Presentation at Clinical Trials on Alzheimer’s Disease Meeting Highlights How Diadem’s AlzoSure® Predict Can Enable AD Clinical Trials and Screening for Early Detection of AD
—Longitudinal Analyses Show AlzoSure® Predict Identifies Individuals Who Will Progress to Alzheimer’s Disease with High Accuracy Up to Six Years Before Diagnosis—
—As an Accurate Prognostic Test, AlzoSure® Predict Can Stratify Patients for AD Clinical Trials, Potentially Enabling More Rapid and Efficient Approvals by Making It Possible for Drug Developers to Select and Monitor the Patients Most Likely to Benefit—
—AlzoSure® Predict Requires Only a Simple Blood Draw and a 24-Hour Lab Analysis ─ Diadem Is Partnering with Clinical Labs to Ensure Wide Access after the Expected 2022 Launch—
Based on the positive data results from the longitudinal studies completed to date, Diadem CEO Paul Kinnon concluded that AlzoSure® Predict could enable the widespread prognostic screening that is a prerequisite for the early interventions needed to slow or stop Alzheimer’s disease progression, noting that AlzoSure® Predict is a simple, blood-based biomarker test that is expected to be widely available through clinical laboratories at an accessible cost.
Kinnon also pointed to the important role that AlzoSure® Predict can play in facilitating and accelerating clinical trials for new therapeutic candidates to treat AD, by enabling drug developers to easily identify patients who will progress to AD early in the disease process, when potential new therapies have the best chance of slowing or stopping the disease progression that results in serious cognitive impairment.
Kinnon’s presentation in the November 11th Focus on Biomarkers in AD session included data from multiple studies confirming the ability of the AlzoSure prognostic test to discriminate with high accuracy between individuals who will remain cognitively normal, those who will decline to cognitive impairment and ultimately AD, and those affected by non-Alzheimer’s cognitive disorders. The Diadem assay uses a proprietary antibody to measure blood levels of a conformational variant of the p53 protein (U-p53AZ), which has been implicated in the pathogenesis of AD in more than 400 published scientific studies.
Kinnon presented conclusions from the first phase of Diadem’s Clinical Validation Study that includes data on 482 patients followed for up to 12 years. Patients were aged 50 years or older and asymptomatic or at the prodromal stages of AD or other dementias at the start of the study. Available data used in the comparative analyses included PET imaging studies, cognitive test performance, and cerebral spinal fluid and blood biomarker scores. Results of the first phase Clinical Validation Study were published in an August MedRxiv preprint. The second phase of the Clinical Validation Study includes biobank data on more than 1,000 patients in the US and Europe and is due for completion around the end of this year.
Kinnon noted, “Interest in improving the diagnosis and treatment of AD has never been greater, as the enormous individual and societal costs of this devastating disease have been brought to the fore by the pandemic. We believe AlzoSure® Predict can play a valuable role in identifying individuals who will progress to AD years before symptoms are established, allowing interventions at an early stage when they are most likely to be helpful. Importantly, the prognostic accuracy of AlzoSure® Predict can facilitate clinical trials for new AD therapies, helping drug developers identify and monitor early-stage patients who will progress to AD if nothing is done, and at a stage when drug candidates may have the best chance of modifying the progression of the disease.”
The first phase of the AlzoSure® Predict Clinical Validation Study concluded that AlzoSure® Predict:
- Is able to predict cognitive decline to AD dementia with an AUC (a measure of accuracy) of greater than 90%, regardless of the cognitive status of patients at the time of the test.
- Can determine the classification of the patient’s stage of dementia (cognitively normal or mild cognitive impairment) in a single test, with an AUC of greater than 95%.
- Showed superiority compared to “gold standard” Pib-PET imaging in identifying which patients with milder cognitive deficits would decline to AD dementia.
- Achieved superior prognostic performance compared to amyloid biomarkers.
- Achieved superior performance to CSF methods for detecting early AD.
- Achieved good specificity in differentiating individuals progressing to Alzheimer's disease from those experiencing other types of dementia.
- Has an 84% concordance with amyloid levels in all individuals tested.
The Diadem CTAD presentation will be available on the Diadem website beginning November 15.
About Alzheimer’s Disease
There are about 50 million people suffering from dementia worldwide. Alzheimer’s disease is the most common form and accounts for 60-70% of cases. At present there are no disease modifying treatments for Alzheimer's, and therapies to treat symptoms are limited. There are about 10 million new cases per year, and the incidence is rising rapidly as the population ages. The current total cost of care is enormous--estimated at $1 trillion in the U.S. annually and expected to double by 2030. Currently, diagnosis of Alzheimer’s disease is slow, inconclusive, invasive and expensive. Development of effective therapies for Alzheimer’s has been hindered by the lack of accurate and cost-effective prognostic and diagnostic methods.
Diadem was founded as a spin-off of the University of Brescia (Italy). The company is developing the first blood-based prognostic test for the early detection of dementia, with a focus on Alzheimer’s disease. The lack of accurate, accessible and affordable diagnostic tools is a major contributor to the absence of effective treatments for this devastating condition. As a result, patients are not diagnosed until late in the illness, when effective treatment is no longer possible. Diadem’s rapid, accurate and cost-effective blood-based prognostic test makes it possible for the first time to identify patients early in the disease process, when effective interventions and better outcomes are far more feasible. The utility of the approach has been demonstrated in early clinical studies. Additional retrospective and prospective clinical trials are ongoing and planned to further validate clinical claims and support widespread adoption and use. Diadem’s founding lead investor is Milan-based Panakes Partners, a venture capital firm that finances promising high potential biomedical companies in Europe and Israel. Diadem is preparing for rapid commercialization of its initial Alzheimer’s prognostic via a global launch in collaboration with strategic partners. For more information, visit www.diademdx.com/.