GE Healthcare (NYSE: GE) and Lantheus Holdings, Inc. (NASDAQ: LNTH), parent company of Lantheus Medical Imaging, Inc. have started a second Phase 3 clinical trial of flurpiridaz 18F, an investigational agent being evaluated for the detection of coronary artery disease.
Flurpiridaz18F is designed as a positron emission tomography (PET) myocardial perfusion imaging (MPI) agent. The companies agreed in April 2017 to work together on Phase 3 development and commercialization of flurpiridaz F 18.
In the prospective, open-label AURORA study, patients with suspected coronary artery disease and for whom an intracoronary angiography has been indicated will undergo a single-photon emission computed tomography (SPECT) MPI and a flurpiridaz 18F injection PET MPI before having coronary angiography. Investigators in the international, multicenter study will seek to determine the diagnostic efficacy (sensitivity and specificity) of the flurpiridaz 18F injection PET MPI in detecting significant coronary artery disease.