PRESS RELEASE

Life Molecular Imaging Announces Collaboration to Provide Both its Amyloid and Tau PET Imaging Agents for Research of Alzheimer’s Disease in a Large Consortium Clinical Trial Sponsored by National Institute on Aging

 

Use of Neuraceq® Amyloid PET and investigational PI-2620 Tau PET imaging will enhance knowledge about Alzheimer’s disease

 

Boston, August, 1, 2024 – Life Molecular Imaging (LMI) and The University of Wisconsin Alzheimer’s Disease Research Center (ADRC) have entered a collaborative agreement to support the National Institute on Aging (NIA)-sponsored study titled “Consortium for Clarity in ADRD Research Through Imaging (CLARiTI)”. This collaboration provides access for CLARiTI investigators, spanning all 37 ADRCs in the United States, for both F18 Florbetaben (Neuraceq®) Amyloid PET and [18F] PI-2620 Tau PET. Neuraceq® is a commercially available Positron Emission Tomography (PET) imaging agent indicated for the estimation of β-amyloid neuritic plaque density in patients with cognitive impairment being evaluated for Alzheimer’s disease (AD) or other causes of cognitive decline. PI-2620 is an investigational, next generation F18-labeled PET imaging agent that targets tau proteins in the brain. PI-2620 is currently in phase 3 clinical development for the detection of tau in AD and will be used within CLARiTI to characterize AD and related dementias. Tau pathology is hallmark in a variety of neurodegenerative disorders, including AD, progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), frontotemporal lobar dementia (FTLD), and others. The CLARiTI study will recruit 2,000 subjects over a period of 5 years.

“This study is designed to shed light on the complex interplay of multiple pathologies contributing to dementia, ultimately advancing our understanding and treatment of this devastating condition,” said Sterling Johnson, PhD, Professor of Medicine, University of Wisconsin School of Medicine and Public Health and the CLARiTI study lead. “We are thrilled to also partner with LMI to use Neuraceq® for Amyloid PET and PI-2620 for Tau PET imaging in this important study.”

“We are excited to partner with The University of Wisconsin and the greater ADRC network to support the CLARiTI study” said Andrew Stephens, Chief Medical Officer, LMI. “At LMI, our mission is to provide innovative PET tracers to reduce the burden of disease, and the CLARiTI study objectives align closely with this mission. We have entered a new era of Alzheimer’s research, and CLARiTI will help illuminate new avenues of understanding for this complex disease.”

About Neuraceq (florbetaben 18F)

Indication
Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq® scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq® scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq® is an adjunct to other diagnostic evaluations.

Limitations of Use

  • A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder.
  • Safety and effectiveness of Neuraceq® have not been established for:
    • Predicting development of dementia or other neurologic conditions
    • Monitoring responses to therapies.

Important Safety Information

Risk for Image Interpretation and Other Errors
Errors may occur in the Neuraceq® estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq® images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq® scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq® scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.

Radiation Risk
Neuraceq®, similar to other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

Common Adverse Reactions
The overall safety profile of Neuraceq® is based on data from 1,090 administrations of Neuraceq® to 872 subjects. No serious adverse reactions related to Neuraceq® administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq® were injection site reactions consisting of erythema (1.7%), irritation (1.1%) and pain (3.4%).

For more information please visit: neuraceq.com

About PI-2620
[18F] PI-2620 is an investigational PET imaging agent that was discovered and developed as part of a research collaboration between AC Immune and LMI. LMI has the exclusive, worldwide license for research, development and commercialization of Tau PET tracers generated within the discovery program. [18F] The absence of significant off-target binding enables [18F] PI-2620 to detect and quantify early tau deposition in the brain.

[18F] PI-2620 is currently under investigation in several clinical studies as a targeted radiopharmaceutical for the detection of tau deposits in the human brain including a Phase 3 image-to-autopsy study. [18F] PI-2620 also shows promise for detection of tau in non-AD tauopathies like progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS).

About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI) is an international pharma company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit https://life-mi.com.

About Life Healthcare Group
Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years’ experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: https://www.lifehealthcare.co.za/ | https://life-mi.com/

For media queries
Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging
Tel: +1.484.735.2840 |  b.hahn@life-mi.com

Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS

  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).

DRUG INTERACTIONS

  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.

SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

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