Tenaya Therapeutics reports positive data from RIDGE-1 Phase 1b/2 trial of TN-401 in PKP2-associated ARVC

Tenaya Therapeutics (NASDAQ:TNYA), a clinical-stage biotechnology company developing gene therapies for heart disease, reported positive interim data from the first two cohorts of its ongoing RIDGE-1 Phase 1b/2 trial of TN-401 in patients with PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC).

All six treated adults showed meaningful reductions in PVC burden, with a mean reduction of 64% from baseline.

TN-401 was generally well tolerated at the 3E13 vg/kg and 6E13 vg/kg dose levels.

Cardiac biopsies provided evidence of successful transduction in the heart tissue.

Separately, TN-401 has been granted Priority Medicines (PRIME) designation by the European Medicines Agency, which provides enhanced support for the development and accelerated assessment of medicines targeting unmet medical needs.