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Trevena (TRVN) Announces TRV027 Phase 2b BLAST-AHF Missed Primary, Secondary Endpoints

May 16, 2016 7:02 AM EDT

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Trevena, Inc. (NASDAQ: TRVN) announced that the company’s TRV027 failed to meet either the primary or secondary endpoints in the Phase 2b BLAST-AHF study in acute heart failure (AHF). The company expects to focus its efforts on its lead Phase 3 oliceridine pain program and its earlier stage programs.

“We are very disappointed that TRV027 failed to show the hoped for benefits to patients in the BLAST-AHF study. We will continue to analyze the data to further understand the outcome, but believe the study was well conducted and has answered the questions it was designed to test,” said David Soergel, M.D., chief medical officer. “We are extremely grateful to the patients and investigators who participated in the trial.”

“It is always disappointing when an investigational product fails to support a promising hypothesis in a clinical trial,” said Maxine Gowen, Ph.D., chief executive officer. “We remain confident in our Phase 3 oliceridine program, which has been granted Breakthrough Therapy designation by the FDA, as well as our earlier stage opportunities and platform, and we remain committed to bringing innovative new medicines to patients to treat serious medical needs.”

Data from the BLAST-AHF trial will be presented in a late-breaking trials session scheduled for 2:15-3:45pm CEST on Saturday, May 21 at Heart Failure 2016, the annual congress of the Heart Failure Association of the European Society of Cardiology.

About the Phase 2b BLAST-AHF trial

BLAST-AHF was a randomized, double-blind, standard of care controlled trial in 618 patients with acute heart failure. The study compared 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 was 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. Pre-specified analyses to identify populations that may respond best to TRV027 included segmentation by ejection fraction, systolic blood pressure, plasma renin activity, and glomerular filtration rate. The study methodology was published in the Journal of the American College of Cardiology – Heart Failure in March 2015.



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