Trevena Announces BLAST-AHF Phase 2b Trial Results will be Presented at the Heart Failure 2016 Conference
KING OF PRUSSIA, Pa.--(BUSINESS WIRE)-- Trevena, Inc. (NASDAQ: TRVN), a clinical stage biopharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors, today announced that results from its BLAST-AHF Phase 2b study of TRV027 in acute heart failure (AHF) will be presented at Heart Failure 2016, the annual congress of the Heart Failure Association of the European Society of Cardiology. Heart Failure 2016 includes the 3rd World Congress on Acute Heart Failure, and is taking place in Florence, Italy, May 21-24, 2016.
Enrollment and 30 day follow-up for the trial are now complete, and the company expects to receive data in May. Results of the trial will be presented in a late-breaking trials session scheduled for 2:15-3:45pm CEST on Saturday May 21. The presentation will be made by G. Michael Felker, M.D., Professor of Medicine at Duke University Medical Center and co-chair of the BLAST-AHF Steering Committee.
About the ongoing Phase 2b BLAST-AHF trial
BLAST-AHF is a randomized, double-blind, standard of care controlled trial in approximately 620 patients with acute heart failure. The study methodology was published in the Journal of the American College of Cardiology – Heart Failure in March 2015. The study is comparing 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 were initiated after presentation to the hospital and then continued to be administered for a minimum of 48 hours and a maximum of 96 hours. After a pre-specified interim analysis after approximately 250 patients were enrolled, enrollment was weighted towards the most promising dose of 5.0 mg/hr. Final enrollment is expected to be approximately 185 patients per arm for the placebo and the 5.0 mg/hr dose, and 125 patients per arm for the 1.0 mg/hr and 25.0 mg/hr doses.
TRV027 targets the angiotensin II type 1 receptor, a key driver of AHF, with an innovative “biased ligand” mechanism that protects the heart, kidneys and vasculature. This profile has the potential to become an important new therapy for AHF patients.
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 four biased ligand product candidates – oliceridine (TRV130) to treat moderate to severe acute pain intravenously (Phase 3), TRV027 to treat acute heart failure (Phase 2b), TRV734 to treat moderate to severe acute and chronic pain orally (Phase 1), and TRV250 for acute episodic migraine and other CNS disorders (preclinical).
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, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “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: uncertainties related to the Company’s intellectual property; the status, timing, costs, results and interpretation of the Company’s clinical trials, including the timing of the receipt of the BLAST-AHF study of TRV027; the uncertainties inherent in conducting 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 set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only 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, it specifically disclaims any obligation to do so, except as may be required by law.
Jonathan Violin, Ph.D.
Sr. Director, Investor Relations
Source: Trevena, Inc.
Released April 15, 2016