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GE Healthcare, Lantheus start second Flurpiridaz phase 3 clinical trial

par Thomas Dworetzky , Contributing Reporter
GE Healthcare and Lantheus have begun a second Phase 3 clinical trial of Flurpiridaz 18F to detect coronary artery disease (CAD).

CAD strikes nearly 15.5 million Americans over 20 years of age, and is the number one cause of death in the U.S. and Europe.

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The study, called AURORA, is looking at the efficacy of Flurpiridaz 18F injection positron-emission tomography (PET) myocardial perfusion imaging (MPI) to spot the disease.

“The second Phase 3 study of Flurpiridaz 18F represents a significant milestone in the development of this promising investigational agent. Importantly, it illustrates our strong collaboration with GE Healthcare, and we look forward to the continued progress of the clinical program,” Lantheus president and CEO Mary Anne Heino said in a statement.

The AURORA study enrolled its first patient in 2018 and will sign up a total of patients for the trial, during which they will be followed to 2020.

“We are thrilled to see this critical stage of the study move forward,” said Kevin O’Neill, general manager of Core Imaging for GE Healthcare.”

In mid-2017 GE Healthcare and Lantheus had agreed to continue phase 3 development and global commercialization of flurpiridaz F 18.

Flurpiridaz F 18 is a fluorine 18-labeled PET agent with a 110-minute half-life that can be used together with treadmill exercise, which is not feasible with other PET tracers, for myocardial perfusion imaging.

The first phase 3 study, which was announced in May 2015, found that flurpiridaz F 18 improved CAD detection and reduced radiation exposure compared to SPECT imaging. Subgroup analyses revealed that flurpiridaz F 18 PET imaging seems to work best in women, obese patients and those with multi-vessel disease.

GE has been much in the news over its moves to reposition itself. In its latest efforts to shed non-core holdings, in July, private equity firm Veritas Capital and GE Healthcare closed their $1 billion deal announced in April.

The move is part of a dramatic time, including the spinning off of GE Healthcare, announced in late June, as the final major deal designed to cut debt, simplify company structure, and raise cash. These have included spinning off its train manufacturing business and the $3.3 billion sale of its distributed power division.

Plans also call for selling off shares of its ownership in oil services company Baker Hughes over the next two to three years.

“We are aggressively driving forward as an aviation, power and renewable energy company – three highly complementary businesses poised for future growth. We will continue to improve our operations and balance sheet as we make GE simpler and stronger,” CEO John Flannery said at the time.

The buy was called “an exciting chapter” by Veritas Capital CEO and managing partner Ramzi Musallam in a statement.

When the deal was announced in April, he had called the opportunities in the $9 billion healthcare tech market “tremendous.”

Beyond the IT assets, the entire GE Healthcare enterprise includes magnetic imaging, medical diagnostics and drug discovery. The healthcare unit pulled in just 16 percent of companywide sales last year, adding up to $19.1 billion.

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