GE Healthcare and Lantheus Phase III Clinical Trial Finds [18F]flurpiridaz PET Radiotracer Could Improve Detection of Coronary Artery Disease

• Phase III medical trial of [18F]flurpiridaz PET diagnostic radiopharmaceutical meets co-primary endpoints for detecting Coronary Artery Disease (CAD)
• Trial additionally met its first key secondary endpoint, demonstrating increased diagnostic efficacy for [18F]flurpiridaz PET in comparison with SPECT Myocardial Perfusion Imaging (MPI)
• With a half-life roughly 12 occasions longer than presently accepted cardiac PET radiotracers, if accepted, [18F]flurpiridaz has the potential to broaden affected person entry to PET MPI
• This radiotracer is a component of GE Healthcare’s pipeline of Molecular Imaging diagnostics aiming to extend diagnostic accuracy and enhance affected person outcomes throughout key care areas

GE Healthcare and Lantheus Holdings Inc (NASDAQ: LNTH) have introduced that the latest Phase III medical trial of their investigational radiotracer, [¹⁸F]flurpiridaz, has met its co-primary endpoints of exceeding a 60 p.c threshold for each sensitivity and specificity for detecting Coronary Artery Disease (CAD). The findings, shared on the American Society of Nuclear Cardiology (ASNC) Congress, in Florida, U.S., additionally reveal [¹⁸F]flurpiridaz Positron Emission Tomography (PET) has increased diagnostic efficacy and picture high quality in sufferers with suspected CAD, in contrast with Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI), the predominant process utilized in nuclear cardiology right now. SPECT MPI represents roughly 6 million procedures per yr within the U.Sⁱ.

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The Phase III Open-Label Study, which concerned over 600 sufferers throughout websites within the U.S., Europe and Canada assessed the diagnostic efficacy of [¹⁸F]flurpiridaz in detecting CAD, the commonest type of coronary heart illnessⁱⁱ and the main trigger of demise globallyⁱⁱⁱ, with invasive coronary angiography as an ordinary of fact. More than 120 million individuals are affected by CAD globally every year^iv and within the U.S. alone, roughly 20 million adults have CAD, with practically 383,000 deaths recorded in 2020^v.

If accepted, this investigational agent would supply the benefits of ¹⁸F, with broad accessible distribution and a half-life of virtually two hours, eradicating the necessity for it to be manufactured within the quick neighborhood of the imaging division. This longer half-life may additionally make Flurpiridaz (¹⁸F) Injection appropriate for train stress testing, which isn’t possible with present cardiac PET radiotracers.

Dr. Tim Bateman, MD, FACC, co-director of the Cardiovascular Radiologic Imaging Program at Saint Luke’s Hospital, Missouri, US, shared: “These results are truly promising for the nuclear cardiology community and CAD patients. From ASNC’s inception, its leaders have laid out the specifications for an ideal myocardial perfusion tracer. In my view [¹⁸F]flurpiridaz could meet this goal, expanding how PET MPI can be used to image CAD patients moving forward.”

Dr. Francois Tranquart, MD, PhD, Global Head of Clinical Development for GE Healthcare Pharmaceutical Diagnostics, Research and Development, stated: “The positive Phase III trial results are a key step towards future approval of Flurpiridaz (¹⁸F) Injection as a potential new cardiac PET agent which could improve the detection of coronary artery disease. This is another example of GE Healthcare investing in our portfolio of Molecular Imaging products to help improve diagnostic accuracy and patient outcomes.”

GE Healthcare has led the funding and improvement of [¹⁸F]flurpiridaz, and, if the imaging agent is accepted, can have world commercialization rights. Lantheus has collaborated on the event and may even collaborate on potential commercialization by way of a joint steering committee. Lantheus is entitled to royalties primarily based on business gross sales.

GE Healthcare’s Pharmaceutical Diagnostics unit is a world chief in imaging brokers used to assist round 100 million procedures per yr globally, equal to 3 sufferers each second. Its Molecular Imaging portfolio combines an revolutionary pipeline with established proprietary merchandise throughout cardiology, neurology and oncology.

About GE Healthcare:

GE Healthcare is the $17.7 billion healthcare business of GE (NYSE: GE). As a number one world medical expertise, pharmaceutical diagnostics and digital options innovator, GE Healthcare allows clinicians to make quicker, extra knowledgeable selections by way of clever gadgets, knowledge analytics, functions and providers, supported by its Edison intelligence platform. With over 100 years of healthcare trade expertise and round 48,000 workers globally, the corporate operates on the heart of an ecosystem working towards precision well being, digitizing healthcare, serving to drive productiveness and enhance outcomes for sufferers, suppliers, well being techniques and researchers all over the world.

Follow us on Facebook, LinkedIn, Twitter, and Insights for the newest information, or go to our web site www.gehealthcare.com for extra info.

About Lantheus

With greater than 60 years of expertise in delivering life-changing science, Lantheus is dedicated to enhancing affected person outcomes by way of diagnostics, radiotherapeutics and synthetic intelligence options that allow clinicians to Find, Fight and Follow illness. Lantheus is headquartered in Massachusetts and has workplaces in New Jersey, Canada and Sweden. For extra info, go to www.lantheus.com.

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ⁱ Data on File: AMR Market Guide 2021.

ⁱⁱWHO Factsheet 2020. Cardiovascular illnesses (CVDs). 11 June 2021.

ⁱⁱⁱGlobal Epidemiology of Ischemic Heart Disease: Results from the Global Burden of Disease Study. July 23 2020.

^ivGlobal Epidemiology of Ischemic Heart Disease: Results from the Global Burden of Disease Study. July 23 2020.

^v Centers for Disease Control and Prevention. Heart Disease Facts. Accessed July 15 2022.

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