Trevena, Inc., a clinical stage pharmaceutical company involved in the discovery and development of G-protein coupled receptor (GPCR) biased ligands, announced today initiation of dosing in BLAST-AHF, the Company's randomized, multi-center Phase 2b trial of TRV027 in patients with acute heart failure (AHF). TRV027 is a novel beta-arrestin biased ligand of the angiotensin II type 1 receptor that is being developed as a first-line intravenous treatment in combination with standard diuretic therapy for AHF patients. Trevena has granted Forest Laboratories (NYSE:FRX) an exclusive option to license TRV027 under the companies' May 2013 Option and Licensing Agreements.
"There is a significant need for new treatment options in acute heart failure, in particular for therapies that have an impact on the underlying biology of the heart failure syndrome itself. In some cases, existing treatments may actually perpetuate the underlying pathophysiology of the disease," stated Michael Felker M.D., chief of the heart failure section at the Duke University Medical Center, and scientific steering committee co-chair for this study. "TRV027 represents a promising approach for treating AHF in the hospital emergency department, with rapid onset, reversible effects on blood pressure, and specificity of its mechanism for the syndrome," added Peter Pang M.D., associate professor in emergency medicine and cardiology, Northwestern University Feinberg School of Medicine, and scientific steering committee co-chair for the study.
The randomized, double-blind, standard of care controlled, Phase 2b BLAST-AHF trial is designed to enroll at least 500 patients with AHF, and will compare TRV027 plus standard heart failure therapy versus placebo plus standard therapy. The primary objective of this trial is to evaluate the effects of three dose levels of TRV027, 1.0 mg/hr, 5.0 mg/hr and 25 mg/hr, on a composite of clinically important outcomes: mortality, worsening heart failure, hospital readmission rate, dyspnea, and length of hospital stay. In this study, TRV027 or placebo will be initiated soon after presentation to the hospital, and will then continue to be administered for a minimum of 48 hours and up to 96 hours.
"The initiation of BLAST-AHF represents another significant milestone in our efforts to rapidly translate our groundbreaking research on biased ligands into differentiated treatments with improved efficacy and safety profiles," stated Maxine Gowen, Ph.D., president and chief executive officer of Trevena. "With this study, we are building on earlier data demonstrating the potential of TRV027 to rapidly reduce blood pressure and, unlike current therapies, promote beneficial effects on the three key organ systems affected during acute heart failure - the blood vessels, kidneys and heart. We look forward to advancing the BLAST-AHF trial and expect data to be available in the second half of 2015."