Trevena Completes Phase 2a Study of TRV027 in Patients with Advanced Heart Failure
TRV027 improves hemodynamics and is well-tolerated in patients with stable advanced heart failure, supporting advancement into a Phase 2b study in ADHF
KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Oct 8, 2012 - Trevena, Inc., the leader in the discovery and development of G-protein coupled receptor (GPCR) biased ligands, today announced that it has successfully completed a Phase 2a study on the hemodynamic effects of TRV027 in patients with advanced heart failure with reduced ejection fraction. TRV027 was generally well-tolerated in this study and produced beneficial hemodynamic effects in line with those observed in previously published pre-clinical studies. Trevena is developing TRV027 for the intravenous hospital treatment of acute decompensated heart failure (ADHF), and these data support the advancement of TRV027 into a future study to evaluate its clinical efficacy in patients with ADHF.
Dr. G. Michael Felker, Associate Professor of Medicine at Duke University, commented that “The data from this study suggest that TRV027 is safe, and that its pharmacology in patients with heart failure is consistent with that shown in preclinical studies. We are looking forward to studying the effects of this exciting new therapy in patients suffering with acute heart failure, where we desperately need new therapeutic alternatives.” Dr Felker is a member of the steering committee for clinical development of TRV027.
The Phase 2a study is a randomized, double-blind, placebo-controlled, adaptive, ascending dose-titration study to evaluate the safety, tolerability, pharmacokinetics, and invasive hemodynamics of TRV027 in patients with stable NYHA Class 3 and 4 heart failure. Thirty-three catheterized patients were enrolled at centers in the US and Europe. Twenty-four patients received TRV027 and 9 patients received placebo.
TRV027 rapidly and reversibly decreased both blood pressure and pulmonary capillary wedge pressure, which is linked to dyspnea in acute heart failure. In the background of these blood pressure effects, TRV027 preserved kidney function, as measured by creatinine and cystatin C, which is of critical importance in acute heart failure. TRV027 also preserved cardiac output. No drug-related serious adverse events were reported, consistent with the safety profile seen in preclinical studies. These findings demonstrate the safety and anticipated pharmacology of TRV027 in patients with advanced heart failure. Data from the study will be presented at an upcoming scientific conference.
ADHF represents a serious challenge for patients, physicians and healthcare systems. The American Heart Association estimated that ADHF hospitalization costs the U.S. healthcare system more than $20 billion each year in direct spending. ADHF is already the leading reason for hospitalization of individuals over 65 years old in the United States, with over 1 million hospital admissions per year. ADHF is also the most costly diagnosis for Medicare. Despite the significance of this problem, current therapies are not producing meaningful improvements in patient outcomes. ADHF incidence is increasing globally, and both heart failure mortality and hospital re-admission following an ADHF event remain extremely high. There is an urgent need for better treatments, and a clear incentive for regulators and payers to approve and reimburse them.
About Trevena and Biased Ligands
Trevena, Inc. is a clinical stage pharmaceutical company focused on discovering and developing the next generation of G-protein coupled receptor (GPCR) targeted medicines. GPCRs are the targets for at least one-third of modern medicinal products, and remain the predominant class of targets under clinical evaluation. Trevena's expertise lies in engineering “biased ligands” that activate only the beneficial signaling pathways downstream of a GPCR to unlock new biology and avoid drug adverse effects. In addition to TRV027, Trevena's pipeline currently includes a clinical stage mu-opioid biased ligand for post-operative pain, and discovery-stage programs for chronic pain, and Parkinson's disease. Trevena is based in King of Prussia, Pennsylvania and is backed by leading investors including Alta Partners, Healthcare Ventures, NEA, Polaris and Yasuda Enterprise Development Company. For more information about the company, please visit www.trevenainc.com.
Posted: October 2012