Thryv Therapeutics Receives FDA IND Clearance of THRV-1268 for Clinical Programs in Heart Failure and Atrial Fibrillation and Presents Results of SGK1 Inhibition Combined with Jardiance (empagliflozin), an SGLT2 inhibitor, in a Pressure Overload Heart Failure Model at ESC Congress 2025

MONTREAL, Sept. 8, 2025 /CNW/ - Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing a series of novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for cardiovascular diseases, today announced the presentation of preclinical results demonstrating improvements in adverse cardiac remodeling beyond empagliflozin (EMPA) by reducing inflammation and fibrosis mechanisms in heart failure.  These findings were presented by Saumya Das, MD, PhD, Co-Director of the Resynchronization and Advanced Cardiac Therapeutics Program at Massachusetts General Hospital, at the European Society of Cardiology (ESC) Congress 2025, held in Madrid, Spain.  

In addition, Thryv is pleased to announce the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to initiate its clinical program in heart failure (HF) and atrial fibrillation.

New Preclinical Data Presented at ESC 2025
On August 31, 2025, Thryv presented new preclinical data from a pressure overload HF model at ESC Congress. This in vivo study evaluated the effects of THRV-1268, both as a monotherapy and in combination with empagliflozin (Jardiance®), an SGLT2 inhibitor, in a transverse aortic constriction (TAC) model.

Results demonstrated that treatment with THRV-1268, alone or in combination with Jardiance, improved mechanical and structural function over vehicle and Jardiance alone, as measured by left ventricular ejection fraction, end systolic volume, and posterior wall thickness.

Biomarker analyses demonstrated that THRV-1268 attenuated the dysregulation of pro-inflammatory, pro-fibrotic, and metabolic pathways beyond Jardiance in this model.

The combination of THRV-1268 with Jardiance represents a promising potential therapeutic strategy for patients with heart failure. A Phase 1 study (NCT06507839) evaluating the safety, tolerability and pharmacokinetics of THRV-1268 demonstrated that the compound was well-tolerated with predictable pharmacokinetics.

IND Clearance of THRV-1268 for the Heart Failure and Atrial Fibrillation Clinical Programs
Thryv announced that it has received a Study May Proceed letter from the FDA for its IND application to evaluate THRV-1268 in obese healthy volunteers and screening for that study has begun.

"This IND clearance represents a significant milestone for Thryv as we transition into mid-stage clinical development," said Debra Odink, PhD, President and Chief Development Officer of Thryv. "The FDA's agreement for us to proceed with the Phase 1 clinical investigation is an important step towards the goal of advancing THRV-1268 into Phase 2 proof of efficacy studies, where we aim to demonstrate its potential as a novel, mechanism-based therapy for patients living with heart failure and atrial fibrillation."

The role of SGK1 inhibition in mediating beneficial structural and electrical remodeling well suits the company's plans to initiate the Phase 2 proof of efficacy Aspire study in heart failure and obesity-associated paroxysmal atrial fibrillation in 2026.

About Thryv Therapeutics
Thryv Therapeutics Inc. is a privately owned company based in Montreal, Quebec, Canada. Thryv is pioneering a precision medicine approach to treat Long QT Syndrome, heart failure and atrial fibrillation with potent and highly selective inhibitors of serum glucocorticoid inducible kinase 1 (SGK1).  For more information, please visit www.thryvtrx.com.   

SOURCE Thryv Therapeutics Inc.

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