May 16, 2016
By Mark Terry, BioSpace.com Breaking News Staff
King of Prussia, Pennsylvania-based Trevena plans to shift its focus after its TRV027 flopped in a Phase IIb clinical trial for acute heart failure.
The BLAST-HAF trial was a randomized, double-blind, standard of care controlled trial that looked at 618 patients with acute heart failure. It studied TRV027 with standard heart failure therapy versus a placebo plus standard therapy. The primary endpoint was on a composite of clinical outcomes, including mortality, worsening heart failure, hospital readmission rate, dyspnea, and length of hospital stay. The drug did not meet primary or secondary endpoints.
“We are very disappointed that TRV027 failed to show the hoped for benefits to patients in the BLAST-AHF study,” said David Soergel, Trevena’s chief medical officer, in a statement. “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.”
The company now indicates it plans to make a strategic pivot in supporting its Phase III oliceridine pain program, along with other early stage programs.
Oliceridine (TRV130) is in Phase III trials for moderate to severe pain. The company used its ABLE platform to develop the intravenous drug, which is the first µ-receptor G protein pathway selective modular, or µGPS. In February 2015, the U.S. Food and Drug Administration (FDA) granted the drug Breakthrough Therapy status.
On May 2, the company reported that it had wrapped up its End-of-Phase II Meeting with the FDA and agreed on the key elements of TRV130’s Phase III design.
“We are very pleased with the outcome of our End-of-Phase II discussion with the FDA,” said Maxine Gowen, Trevena’s chief executive officer, in a statement. “We appreciate the valuable guidance the FDA has provided, and look forward to continuing a constructive relationship as we advance our Phase III registration program. We remain focused on bringing oliceridine to market as a new and potentially differentiated analgesic for patients and caregivers seeking alternatives to conventional opioids.”
The two Phase III studies will include APOLLO-1, which will study pain for 48 hours after bunionectomy, and APOLLO-2, which will evaluate pain for 24 hours after abdominoplasty.
Both studies are expected to begin in the second quarter of 2016, with top-line data in the first quarter of 2017. Trevena also hopes to file a New Drug Application (NDA) for oliceridine in the second half of 2017.
Trevena currently believes its available cash and investments will continue to fund operations into 2018. As of March 31, 2016, the company reported $163.5 million in cash, cash equivalents and marketable securities.
The company also has at least two other compounds in its pipeline. TRV734 is an oral drug for moderate to severe pain that is currently in Phase I, and TRV250, which is an oral medication to treat migraine headaches.
The company released its first quarter financials on May 5. Research and development costs for the first quarter were $15.8 million, compared to $10.6 million in the first quarter of 2015, related mostly to increased clinical trial expenses. General and administrative expenses were also up, $3.9 million in this year’s first quarter compared to $3.1 million in 2015’s first quarter.
