requesting an amendment to the protocol primarily to standardize activities related to patient monitoring and management of the immunosuppression regimen across trial sites.
The request for a protocol amendment followed proactive correspondence with the FDA related to future plans for the TN-201 program and is based primarily on data previously reviewed by the trial's independent Data Safety Monitoring Board ("DSMB") during summer 2025, which concluded that TN-201 had an acceptable safety profile to allow enrollment of expansion cohorts at either the 3E13 vg/kg (Cohort 1) or 6E13 vg/kg (Cohort 2) dose levels. To date, TN-201 has been generally well tolerated and since the DSMB review, there have been no new meaningful safety events associated with TN-201.
Tenaya is working swiftly and collaboratively with the FDA to resolve the clinical hold and intends to resume dosing once the protocol changes have been implemented at trial sites. Tenaya does not expect this action to impact data milestones or development timelines for TN-201.