Trevena Presents Trial Design Rationale for Ongoing Phase 2b BLAST-AHF Study of TRV027 in AHF

Trevena, Inc. TRVN, a clinical stage pharmaceutical company focused on the discovery and development of G protein coupled receptor (GPCR) biased ligands, today announced that it presented the trial design rationale for its ongoing Phase 2b BLAST-AHF Study of TRV027 in acute heart failure (AHF) at the European Society of Cardiology Heart Failure (ESC-HF) 2014 Meeting, which is taking place May 17 – 20, 2014 in Athens, Greece. In addition, Peter Pang, M.D., associate professor of emergency medicine, Indiana University School of Medicine, and scientific steering committee co-chair for the BLAST-AHF study, highlighted TRV027 during a symposium at the meeting focused on new therapies in development for the treatment of heart failure. 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. Through its unique mechanism of action, TRV027 acts as a vasodilator while simultaneously increasing cardiac performance. “With this study, we are seeking to build on earlier data demonstrating the potential of TRV027 to promote beneficial effects on the three key organ systems affected during acute heart failure – the blood vessels, kidney and heart,” stated David Soergel, MD, senior vice president, clinical development at Trevena. “The BLAST-AHF study will evaluate TRV027 across multiple clinically relevant domains, including symptoms, in-hospital clinical course, and post-discharge outcomes, and, if positive, help to inform the optimal design of registration studies.” “The BLAST-AHF study uses an innovative design to test the impact of TRV027 on a spectrum of important clinical measures in acute heart failure, which continues to take a devastating medical and economic toll,” stated Michael Felker, MD, professor of medicine and chief of the heart failure section of cardiology at the Duke University School of Medicine. “Current therapeutic options are not proven, and can in fact exacerbate the underlying pathophysiology. TRV027, which uses a novel mode of action to target this core pathophysiology, could represent an important new treatment for AHF.” The Phase 2b BLAST-AHF protocol was outlined in a poster presentation entitled “Rationale and Design of the Biased Ligand at the Angiotensin Receptor Study in Acute Heart Failure (BLAST-AHF)”. This randomized, double-blind, standard of care controlled trial will enroll 500 patients with AHF, and will compare TRV027 (1.0 mg/hr, 5.0 mg/hr and 25 mg/hr) plus standard heart failure therapy versus placebo plus standard therapy. The primary objective of this trial is to evaluate the effects of TRV027 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 after presentation to the hospital, and will then continue to be administered for a minimum of 48 hours and a maximum of 96 hours. Trevena expects to report top-line results from the study in the second half of 2015. Downloadable copies of the poster are available on the Trevena website: www.trevenainc.com.