TransThera Biosciences announced the U.S. FDA has approved the company’s Investigational New Drug (IND) application for TT-00920 for the treatment of chronic heart failure. Preclinical data demonstrated that TT-00920 strongly enhanced cardiac function and reversed ventricular remodeling in heart failure.
Under this IND, TransThera will initiate a Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TT-00920 in healthy volunteers. The trial is expected to initiate in early 2020.
TT-00920 is a highly potent and selective PDE9 inhibitor for the treatment of chronic heart failure. PDE9 protein interferes with a body’s natural “braking” system needed to neutralize stress on the heart and has shown to be markedly elevated in heart failure, particularly in HFpEF. Inhibiting PDE9 with TT-00920 restores the cardio-protective mechanism that is dysfunctional in heart failure.
About Heart Failure
Chronic heart failure (CHF) is a chronic, progressive clinical syndrome that results from structural or functional impairment of ventricular filling or ejection of blood. It is a global problem with increasing prevalence due to an aging population worldwide with increasing co-morbidities. The current global prevalence of heart failure is estimated to be more than 26 million people. While current therapies have helped to improve patient outcomes, CHF remains the leading cause of hospitalization for those over the age of 65 and represents a significant clinical and economic burden.