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.
The first patient was enrolled in the study in June 2018. A total of 650 patients will be enrolled, with the last patient follow-up projected to occur in August 2020.
Coronary artery disease affects an estimated 15.5 million Americans 20 years of age or older, according to the American Heart Association and is the leading cause of death in the United States, notes the National Heart, Lung, and Blood Institute. In Europe, coronary artery disease is responsible for 20% of deaths among women and 19% of all deaths among men each year, according to the European Heart Network.
“The second Phase 3 study of Flurpiridaz 18F represents a significant milestone in the development of this promising investigational agent,” said Mary Anne Heino, president and CEO of Lantheus in a prepared statement. “Importantly, it illustrates our strong collaboration with GE Healthcare, and we look forward to the continued progress of the clinical program.”
Kevin O’Neill, General Manager of Core Imaging for GE Healthcare, said, “We are thrilled to see this critical stage of the study move forward. We are committed to the development of a potential new diagnostic option for clinicians and their CAD patients in the future.”
Under the 2017 agreement, GE Healthcare will lead and fund the development of flurpiridaz 18F, including the second Phase 3 clinical study. GE Healthcare will also have exclusive worldwide rights for the commercialization of Flurpiridaz18F. Lantheus was to receive $5 million up front as part of the deal, with an opportunity for up to $60 million in regulatory and milestone payments, as well as royalties inside and outside the US. Lantheus also agreed to collaborate in both the development and commercialization process and maintains the option to co-promote the agent in the United States.