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.
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