Trevena ($TRVN) has delivered a double dose of bad news for its acute heart failure candidate TRV027 as it failed to hit either its primary or secondary endpoints.
Specifically, the Phase IIb BLAST-AHF study in acute heart failure saw the drug fail its primary objective of: improving mortality, worsening heart failure, hospital readmission rate, dyspnea and length of hospital stay when compared to placebo.
In the midstage study, either TRV027 or placebo were given to patients after being hospitalized and then continued to be administered for a minimum of 48 hours and a maximum of 96 hours.
David Soergel, chief medical officer of the King of Prussia, PA-based biotech, said: “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.
“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,” added Maxine Gowen, Trevena’s CEO.
The company said it now expects “to focus its efforts on its lead Phase III oliceridine pain program and its earlier stage programs.” Oliceridine, its lead candidate, was recently granted a breakthrough therapy status from the FDA.
The drug, which works as a non-opioid, is given as an intravenous therapy that modulates the body's mu opioid receptors to relieve pain without respiratory and gastrointestinal side effects that limit other agents, according to the company.
In a pair of recent Phase II trials, Trevena's drug beat placebo and measured up to morphine in postsurgery patients, notching significantly lower rates of vomiting, nausea and breathing problems compared with morphine.
The biotech’s platform targets G protein coupled receptors, or GPCRs, and currently has three biased ligand product candidates: oliceridine (TRV130) to treat moderate to severe acute pain; TRV734 to treat moderate to severe acute and chronic pain orally (in Phase I); and TRV250 for acute episodic migraine and other CNS disorders (preclinical).
The company was more than 2.5% down at 8 a.m. EDT this morning.
- check out the release