TransThera Biosciences Announces IND Approval from FDA for Clinical Studies of TT-00920 to Treat Chronic Heart Failure

TransThera Biosciences Co. Ltd, a clinical-stage biotechnology company based in Nanjing, China, announced today that the U.S. Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for TT-00920, a novel small molecule inhibitor of Phosphodiesterase 9 (PDE 9) for the treatment of chronic 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.

"IND approval for TT-00920 is an important milestone for TransThera," said Dr. Frank Wu, Founder and CEO of TransThera. "We believe that TT-00920 has potential to be a new transformative treatment option for patients suffering from chronic heart failure, particularly for HFpEF (heart failure with persevered ejection fraction), a predominant form of heart failure with no disease-modifying treatment options. We look forward to working with patients and physicians to evaluate the potential of TT-00920 in clinic."

About TT-00920

TT-00920 is an investigational, 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. Compelling preclinical data demonstrates that TT-00920 strongly enhanced cardiac function and reversed ventricular remodeling 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.

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