On May 16, 2016, we announced topline results from the BLAST-AHF, a Phase 2b clinical trial to evaluate the safety and efficacy of TRV027 in AHF. This randomized, double-blind, standard of care controlled trial enrolled approximately 620 patients with AHF, and compared TRV027 plus standard heart failure therapy versus placebo plus standard therapy. The study evaluated the effects of TRV027 on a composite of clinically important outcomes including length of hospital stay, worsening heart failure, dyspnea, and mortality and re-hospitalization after 30 days. As announced on May 16, the trial failed to meet either the primary or secondary endpoints, and the company expects to discontinue work on TRV027 in AHF. Data were presented at the 2016 European Society of Cardiology Heart Failure Meeting, and are available to download now.
The Phase 2a study, which was completed in 2012, was a randomized, double-blind, placebo-controlled, dose-titration study to evaluate the safety, tolerability, pharmacokinetics, and hemodynamics of TRV027 in patients with advanced stable heart failure. In this study, TRV027 decreased both mean arterial pressure and pulmonary capillary wedge pressure. No TRV027 related serious adverse events were reported. Data from the study were presented at the American College of Cardiology meeting in March 2013.
A Phase 1 clinical study of TRV027 was successfully completed in 2010. This was a single-dose escalation study to assess safety, tolerability and pharmacokinetics. TRV027 was generally well-tolerated with linear dose-related increases in exposure. Data from the study were presented as a poster at the Heart Failure Society of America Meeting in September 2012.
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