Trevena Highlights Phase 2b-BLAST AHF Trial for TRV027 at the European Society of Cardiology Heart Failure 2014 Meeting

KING OF PRUSSIA, Pa.--(BUSINESS WIRE)-- Trevena, Inc. (NASDAQ: 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.

About TRV027

TRV027 is an investigational peptide drug in Phase 2b trials for the treatment of heart failure (AHF). It targets the angiotensin II type 1 receptor, a key driver of AHF, with an innovative “biased ligand” mechanism which simultaneously vasodilates while increasing cardiac performance. This profile has the potential to become an important new therapy for AHF patients.

About Trevena

Trevena, Inc. is a clinical stage biopharmaceutical company that discovers, develops and intends to commercialize therapeutics that use a novel approach to target G protein coupled receptors, or GPCRs. Using its proprietary product platform, Trevena has identified and advanced three differentiated biased ligand product candidates into the clinic – TRV027 to treat acute heart failure, TRV130 to treat moderate to severe acute pain intravenously, and TRV734 to treat moderate to severe acute and chronic pain orally. Trevena also plans to advance additional product candidates in its portfolio, including a preclinical program focused on central nervous system indications.

Cautionary Note on Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, its future operations, clinical development of its therapeutic candidates, potential therapeutic utility for its product candidates, market opportunities for its product candidates, its plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: availability and timing of data from ongoing clinical trials, the uncertainties inherent in the initiation of future clinical trials, whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical trials will be indicative of the results of future trials, expectations for regulatory approvals, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates and other factors discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the Securities and Exchange Commission on March 20, 2014 and other filings the Company makes with the Securities and Exchange Commission from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

Investor Contacts:
Trevena, Inc.
Jonathan Violin
Director of investor relations
610-354-8840 x231
jviolin@trevenainc.com
or
Argot Partners
Andrea Rabney
President and chief executive officer
212-600-1902
andrea@argotpartners.com
or
Media Contact:
Argot Partners
Eliza Schleifstein
917-763-8106
eliza@argotpartners.com

Source: Trevena, Inc.

Released May 19, 2014