KING OF PRUSSIA, Pa.--()--Trevena, Inc., the leader in the discovery of G-protein coupled receptor (GPCR) biased ligands, today announced that it is presenting a poster featuring Phase 1 clinical data on TRV027 at the 16th Annual Heart Failure Society of America Meeting being held in Seattle, WA, September 9th-12th. Trevena is developing TRV027 for the treatment of acute decompensated heart failure. TRV027 is the most advanced drug in Trevena’s pipeline, and currently the subject of a Phase 2a dose finding study in stable chronic heart failure patients. The Phase 1 first-time-in-human clinical study of the drug was successfully completed in 2010.
“We are delighted to have successfully translated the safety, tolerability, pharmacokinetics, and pharmacodynamics of TRV027 from preclinical species into humans. These Phase 1 data support the decision to progress TRV027, our first biased ligand, into the current Phase 2 study in heart failure patients”
David Soergel, M.D., Head of Clinical Development at Trevena, will present the poster entitled “First human dosing experience with TRV027, a novel therapy for acute heart failure,” on Tuesday, September 11th. The Phase 1 study of TRV027 was a single-dose, dose escalation, crossover study in two cohorts of healthy subjects. The aims of the study were to assess the safety, tolerability and pharmacokinetics of TRV027 and to inform dose selection and dosing for Phase 2 studies.
“We are delighted to have successfully translated the safety, tolerability, pharmacokinetics, and pharmacodynamics of TRV027 from preclinical species into humans. These Phase 1 data support the decision to progress TRV027, our first biased ligand, into the current Phase 2 study in heart failure patients,” commented Maxine Gowen, Ph.D., President and CEO of Trevena.
About Acute Heart Failure
Acute heart failure (AHF) represents a serious challenge for patients, physicians and healthcare systems. The American Heart Association estimated that heart failure hospitalization costs the U.S. healthcare system more than $20 billion each year. AHF is already the leading reason for hospitalization of individuals over 65 years old in the United States, with an estimated 1.5 million admissions last year, and is the most costly diagnosis for Medicare. Despite the significance of this problem, current therapies are not producing meaningful improvements in patient outcomes. AHF incidence is increasing globally, and both heart failure mortality and hospital re-admission following an AHF event remain extremely high. For all of these reasons, 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 they remain the predominant class of targets under clinical evaluation. Trevena’s expertise lies in understanding which signaling pathways downstream of a GPCR are associated with beneficial versus adverse biological effects, and in engineering “biased ligands” that activate only the beneficial pathways to unlock new biology and avoid drug adverse effects. Trevena’s platform can be broadly applied across therapeutic areas and its pipeline currently includes programs in cardiovascular and CNS diseases. Founded in 2008, Trevena is based in King of Prussia, Pennsylvania and is a privately held company 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.