ALZpath Announces New Funding from the Alzheimer's Drug Discovery Foundation (ADDF) to Advance a Novel, Diagnostic Blood-Based Assay

Funding will accelerate the analytical and clinical validation of ALZpathDx, a proprietary assay for quantifying phosphorylated tau 217 (pTau217), a highly accurate diagnostic biomarker for Alzheimer's disease.

CARLSBAD, Calif., July 18, 2023 /PRNewswire/ -- ALZpath, a leading developer of innovative diagnostic solutions for Alzheimer's disease, is proud to announce that they have received funding from the Alzheimer's Drug Discovery Foundation (ADDF)'s Diagnostics Accelerator to accelerate the clinical availability of ALZpathDx as a laboratory developed test (LDT). ALZpathDx is a novel, proprietary assay for blood-based measurement of phosphorylated tau at threonine 217 (pTau217), a highly accurate, diagnostic biomarker for Alzheimer's disease. The assay is performed on the Quanterix Simoa HD-X immunoassay analyzer.

The investment comes at a pivotal time in the advancement of Alzheimer's disease treatments, with Biogen and Eisai's Lecanemab (LEQEMBI®) recently receiving traditional FDA approval, ushering in a new era for the next generation of Alzheimer's treatments. A critical barrier to widespread availability and use of these and other treatments to follow is the difficulty in diagnosing Alzheimer's patients, particularly in the early stages of disease onset, when such treatments may have the most profound impact.

This investment will enable ALZpath to continue generating clinical evidence and to launch an LDT version of the assay as ALZpathDx, which will be crucial for the timely detection of Alzheimer's disease. The ALZpath pTau217 assay is currently available for research use only (RUO) through Quanterix, as a kit and for services in the Quanterix Accelerator laboratory.

"The Alzheimer's Drug Discovery Foundation has had a transformative impact in advancing the understanding, diagnosis and treatment of Alzheimer's disease," said ALZpath Chief Scientific Officer and principal investigator, Dr. Andreas Jeromin. "Building on that legacy, and with their support, we can now continue expanding our efforts with the goal of ensuring broad clinical availability of ALZpathDx, which will be critical in facilitating timely and accurate detection, as well as providing scalable access to disease-modifying treatments for people living with Alzheimer's."

The ADDF is the only nonprofit dedicated to accelerating the discovery of drugs to prevent, treat and ultimately cure Alzheimer's, which affects more than fifty million people worldwide. Since 1998, the ADDF has awarded nearly $250 million in funding to over 720 Alzheimer's drug discovery and development programs, biomarker initiatives, and clinical trials in nineteen countries. 

"We know that tau deposits in the brain (as tangles) more closely correlate with cognitive function than beta-amyloid, meaning tau biomarkers will serve as a vital tool for physicians and researchers alike as Alzheimer's diagnostics and treatments continue to evolve," says Howard Fillit, MD, Co-Founder and Chief Science Officer at the ADDF. "Non-invasive tau blood tests that are able to accurately quantify the levels of specific types of tau protein in the blood, like ALZpath's, can impact patient outcomes by aiding in the early diagnosis and intervention for Alzheimer's disease."

ALZpath, Inc. will be attending the Alzheimer's Association International Conference (AAIC) in Amsterdam from July 16^th till July 20^th https://aaic.alz.org/overview.asp, and their presence at the conference will include several ALZpath pTau217 assay-related presentations.

For more information about ALZpath and ALZpathDx, please visit https://alzpath.bio/.

About ALZpath
ALZpath is a leading provider of innovative diagnostic solutions for Alzheimer's disease. With the novel ALZpath pTau217 Assay, ALZpath is transforming Alzheimer's disease diagnosis and monitoring, providing accurate and accessible tools for researchers and healthcare professionals worldwide.

About The Alzheimer's Drug Discovery Foundation (ADDF)
Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $250 million to fund over 720 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 19 countries. To learn more, please visit: http://www.alzdiscovery.org/.

About the Diagnostics Accelerator
The Diagnostics Accelerator, created in July 2018, is a $100 million global research initiative from partners including ADDF Co-Founder Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Scott, the Dolby family, the Charles and Helen Schwab Foundation, The Association for Frontotemporal Degeneration, among others, to develop novel biomarkers for the early detection of Alzheimer's disease and related dementias.

This research initiative is dedicated to accelerating the development of affordable and accessible biomarkers to diagnose Alzheimer's disease and related dementias and advance the clinical development of more targeted treatments. Through translational research awards and access to consulting support from industry experts, this program will challenge, assist and fund the research community in both academia and industry to develop novel peripheral and digital biomarkers.

Contact
Andreas Jeromin, PhD
Chief Scientific Officer
ALZpath, Inc.
Andreas@ALZpath.bio

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release are based on ALZpath's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause ALZpath's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in ALZpath's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, ALZpath assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.