Tenaya Therapeutics announces anticipated 2023 milestones

2023 Anticipated Milestones and Recent Progress: TN-201 – MYBPC3 Gene Therapy Program for Genetic Hypertrophic Cardiomyopathy: Tenaya anticipates dosing the first patient in the Phase 1b clinical trial of TN-201 in the third quarter 2023, Initial data from the TN-201 Phase 1b clinical trial is anticipated in 2024. TN-301 – Small Molecule HDAC6 Inhibitor for Heart Failure with Preserved Ejection Fraction: The company expects to commence dosing in the multiple-ascending dose stage of the Phase 1 trial in the first quarter 2023. Tenaya plans to present clinical data from both the SAD and MAD stages of the Phase 1 clinical trial in the second half 2023. The company expects to also present additional preclinical data supporting the efficacy of TN-301, the mechanism of action of HDAC6 inhibition, and comparisons with SGLT2 inhibitors at major conferences in 2023. TN-401 – PKP2 Gene Therapy Program for Genetic Arrhythmogenic Right Ventricular Cardiomyopathy: Tenaya plans to submit an IND application to the FDA in the second half 2023 to enable clinical development of TN-401. Clinical supply of TN-401 will be produced at Tenaya’s cGMP Genetic Medicines Manufacturing Center to support the IND filing. These efforts leverage significant learnings from related nonclinical, regulatory, clinical and manufacturing efforts for TN-201. Early-stage Research Efforts: Tenaya plans to present and publish new preclinical data related to its research on new targets, novel AAV capsid engineering efforts and manufacturing process improvements throughout 2023.