TRV027 Phase 2b BLAST-AHF Trial Design Published in Journal of the American College of Cardiology: Heart Failure
- Study Assesses Key Clinical Measures Targeted by TRV027 in Acute Heart Failure -
Feb. 3, 2015 12:00 UTC
KING OF PRUSSIA, Pa.--(BUSINESS WIRE)-- Trevena, Inc. (NASDAQ:TRVN), a clinical stage biopharmaceutical company focused on the discovery of G protein coupled receptor (GPCR) biased ligands, today announced publication of the trial design for its ongoing Phase 2b study of TRV027 in acute heart failure (AHF) in the Journal of the American College of Cardiology: Heart Failure. The abstract of the manuscript, entitled "Heart Failure Therapeutics Based on a Biased Ligand of the Angiotensin-2 Type 1 Receptor: Rationale and Design of the BLAST-AHF (Biased Ligand of the Angiotensin Receptor Study in Acute Heart Failure) Study," can be viewed online at the JACC:HF website, http://heartfailure.
"Previous data suggest that TRV027 can, unlike other therapies, directly target AHF pathophysiology, with potentially beneficial effects on blood vessels, kidneys and heart," stated Peter Pang, MD, Associate Professor of Emergency Medicine at Indiana University and co-Chair of the BLAST-AHF Steering Committee. "These three key organ systems drive clinical outcomes in acute heart failure, where mortality and re-hospitalization rates continue to remain unacceptably high. We know from decades of treating chronic heart failure with ARBs and ACE inhibitors that these three organ systems can be successfully modulated by targeting the angiotensin-2 type 1 receptor – but only TRV027 has a profile suggesting potential use in treating acute heart failure."
"The BLAST-AHF trial is testing the impact of TRV027 on a range of important clinical measures in acute heart failure using an innovative composite endpoint," said G. Michael Felker, MD, Professor of Medicine and Chief of the Heart Failure Section of Cardiology at the Duke University School of Medicine, and co-Chair of the BLAST-AHF Steering Committee. "Current therapies are not proven and can worsen the angiotensin-mediated pathophysiology driving AHF. TRV027, with its novel mode of action, directly targets this core pathophysiology, which may improve patient outcomes. Positive results from this study would help inform the optimal design of registration studies."
About the ongoing Phase 2b BLAST-AHF trial
BLAST-AHF is a randomized, double-blind, standard of care controlled trial that will enroll approximately 500 patients with AHF. 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 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. Over 250 patients have been recruited to date. The BLAST-AHF Steering Committee is currently conducting an interim evaluation of the safety and efficacy data from the first 250 patients enrolled in the study. As planned, this evaluation may lead to the discontinuation of one or two TRV027 doses and focus future recruitment into the dose arm(s) that show the most promise. Trevena currently expects to report data from this trial by the end of the fourth quarter of 2015.
TRV027 is an investigational peptide drug in a Phase 2b trial for the treatment of AHF. It targets the angiotensin II type 1 receptor, a key driver of AHF, with an innovative "biased ligand" mechanism that simultaneously vasodilates while increasing cardiac performance. This profile suggests that TRV027 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 is developing four biased ligand product candidates it has identified - TRV027 to treat acute heart failure (Phase 2b), TRV130 to treat moderate to severe acute pain intravenously (Phase 2b), TRV734 to treat moderate to severe acute and chronic pain orally (Phase 1), and TRV250 for treatment-refractory migraine (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: the status, timing, costs, results and interpretation of the company's clinical trials, including when enrollment in the Phase 2b trial will conclude and when data will be reported; 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, including whether (i) TRV027 can, unlike other therapies, directly target AHF pathophysiology, with potentially beneficial effects on blood vessels, kidneys and heart and patient outcomes, (ii) positive results from the Phase 2b study would help inform the optimal design of registration studies and (ii) TRV027 has the potential to become an important new therapy for AHF patients; 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; the inherent uncertainties associated with intellectual property; 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, 610-354-8840 x231
Director of Investor Relations
Andrea Rabney, 212-600-1902
President and Chief Executive Officer
Eliza Schleifstein, 917-763-8106
Source: Trevena, Inc.