GE Healthcare (NYSE:GE) and Lantheus Holdings (NSDQ:LNTH) today announced positive trial results for an investigational radiotracer.
The Phase III clinical trial for the Flurpiridaz radiotracer met its co-primary endpoints. It exceeded a 60% threshold for both sensitivity and specificity in detecting coronary artery disease (CAD). GE and Lantheus shared the results at the American Society of Nuclear Cardiology (ASNC) Congress, in Florida.
According to a news release, the data also demonstrate higher diagnostic efficacy and image quality for the radiotracer. These data compared Flurpiridaz to single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI).
The trial included over 600 patients across sites in the U.S., Europe and Canada. It assessed the diagnostic efficacy of Flurpiridaz in detecting CAD with invasive coronary angiography as a standard of truth. The companies said that, if approved, the investigational agent would offer broad available distribution and a half-life of almost two hours. That half-life removes the need for it to be manufactured in the immediate vicinity of the imaging department. It could also make it suitable for exercise stress testing, which is not currently feasible with existing cardiac PET radiotracers.
“These results are truly promising for the nuclear cardiology community and CAD patients,” said Dr. Tim Bateman, co-director of the cardiovascular radiologic imaging program at Saint Luke’s Hospital, Missouri. “From ASNC’s inception, its leaders have laid out the specifications for an ideal myocardial perfusion tracer. In my view Flurpiridaz could meet this goal, expanding how PET MPI can be used to image CAD patients moving forward.”
GE Healthcare leads the funding and development of Flurpiridaz. If it is approved, the company will hold global commercialization rights. Lantheus collaborated on the development and will collaborate on potential commercialization through a joint steering committee. It is entitled to royalties based on commercial sales.
“The positive Phase III trial results are a key step towards future approval of Flurpiridaz injection as a potential new cardiac PET agent which could improve the detection of coronary artery disease,” said Dr. Francois Tranquart, global head of clinical development for GE Healthcare Pharmaceutical Diagnostics. This is another example of GE Healthcare investing in our portfolio of molecular imaging products to help improve diagnostic accuracy and patient outcomes.”