AltPep Receives FDA Breakthrough Device Designation for SOBA-AD, A Simple Blood Test for the Detection of Alzheimer’s Disease

Breakthrough designation reinforces the significant potential of SOBA-AD assay to address the unmet need in Alzheimer’s Disease (AD) detection

SOBA-AD assay is designed to selectively detect toxic oligomers that trigger a cascade of events associated with AD, including cognitive impairment and neurodegeneration

SEATTLE--(BUSINESS WIRE)--AltPep Corporation, a privately held biotechnology company developing early disease-modifying treatments and detection tools for amyloid diseases, today announced the U.S. Food and Drug Administration (FDA) granted the company Breakthrough Device designation for its SOBA-AD diagnostic in development for Alzheimer’s disease (AD). The inclusion in the FDA Breakthrough Devices Program means that AltPep can expect prioritized review of the submission of their device. The long-term potential for the SOBA-AD assay lies in its ability to detect disease early, even before symptoms arise. Early detection may lead to more effective treatments that limit cognitive decline in AD patients.

“Receiving FDA Breakthrough Device designation is an extremely important recognition that will support our efforts to help fill an unmet medical need and bring the SOBA-AD test initially to aid in the diagnosis of AD in patients that present mild cognitive impairment in memory-care and clinical settings,” said Valerie Daggett, Ph.D., Founder and CEO of AltPep. “Existing FDA-cleared diagnostic tests for AD reflect amyloid-beta plaques and neurofibrillary tangles in the brains of patients; the SOBA-AD test in plasma aims to detect the early molecular triggers of the disease, before plaque formation.”

Breakthrough Device designation is granted to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions¹. Alzheimer’s disease is the most prevalent form of dementia and estimates indicate there are currently 6 million Americans living with AD and this number is projected to grow to 13 million by 2050².

About SOBA-AD

A hallmark of Alzheimer’s disease is the aggregation of the amyloid-beta peptide. AltPep’s proprietary SOBA-AD assay, a simple blood test, detects toxic forms of this peptide at AD’s earlier stages. Current assessment technologies focus on symptoms or other markers that are only detectable once damage has occurred. Research has shown that early diagnosis of Alzheimer’s disease may enable access to treatments that could improve cognition and enhance quality of life. AltPep is also working to develop SOBIN treatments, potential disease-modifying therapies for amyloid diseases for treatment in concert with early detection.

About AltPep Corporation

AltPep is developing early disease-modifying treatments and detection tools for amyloid diseases by targeting one of the earliest molecular triggers – toxic soluble oligomers. These oligomers are associated with many diseases, including neurodegenerative diseases and type 2 diabetes. Decades of scientific research by the Daggett Research Group culminated in the discovery of a novel protein structure, alpha-sheet, the foundation of AltPep’s innovative approach.

Our lead SOBA-AD program aims to identify pre-symptomatic cases of Alzheimer’s disease. In parallel, AltPep’s proprietary SOBIN-AD program seeks to target and neutralize toxic soluble oligomers associated with the disease. For more information, please visit www.altpep.com or follow us on LinkedIn.

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1. U.S. Food and Drug Administration (FDA): Breakthrough Devices Program. Available from: https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
2. Alzheimer’s Association, 2021 Alzheimer’s Disease Facts and Figures, https://www.alz.org/alzheimers-dementia/facts-figures

MacDougall
Susan Sharpe
ssharpe@macdougall.bio
781-235-3060