Following a crucial update regarding its clinical trials, shares of Tenaya Therapeutics, Inc. (NASDAQ: TNYA) have experienced a notable increase on the US stock charts. TNYA stock rose 22.86% to conclude the previous session at $2.15, underscoring investor confidence in its ongoing research and development efforts.
Tenaya Shared Clinical Trial Progress
With an emphasis on the gene therapy TN-201, Tenaya Therapeutics (TNYA) gave updates on its Phase 1b/2 MyPEAK-1 clinical study. The goal of this novel therapy is to cure myosin-binding protein C or MyBP-C-associated HCM (hypertrophic cardiomyopathy), a cardiac disorder caused by insufficient myosin-binding protein C levels.
Profile of Safety and Tolerability
Determining the TN-201 gene therapy’s safety profile is the main objective of the MyPEAK-1 study. According to Tenaya Therapeutics, the treatment showed no unanticipated negative events and a satisfactory tolerability profile at a dose of 3E13 vg/kg.
Encouragingly, the Data and Safety Monitoring Board (DSMB) has recommended progressing to dose escalation and has endorsed the expansion of eligibility criteria, allowing Tenaya to investigate TN-201’s effectiveness in diverse patient populations. Protocol adjustments have been made, including a baseline biopsy and an increased participant pool, which now includes patients with obstructive HCM.
Future Developments
The initial dosing of the first three patients in Cohort 1 at the 3E13 vg/kg dose has been successfully completed, with no significant adverse events reported. The DSMB’s review confirmed a safety and tolerability profile consistent with existing AAV gene therapies at this dosage. Following this, enrollment for Cohort 2 is currently underway, which will escalate the dosage to 6E13 vg/kg.
Tenaya Therapeutics anticipates sharing initial data from Cohort 1 in December, focusing on safety, tolerability, cardiac biopsy analyses, and changes in cardiac biomarkers. Additionally, TNYA’s MyPEAK-1 trial aims to gather comprehensive data on TN-201’s impact on imaging biomarkers, heart function, exercise capacity, functional status, and overall patient quality of life.
