Tenaya Therapeutics Says FDA Clears IND Application And Initiation Of Phase 1 For TN-301

(RTTNews) - Biotechnology company Tenaya Therapeutics, Inc. (TNYA) announced Tuesday the 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.

Tenaya's Phase 1 randomized, double-blind, placebo-controlled clinical study is designed to evaluate the safety and tolerability of escalating oral doses of TN-301. Secondary objectives of the study will be to assess pharmacokinetics and pharmacodynamics (PD) measures.

The Phase 1 trial will enroll healthy adult participants in two stages. In Stage 1, participants will receive single ascending doses (SAD) of either TN-301 or placebo.

Based on emerging data from the SAD portion of the study, including PD evidence of target engagement, participants in Stage 2 will receive multiple ascending doses of TN-301 at dose levels of interest to help guide dosing in future studies.

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