Pipeline

Flurpiridaz F 18

A Novel PET Cardiac Imaging Agent

fluripiridaz pipelineFlurpiridaz F 18 is our most advanced agent in development, with the first of two Phase 3 trials complete. Flurpiridaz F 18 is an investigational positron emission tomography (PET) myocardial perfusion imaging (MPI) agent that may help better evaluate coronary artery disease (CAD), the most common form of heart disease, which affects an estimated 15.5 million Americans 20 years of age or older.

This agent could be particularly useful in difficult to image heart patients, including women and obese patients.

A fluorine 18-labeled agent that binds to mitochondrial complex 1 (MC-1), flurpiridaz F 181 is designed for use in PET MPI to assess blood flow to the muscle of the heart. Based on clinical studies to date, we believe that in comparison to single photon emission computed tomography (SPECT) MPI, the current standard of care, PET MPI with flurpiridaz F 18 potentially provides:

  • Higher image quality
  • Increased diagnostic certainty
  • More accurate risk stratification
  • Reduced patient radiation exposure

The flurpiridaz F 18 Phase 2 study results were published in the Journal of the American College of Cardiology (JACC) on January 29, 20132.

In May 2015, we announced the complete results from the first Phase 3 trial (study 301).

Based on these results, we have redesigned the protocol for our second Phase 3 trial with different primary endpoints. On March 13, 2015, the FDA granted us a Special Protocol Assessment (SPA) in connection with the new (study 303) trial.

Next steps for this promising diagnostic imaging agent

On April 25, 2017, Lantheus entered into a definitive agreement with GE Healthcare for the continued Phase 3 development and worldwide commercialization of flurpiridaz F 18. Under the definitive agreement, GE Healthcare will complete the development program of flurpiridaz F 18, including the second Phase 3 clinical study, pursue worldwide regulatory approvals and, if successful, lead a worldwide launch and commercialization of the agent, with LMI collaborating on both development and commercialization through a joint steering committee.

 

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Sources

  1. Yalamanchili, P, Wexler, E, Hayes, M, Yu, M, MD, Bozek J, Radeke, H, Azure, M, Purohit, A, Casebier, DS, and Robinson, SP. Mechanism of uptake and retention of 18F BMS-747158-02 in cardiomyocytes: A novel PET myocardial imaging agent. Journal Nuclear Cardiology 2007 Nov-Dec;14(6):782-8.
  2. Berman, D.S., Maddahi,J., et al. Phase II Safety and Clinical Comparison with Single-Photon Emission Computed Tomography Myocardial Perfusion Imaging for Detection of Coronary Artery Disease: Flurpiridaz F 18 Positron Emission Tomography. J AM Coll Cardiol. 2013 Jan; 61(4):469-77.