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Investing.com -- Tenaya Therapeutics Inc (NASDAQ:TNYA) stock climbed 4.2% following positive safety endorsements from independent monitoring boards for its two cardiovascular gene therapy clinical trials.
The clinical-stage biotechnology company announced that Data Safety and Monitoring Boards (DSMBs) have approved the continuation of both the MyPEAK-1 trial for TN-201 and the RIDGE-1 trial for TN-401 according to protocol. The endorsements allow Tenaya to proceed with expansion cohorts for TN-201 and to both expand at the current dose and escalate to a higher dose level for TN-401.
"Safety is paramount, and this milestone reinforces the favorable tolerability profile emerging for both TN-201 and TN-401 and highlights the appropriateness of our immunosuppressant regimen to manage patients," said Whit Tingley, Tenaya’s Chief Medical (TASE:BLWV) Officer.
For the MyPEAK-1 Phase 1b/2 trial, which targets MYBPC3-associated hypertrophic cardiomyopathy, the DSMB review followed enrollment of the first three patients at the 6E13 vg/kg dose (Cohort 2). The board determined that TN-201 has an acceptable safety profile to allow enrollment of expansion cohorts at either the 3E13 vg/kg or 6E13 vg/kg dose levels.
Initial data from the first three patients in Cohort 1 showed that TN-201 reached cardiomyocytes with robust RNA expression. Increased MyBP-C protein levels were observed in two patients with serial biopsies available. All three patients achieved New York Heart Association Class I post-treatment, indicating resolution of heart failure symptoms.
For the RIDGE-1 trial, which targets PKP2-associated arrhythmogenic right ventricular cardiomyopathy, the DSMB endorsed dose escalation to the 6E13 vg/kg level after reviewing data from the first three patients at the 3E13 vg/kg dose.
Tenaya plans to report longer-term follow-up data from the MyPEAK-1 trial’s Cohort 1 and initial data from Cohort 2 in the fourth quarter of this year. Initial data from the RIDGE-1 trial’s Cohort 1 is expected in the fourth quarter of 2025.
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