Diadem Presents Clinical Validation Interim Data Confirming Its AlzoSure® Prognostic Biomarker Test Accurately Predicts Progression to Alzheimer's Disease

• Longitudinal Data from 482 Patients Validates that AlzoSure® Can Predict Progression to AD Early in the Disease Process with >90% Accuracy
• AlzoSure Predict Identifies Patients Who Will Progress to Alzheimer's Up to Six Years in Advance of Other Diagnostic Tests with Simple Blood Draw
• AlzoSure Predict Demonstrates Superior Performance in Predicting Progression to AD than PET Imaging or CSF Biomarkers
• Clinical Validation Interim Data Are Being Presented at 21st BioEquity Europe Conference May 18-19, 2021

MILAN, May 18, 2021 /PRNewswire/ -- Diadem srl, a company developing the first blood-based test for the early prediction of Alzheimer's disease (AD), today announced top-line interim results from a global clinical validation study of its AlzoSure^® Predict prognostic biomarker test, which can accurately predict progression to Alzheimer's disease years before symptoms appear. The interim data are being presented today at the 2021 BioEquity Europe virtual conference. Overall, they confirm the results of a Discovery Cohort analysis presented at the AAIC Satellite Symposium earlier this month. The new data show that AlzoSure Predict identifies those Cognitive Normal and Minor Cognitive Impairment (MCI) patients who will progress to AD-dementia with high accuracy (>90% PPV) and confirm its capability to discriminate different stages of cognitive decline from asymptomatic to mild impairment to full dementia. In this cohort, AlzoSure Predict had very good selectivity for distinguishing between patients progressing to AD dementia and Other Dementia (OD), and It also demonstrated superior predictive performance to PET imaging and cerebral spinal fluid (CSF) biomarkers across all groups.

The Diadem AlzoSure Predict assay uses a proprietary antibody to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. Previous studies suggest that this p53 variant has utility as a predictive biomarker to identify individuals likely to progress to AD up to six or seven years before symptoms appear.

The interim Clinical Validation analysis is based on longitudinal data from 482 patients from major biobanks in Australia, Europe and the US—the first cohort of the more than 1000 patients globally who will ultimately be included. They include individuals over the age of 50 at different stages of cognitive decline: Cognitive Normal, MCI and Demented (either AD or OD). Patients were followed longitudinally for up to 144 months. The data include comparative results from PET imaging, cognitive test performance and CSF biomarker and other blood biomarker assays. Complete data from the Clinical Validation analysis are being submitted for publication in a peer-reviewed journal.

The data are being presented today at BioEquity Europe by Diadem's CEO Paul Kinnon. Mr. Kinnon noted, "Last week at the AAIC Satellite Symposium we presented exciting data from our Discovery cohort study showing that our AlzoSure Predict prognostic biomarker test accurately identifies individuals who will progress to Alzheimer's dementia six or seven years before symptoms appear or are detectable using traditional diagnostic methods."

Mr. Kinnon continued, "These interim data from our larger Clinical Validation study confirm and extend those results. This is good news for the millions of families worldwide who will confront AD in the coming years, since our simple, accessible blood-based assay will allow for therapeutic interventions early in the disease process, when slowing or stopping disease progression is far more feasible. It will also enable more effective clinical trials of investigative therapies for AD. We look forward to sharing the full results from the Clinical Validation study in the coming months."

Diadem is developing the AlzoSure assay as a simple, non-invasive plasma-based biomarker test to accurately predict the probability that a patient with asymptomatic mild cognitive impairment will progress to Alzheimer's dementia. The company's patented technology uses an analytical method that includes a proprietary antibody developed by Diadem designed to bind to the conformational variant U-p53^AZ protein and its target sequences. Diadem is currently conducting further validation studies in about 1000 subjects, with additional results expected this year. The company plans to initiate a global launch in collaboration with strategic partners within the next 12 months.

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.

About Diadem

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/.

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SOURCE Diadem srl