PRESS RELEASE

Life Molecular Imaging Announces Start of the Phase 3 Histopathology Study “ADvance” for the Tau PET Tracer [18F]PI-2620

Advancing the understanding of tau pathology in AD using PET

BERLIN, Germany, January 17, 2023 – Life Molecular Imaging (LMI) announces today that the first patient has been imaged with [18F]PI-2620 in the ADvance Phase 3 clinical study. This study is an open-label, multi-center, non-randomized pivotal Phase 3 study to assess the efficacy and safety of PET imaging with [18F]PI-2620 for detection of tau deposition in subjects with Alzheimer’s disease (AD) during lifetime when compared to histopathology obtained after death and completion of brain autopsy.

The ADvance study will be performed exclusively in the US and will enroll approximately 200 end-of-life subjects. The primary objective is to determine the sensitivity and specificity of the visual assessment of [18F]PI-2620 PET imaging compared to postmortem histopathological verification of tau neurofibrillary pathology associated with AD as the standard of truth.

[18F]PI-2620 is a potentially best-in-class tau PET tracer with high binding affinity and selectivity for aggregated tau. Tau aggregates are an important indicator of neuronal death and correlate strongly with cognitive decline in AD. Accurate detection of aggregated tau may therefore contribute to improved diagnosis and advanced monitoring of cognitive performance in patients with dementia.

“A validated tau PET tracer will lead to an improved understanding of the pathophysiology of tauopathies and may aid in establishing an earlier and more accurate clinical diagnosis of neurodegenerative diseases”, said Dr. Ludger Dinkelborg, CEO of Life Molecular Imaging. “We are proud to announce the start of this Phase 3 study, which marks another milestone on our vision to reduce the burden of disease by improving early diagnosis and characterization of chronic and life-threatening diseases. This unique tau imaging biomarker is an important addition to Neuraceq®, our approved and globally available beta-amyloid targeting product, thereby complementing our neurodegeneration portfolio”.

Dr. Andrew Stephens, M.D., Ph.D., Chief Medical Officer at Life Molecular Imaging added: “We are highly encouraged by the clinical data obtained to date with our tau PET tracer [18F]PI-2620. We are very much looking forward to continuing the development of [18F]PI-2620 as the potentially best-in-class tau PET tracer in patients with AD by starting this Phase 3 study.”

The availability of a reliable and validated diagnostic agent to visualize disease development in patients with AD is critical for the successful development of novel therapies targeting amyloid and tau deposition. [18F]PI-2620 has the potential to become a diagnostic agent that can identify tau in AD and other tauopathies at an early stage and will help to advance the understanding of the pathophysiology of neurodegenerative diseases.

Further details of the ADvance Phase 3 study design are available on clinicaltrials.gov (NCT05641688).

About [18F]PI-2620
[18F]PI-2620 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. It has demonstrated robust brain uptake and fast wash-out in non-target regions, a broad imaging window between 30 and 90 minutes post-injection for AD, and excellent reproducibility between test and retest scans. 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. [18F]PI-2620 also shows promise for non-AD tauopathies like progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS).

About Neuraceq® (florbetaben 18F)

Indication
Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta 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 amyloid 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 (i) predicting development of dementia or other neurologic conditions and (ii) monitoring responses to therapies.

Important Safety Information

Risk for Image Interpretation and Other Errors
Neuraceq® can be used to estimate the density of beta-amyloid neuritic plaque deposition in the brain. Neuraceq® is an adjunct to other diagnostic evaluations. Neuraceq® images should be interpreted independent of a patient’s clinical information. Physicians should receive training prior to interpretation of Neuraceq® images. Following training, image reading errors (especially false positives) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy.

Radiation Risk
Administration of Neuraceq®, like 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. It is important to ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

Most Common Adverse Reactions
In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 1090 Neuraceq® administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%).

For full prescribing information visit https://neuraceq.com/wp-content/uploads/2022/09/PRESCRIBING-INFORMATION.pdf

About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI, formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Alliance Medical Group (a member of the Life Healthcare Group) offering an integrated business including research and development laboratories, a network of cyclotrons, radiopharmacies and imaging facilities. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine. The organization strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. 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 38 years’ experience in the South African private healthcare sector, and currently operates 66 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, and wellness, occupational health, primary health and emergency medical services. The Group owns Alliance Medical Group, the leading independent provider of medical imaging services (MRI, CT and PET scans) within Europe, operating internationally across 10 countries. Life Molecular Imaging, a division of Alliance is an integrated pharmaceutical business that includes research and development laboratories, access to a network of cyclotrons and radio-pharmacies and imaging facilities, with Life Radiopharma being Alliance’s distributor of radiopharmaceuticals to diagnose many types of diseases. Visit https://www.lifehealthcare.co.za/

For media queries contact:

Andre Mueller
Clinical & Preclinical R&D Life Molecular Imaging
ADvance@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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