Tenaya Therapeutics, Inc. ((TNYA)) announced an update on their ongoing clinical study.
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Tenaya Therapeutics, Inc. is conducting a pivotal clinical study titled ‘First-in-Human, Open-Label, Safety, Tolerability, Dose-Finding, Pharmacodynamic and Cardiac Transgene Expression Study of TN-401, a Recombinant Adeno-associated Virus Serotype 9 (AAV9) Containing Plakophilin-2 (PKP2) Transgene, in Adults With PKP2 Mutation-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)’. The study aims to assess the safety and preliminary efficacy of TN-401 gene therapy in adults with PKP2 mutation-associated ARVC, a significant step in addressing this genetic heart condition.
The intervention being tested is TN-401, a genetic therapy delivered via a single intravenous dose. TN-401 utilizes a recombinant adeno-associated virus serotype 9 (AAV9) to deliver the Plakophilin-2 (PKP2) transgene, potentially offering a novel treatment for ARVC.
This Phase 1 study is interventional, non-randomized, and follows a sequential intervention model without masking. The primary purpose is treatment, focusing on determining the appropriate dosage and observing initial safety and efficacy outcomes.
The study began on January 18, 2024, with its latest update submitted on February 5, 2025. These dates are crucial as they mark the study’s progress and ongoing recruitment status, indicating active development and potential future milestones.
For investors, this study could influence Tenaya Therapeutics’ stock performance, especially if TN-401 shows promising results. The gene therapy market is competitive, and successful outcomes could position Tenaya favorably against its peers, enhancing investor confidence.
The study is currently recruiting, with further details available on the ClinicalTrials portal.