Tenaya Therapeutics Announces FDA Clearance of Investigational New Drug Application and Initiation of Phase 1 Safety Study for TN-301, an HDAC6 Inhibitor for Heart Failure with Preserved Ejection Fraction

About this update from Tenaya Therapeutics, Inc.

[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., Sept. 06, 2022 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, announced clearance of its Investigational New Drug (IND) application to begin clinical testing of TN-301 by the U.S. Food and Drug Administration (FDA). TN-301 is Tenaya’s highly selective small molecule inhibitor of histone deacetylase 6 (HDAC6), initially being developed for the potential treatment of heart failure with preserved ejection fraction (HFpEF). Tenaya has initiated its first-in-human Phase 1 clinical trial of TN-301 in healthy adult participants. “HFpEF accounts for approximately half of all heart failure cases and its prevalence is increasing, yet there are few effective treatment options. We are excited by the prospects for TN-301, which has shown compelling promise in preclinical models of HFpEF by improving left ventricular relaxation and filling, a hallmark of the disease,” said Whit Tingley, M.D., Ph.D., Tenaya’s Chief Medical Officer. “The FDA clearance of our IND application for TN-301 is an important milestone for Tenaya as we transition to a clinical-stage biotechnology company and advance the first of our internally discovered candidates to address heart disease into first-in-human safety studies. In conjunction with IND clearance, we have initiated the Phase 1 clinical study of TN-301.” HFpEF is a complex syndrome with many contributing causal factors and is estimated to affect more than three million people in the U.S. alone.1 It is a disease that involves systemic inflammation, left ventricular hypertrophy, fibrosis, and diastolic dysfunction, resulting in high morbidity and mortality. In preclinical studies, Tenaya’s proprietary HDAC6 inhibitors have shown evidence of improvements in multiple parameters of HFpEF, including reducing inflammation, normalizing metabolic dysfunction and improving diastolic dysfunction2, all of which have been linked to the pathogenesis of the disease. The IND clearance was based on preclinical studies that characterized the safety and mechanistic profile of TN-301. Tenaya’s Phase 1 randomized, double-blind, placebo-controlled clinical study is designed to evaluate the safety and tolerability of escalating oral do...

More updates from Tenaya Therapeutics, Inc.