Tenaya Therapeutics Gets FDA Clearance To Begin Clinical Testing Of TN-401 Gene Therapy

(RTTNews) - Tenaya Therapeutics, Inc. (TNYA) announced the U.S. Food and Drug Administration has provided clearance of the company's Investigational New Drug application to initiate clinical testing of TN-401. TN-401 is adeno-associated virus serotype 9-based investigational gene therapy product candidate for the treatment of arrhythmogenic right ventricular cardiomyopathy caused by mutations in the plakophilin-2 gene.

Based on the IND clearance, the company plans to begin the RIDGE-1 Phase 1b clinical trial of TN-401, a multi-center, open-label study to assess the safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-401.

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