Diadem Reports New Data Showing Its AlzoSure® Predict Blood Test Can Accurately Identify “Rapid Progressors” Who Will Develop Alzheimer’s Disease Within Two Years

—New Computational Approach with PPV >95% Represents Another Significant Feature of AlzoSure® Predict Blood Test that Can Accurately Predict Whether Individuals Will Progress to Alzheimer’s Disease (AD) Up to Six Years Before Diagnosis—

—Identifying Rapid Progressors Who Will Develop AD Within 2 Years Will Be Especially Valuable with the Growing Availability of Drugs for Early AD, Enabling Access to Potentially Disease-Modifying Treatment and Facilitating New Drug Research—

Milan, Italy and San Francisco, California, January 9, 2023 – Diadem SpA, a company developing the first blood-based test for the early prediction of progression to Alzheimer’s disease (AD), today announced that its researchers have developed computational methods that enable its AlzoSure® Predict prognostic technology to accurately identify individuals who will rapidly progress to AD within two years’ time. More than 95% of the patients above the new computational “cutoff” used to define “rapid progressors” were shown to progress to AD within two years’ time, regardless of their baseline diagnosis. Using a modified form of the new approach, Diadem was able to do even better, accurately identifying a cohort where 100% of the patients progressed to AD within two years, while none of the patients not included in the modified cutoffcohort did so.

The computational analysis were developed using a relatively limited number of patient samples from major international longitudinal patient databases. The results will be further validated and expanded, and these analyses are already underway using global cohorts of qualified biological samples.

Diadem CEO Paul Kinnon noted, “We believe that this new refinement of our AlzoSure® Predict test could not be more timely, as last week’s FDA approval of lecanemab, which shows promising signs of slowing cognitive decline in early AD, highlights the need for accurate and economical screening tools to select patients most likely to benefit from early treatment. The cost benefit trade-off in choosing whether or not to take these drugs, with their potential side effects and high costs, is shifted when a patient is identified by AlzoSure® Predict’s new computational cutoff as having a high probability of advancing to AD in just two years’ time. The additional feature should also be valuable for drug development, since it will allow researchers to select “rapid progressor” patients for clinical testing who are almost certain to develop AD within two years, enabling a much faster and more cost-effective read-out of clinical trial results.”

Diadem is currently expanding its initial confirmatory studies of the new computational cutoff. It plans to present data on its results at scientific meetings later this year. The company is also planning for the commercial launch of AlzoSure® Predict in the U.S. this year, in collaboration with a major diagnostics partner.

AlzoSure® Predict can allow drug developers to screen, enrich and stratify patient populations to facilitate Alzheimer’s disease clinical trials. Use of the test enables researchers to identify with high confidence individuals who will experience a decline to Alzheimer’s dementia years in advance of diagnosis .

Clinical studies show that AlzoSure® Predict is able to predict cognitive decline to AD dementia with an AUCgreater than 90%, regardless of the cognitive, amyloid or tau status of the patient at the time of testing.AlzoSure also has demonstrated superiority compared to Pib-PET amyloid imaging in predicting decline to AD dementia in patients before, or with, early signs of cognitive deficits. The company is in the final stages of further validating its earlier findings using longitudinal data from the U.S.-based Alzheimer’s Disease Research Centers (ADRC) and Alzheimer’s Disease Neuroimaging Initiative (ADNI) cohorts.

AlzoSure® Predict is a non-invasive biomarker blood test that can identify with high accuracy whether individuals over the age of 50 with signs of cognitive impairment will or will not progress to Alzheimer’s disease up to six years before diagnosis. AlzoSure® Predict uses a proprietary antibody (U-p53AZ) 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 diagnostic and as a predictive biomarker to identify individuals likely to progress to AD up to six years before symptoms appear.

The utility of AlzoSure® Predict is supported by clinical data from a large longitudinal study that was the basis for AlzoSure® Predict’s Breakthrough Device designation from the U.S. Food & Drug Administration and its CE-IVD marking in the E.U. AlzoSure® Predict requires only 1mL of blood and 4 to 5 days for analysis to detect AD at the asymptomatic and prodromal (early symptomatic) stage, with an accuracy greater than 95% up to at least 6 years in advance of the clinical onset of symptoms. Previous research also demonstrated that AlzoSure® Predict can discriminate between the different kinds of dementia with high accuracy.

About Diadem

Diadem was founded as a spin-out 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 longitudinal clinical studies that were the basis for awarding CE-IVD marking in the E.U. and a Breakthrough Device designation in the U.S. Additional retrospective and prospective clinical trials are ongoing to further validate clinical claims and support widespread adoption and use. Diadem is preparing for commercialisation of AlzoSure® Predict in collaboration with global strategic partners. The company is also developing AlzoSure® Confirm, a blood-based diagnostic test for AD that has shown promising results in early studies. For more information, visit diademdx.com/.