Biomarkers: a Beacon of Hope for the Future of Alzheimer's
Last week, the 2022 International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD) showcased the latest research from the brightest scientists on the subjects. There was a variety of research, but one theme stood out: the promising nature of using biomarkers to diagnose and create personalized treatment plans for Alzheimer’s patients.
Tokyo-based Eisai and Massachusetts-based Biogen presented their findings on biomarker results with lecanemab, an investigational humanized monoclonal antibody to treat Alzheimer’s. Eisai developed the drug with research from BioArctic, and Biogen is helping develop and commercialize it. Lecanemab received a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) in June 2021 and a Fast Track designation in December 2021.
As Eisai has been testing lecanemab, it has been careful to include biomarker research. Lecanemab works by reducing amyloid plaque in the brain, but it also has the effect of reducing Aβ42/40 and P-Tau181, two plasma biomarkers that signal Alzheimer’s progression.
In Study 201, an 18-month study, Eisai explored biomarker effects of stopping and restarting lecanemab treatments in patients across five years of disease trajectory. The study showed that Aβ42/40 and P-Tau181 levels correlate with changes on the Clinical Dementia Rating scale, indicating that biomarkers could be a concrete, fast way to measure clinical changes in Alzheimer’s patients, rather than brain scans.
Another company investing in Alzheimer’s biomarker research is Diadem. At the 2022 AD/PD conference, Diadem presented data demonstrating its new AlzoSure® Confirm blood test. The blood test is designed to accurately identify patients with Alzheimer’s disease.
It works by testing for U-p53AZ, an integrative biomarker that has been associated with Alzheimer’s disease in more than 400 studies. The biomarker interacts with amyloid plaque and tau, which are factors linked to the worsening of Alzheimer’s symptoms.
By using a longitudinal database of about 500 patients, Diadem tested the full sequence of the U-p53AZ biomarker. Researchers found that post-translational modifications of U-p53AZ left chemical signature “fingerprints” which were characteristic of different stages of Alzheimer’s disease. The link between the fingerprints and the stages of Alzheimer’s is so accurate that Diadem is hoping to use this biomarker blood test as a way to reliably diagnose patients with Alzheimer’s disease instead of other forms of dementia.
“The lack of timely, accurate and affordable diagnostics has hindered progress in developing more effective treatment options for AD patients, and we look forward to working with a variety of partners to produce and report more confirmatory data on AlzoSure® Confirm," said Paul Kinnon, CEO of Diadem.
Another major use of biomarker research at the conference came from ProMIS Neurosciences. ProMIS is a biotech company focused on developing therapeutics for misfolded proteins, such as amyloid plaque and oligomers, both of which contribute to Alzheimer’s disease.
ProMIS has been developing a potential Alzheimer’s vaccine. The vaccine works by triggering the body to produce antibodies that target toxic Abeta oligomers, without triggering dangerous immune responses that normally come from Abeta. The vaccine is based on ProMIS’ research that uses a novel biomarker approach that helps slow neuron deaths in patients with Alzheimer’s.
“Based on the advent of reliable blood-based biomarkers for AD [Alzheimer’s disease] detection, the need for preventive treatment will grow. Therapeutic vaccines can be used for this purpose,” read a company statement.