GE Healthcare has launched a second Phase III clinical trial (AURORA) for the use of Flurpiridaz 18F Injection in positron-emission tomography (PET) myocardial perfusion imaging (MPI) to detect coronary artery disease (CAD).
The prospective, international, multi-centre, open-label trial is being conducted in alliance with Lantheus Holdings, the parent company of diagnostic agents maker Lantheus Medical Imaging.
During the trial, single-photon emission computed tomography (SPECT) MPI and Flurpiridaz 18F Injection PET MPI will be performed in 650 subjects with suspected CAD.
The trial will recruit patients who are indicated for an intracoronary angiography (ICA), and both the MPI will be carried out before the coronary angiography procedure.
The primary endpoint of the trial is diagnostic efficacy, comprising both sensitivity and specificity, of the Flurpiridaz 18F Injection PET MPI in detecting significant CAD.
While the patient enrolment commenced in June this year, the last follow-up is expected to take place in August 2020.
Lantheus president and CEO Mary Anne Heino said: “The second Phase III 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 programme.”
GE Healthcare signed a definitive licence agreement with Lantheus Holdings last year for the continued Phase III development and commercialisation of Flurpiridaz18F.
Under the agreement, GE Healthcare will lead and fund the development, as well as hold the exclusive worldwide commercialisation rights.
Lantheus will partner in both the development and commercialisation process under a joint steering committee and also has the option to co-promote Flurpiridaz18F in the US.