Quanterix’s Simoa® Technology Drives Advances in Alzheimer’s Disease Research Presented at 2022 Clinical Trials on Alzheimer’s Disease (CTAD) Conference

Rhea-AI Summary

Quanterix Corporation (NASDAQ: QTRX) announced the role of its ultrasensitive Simoa technology in advancing clinical trials for Alzheimer’s disease (AD), presented at the 15th Clinical Trials on Alzheimer's Disease conference in San Francisco. Eisai and Biogen showcased Phase 3 trial results for lecanemab, highlighting biomarker engagement. Additional data from Eli Lilly and Janssen emphasized plasma biomarker utility. Quanterix aims to support future AD therapeutic trials with innovative testing tools, including FDA-designated Breakthrough Devices expected in 2023.

Positive

• Simoa technology significantly contributes to Alzheimer’s clinical trials.
• Phase 3 Clarity AD trial results demonstrate progress in Alzheimer's treatment.
• Quanterix to offer FDA-designated Breakthrough Devices for blood-based biomarkers in 2023.

Negative

• None.

Ultrasensitive Simoa^® technology and biomarkers continue to aid in the advancement of treatments in Alzheimer’s disease and other therapeutic areas for patients in urgent need

BILLERICA, Mass.--(BUSINESS WIRE)-- Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced that its Simoa^® technology has powered important advances in ongoing clinical trials for the treatment of Alzheimer’s disease (AD). The findings were presented at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference held in San Francisco, CA from November 29 to December 2, 2022.

In a historic moment in the fight against Alzheimer’s disease, Eisai Co., Ltd. and Biogen Corporation presented results from the Phase 3 clinical trial (Clarity AD) of lecanemab, an investigational drug aimed at slowing the progression of cognitive decline caused by AD. Target engagement and activity of the drug in downstream processes was explored with a panel of fluid biomarkers, including plasma pTau-181, GFAP and NfL, using Quanterix’s ultrasensitive Simoa assay kits. A report of the trial’s findings can be found in the New England Journal of Medicine.

In other encouraging data for AD therapeutics, topline results from Eli Lilly and Company’s Phase 3 TRAILBLAZER-ALZ 4 study findings were presented for donanemab, an investigational antibody that targets a modified form of beta amyloid plaque called N3pG. An updated readout of this ongoing trial is expected at the 2023 AD/PD™ meeting next spring.

In addition, a presentation was given on Janssen's Simoa plasma pTau-217 assay as a precision prescreening tool in the Phase 2 Autonomy anti-tau monoclonal Ab trial in early Alzheimer's disease. The talk highlighted the correlation of the assay with amyloid and tau PET status and pointed out its utility as a prescreening tool. The data can be found in this Alzheimer's Association research article. Researchers at Austin Health, Melbourne, also presented a paper looking at the two-year prognostic utility of Janssen’s Simoa pTau-217 assay in the Alzheimer's continuum.

An international CTAD Task Force on Blood Biomarkers led by academic and industry leaders was convened at CTAD on November 29 to explore the utility of plasma biomarkers in AD trials. During the session, topics of discussion included the use of blood-based biomarkers as a replacement for PET as a clinical trial entry criteria and for drug effects monitoring. The stature of amyloid PET, an expensive and not widely accessible gold standard testing modality for amyloid pathology, was questioned in view of the emerging high accuracy of plasma biomarkers. A CTAD blood-based biomarker workgroup was also convened on December 1 with a charter to map facilitators and barriers toward identifying specific workstreams to help drive the implementation of blood-based biomarkers in U.S. clinical practice. The project is scoped to provide meaningful work products in 2023 to facilitate clinical implementation of blood-based biomarkers.

“The results from Eisai’s Clarity AD clinical trial represent an exciting milestone for the treatment of Alzheimer’s disease,” said Masoud Toloue, CEO at Quanterix. “We’ve also seen that the use of blood-based biomarkers is growing rapidly in this field and will be integral in future therapeutic trial designs, as well as Alzheimer’s diagnostics. We are pleased that our technology is playing a key role in this rapid progress, including trial prescreening and enrollment of larger, more diverse populations, enhanced monitoring of drug effects and improvements in the diagnostic journey for Alzheimer’s patients.”

“We look forward to continuing to arm the pharma, academia and research fields with the tools to fuel breakthroughs in drug development and clinical validation for devastating neurodegenerative diseases like Alzheimer’s. These tools include our available CLIA-validated test for blood pTau-181 and a CLIA-validated test for NfL available in the first half of next year. Both of these tests were designated Breakthrough Devices by the FDA and are on IVD paths pending completion of clinical validation studies,” continued Toloue.

For more information about Quanterix’s work in neurology, please visit https://www.quanterix.com/therapeutic-areas/neurology/.

About Quanterix
From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. The Company’s Simoa^® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Limit of Quantification (LoQ) of conventional analog methods. Its industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology and infectious disease. Quanterix has been a trusted partner of the scientific community for nearly two decades, powering research published in more than 2,000 peer-reviewed journals. Find additional information about the Billerica, Massachusetts-based company at https://www.quanterix.com or follow us on Twitter and LinkedIn.

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 Quanterix’ 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 Quanterix’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Quanterix’ filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Quanterix assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221205005805/en/

Media:

PAN Communications

Lauren Force, (617) 502-4366

pan.quanterix@pancomm.com

Source: Quanterix Corporation

FAQ

What is the significance of Quanterix's Simoa technology in Alzheimer’s disease research?

Quanterix's Simoa technology enhances biomarker detection in Alzheimer’s research, aiding in the understanding and monitoring of disease progression.

What were the key findings from the Phase 3 Clarity AD trial presented by Eisai and Biogen?

The Phase 3 Clarity AD trial showed that lecanemab could slow cognitive decline in Alzheimer's patients, supported by biomarker engagement data.

What role do plasma biomarkers play in Alzheimer’s clinical trials?

Plasma biomarkers help in monitoring drug effects and serve as tools for trial prescreening and enrollment, making trials more efficient.

When can we expect the FDA-designated Breakthrough Devices for Quanterix’s blood tests?

Quanterix plans to release these FDA-designated Breakthrough Devices, including tests for pTau-181 and NfL, in the first half of 2023.