Diadem presented its clinical Data and commercialisation plans for its AlzoSure prognostic biomarker test, a blood-based test for the early prediction of Alzheimer’s disease (AD), at the 2020 Alzheimer’s Disease International Conference (ADI), December 2020. The company, reported these results at a symposium it hosted on its prognostic biomarker test at ADI.
According to Diadem’s press release, AlzoSure Predict is a simple, non-invasive plasma-based biomarker test that has been validated in early studies to accurately predict the probability a patient with asymptomatic mild cognitive impairment (MCI) will progress to dementia due to AD. The company’s patented technology measures a conformational variant of p-53 (U-p53), which is over-expressed in Alzheimer’s patients, using an analytical method that includes a proprietary antibody and target sequences developed by Diadem. Further clinical studies are currently underway and the company plans a global launch in collaboration with strategic partners in 2021.
Diadem CEO Paul Kinnon and Simona Piccirella, Vice President of Product Development & Operations, presented an overview of promising initial clinical data showing the potential utility of AlzoSure Predict for identifying which patients will progress from asymptomatic MCI to AD. They also discussed the company’s clinical, regulatory and commercialisation plans.
Symposium panelists included Diadem Medical Advisory Board AD experts Tamas Bartfai, Jeffrey Cummings and Anne Fagan. In an interactive session, they discussed the scientific background of the AlzoSure Predict biomarker test, its performance to date, and initial clinical validation data. They also explored how AlzoSure tests could fit into and impact the patient clinical pathway, along with their suitability and potential to improve patient treatment and long-term outcomes.
As part of the Symposium, Diadem presented early clinical validation data comparing AlzoSure Predict’s prognostic performance with historical diagnostic results. AlzoSure accurately predicted which individuals would experience cognitive decline to Alzheimer’s dementia, achieving Positive and Negative Predictive Values (AUC’s) of greater than 90%, regardless of cognitive status (cognitively normal or MCI) at the time of the test. AlzoSure showed superior ability to predict cognitive decline to Alzheimer’s dementia compared to “gold standard” PiB-PET imaging, and AlzoSure predicted progression to Alzheimer’s dementia significantly better than amyloid and tau-based assays combined, using the same baseline characteristics.
Fagan commented, “The beauty of the biomarker test is that it is available. It is a simple blood test and people are used to that. It can be administered in the physician’s office and serve as the basis for discussions with family members and caregivers. I think it’s a very attractive option.”
Cummings said, “We are in the age of biomarkers right now that will hopefully lead us to the age of therapies.” Cummings concluded, “This is the kind of biomarker test companies are looking for.”
According to the press release, further validation studies of AlzoSure Predict involving about 1,000 individuals are expected to be completed during the first half of 2021.
Kinnon said, “We were pleased at the opportunity to share the encouraging early clinical data and our commercialization plans for our AlzoSure Predict prognostic assay.” He continued, “Based on these results, we believe that our ongoing studies will confirm its ability to forecast which patients will go on to develop symptomatic AD up to six years before symptoms appear, well before any current diagnostic is accurate. We see AlzoSure as a game-changer in Alzheimer’s disease – enabling earlier treatment for patients and the development of more effective AD therapies for administration before brain damage and loss of cognitive function are irreversible.”