TN-301 / Tenaya Therap - LARVOL DELTA

Co-Administration of Inhibitors of HDAC6 and SGLT2 in Murine HFpEF Models Results in Additive Improvements in Cardiac Structural and Functional Measures (HFSA 2023) - "TN-301, a highly selective HDAC6 inhibitor has been advanced into clinical development for the potential treatment of HFpEF.Purpose In this study, we sought to investigate the additive or synergistic effects of combining HDAC6 and SGLT2 inhibition to improve cardiac function in a two-hit mouse model of HFpEF.Methods and Results Low doses of TYA-018 (a highly selective HDAC6 inhibitor) and empagliflozin were co-administered in our HFpEF model. Gene expression analysis is being conducted using RNA-seq to elucidate the potential mechanisms underlying the efficacy of HDAC6 and SGLT2 inhibition by characterizing the pathway-level modulation by combination treatment compared to each therapy alone. Results of gene expression analysis comparing single-agent and combination activity are planned for inclusion at the time of presentation.Conclusion These studies demonstrate an additive benefit on diastolic dysfunction and elucidate key molecular mechanisms supporting the rationale..."

Preclinical • Cardiovascular • Congestive Heart Failure • Heart Failure • Inflammation

Phase 1 Clinical Trial Of TN-301, A Highly Selective HDAC6 Inhibitor With Potential In HFPEF, Shows Target Engagement (HFSA 2023) - "Initial data from This FiH clinical trial of TN-301 in healthy adult participants demonstrated clear evidence of target engagement. To date, TN-301 has been generally well tolerated with PK consistent with once-daily dosing. TN-301 represents a promising new therapeutic candidate for the potential treatment of HFpEF and other indications."

Clinical • P1 data • Cardiovascular • Congestive Heart Failure • Fibrosis • Heart Failure • Immunology • Inflammation • Metabolic Disorders

Tenaya Therapeutics to Present Data for TN-301 and TN-201 at Upcoming Medical Conferences (GlobeNewswire) - "Tenaya Therapeutics...announced today that poster presentations related to its TN-201 and TN-301 programs will be presented at the 2023 Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions taking place October 6, 2023, and at the Heart Failure Society of America (HFSA) Annual Scientific Meeting occurring October 6-9, 2023....Data to be presented at HFSA will include results from the company’s Phase 1 clinical trial of TN-301 in healthy adult participants....The company will also present new data from preclinical studies examining the effects of its HDAC6 inhibitor in combination with an approved HFpEF treatment in a model of disease....Tenaya will highlight the clinical trial design for its Phase 1b clinical trial in nonobstructive patients with MYBPC3-associated HCM as well as sharing interim data from an ongoing seroprevalence study."

P1 data • Preclinical • Cardiomyopathy • Cardiovascular • Heart Failure • Hypertrophic Cardiomyopathy

Tenaya Therapeutics Announces TN-201 IND Clearance and Anticipated 2023 Milestones (GlobeNewswire) - "Tenaya Therapeutics...announced today that the U.S. Food and Drug Administration (FDA) has provided clearance of its Investigational New Drug (IND) application to initiate clinical testing of TN-201. In addition, Tenaya shared anticipated 2023 program milestones and updated cash runway guidance....'We are pleased to start 2023 with clearance of the IND for our TN-201 gene therapy program and look forward to dosing patients with MYBPC3-associated HCM in our Phase 1b study in the coming months. We are also starting 2023 with confirmation of target engagement in our TN-301 Phase 1 study and look forward to reporting clinical data for this program later this year.'"

IND • New P1 trial • P1 data • Cardiomyopathy • Cardiovascular • Hypertrophic Cardiomyopathy