AltPep Study Published in Nature Journal, Scientific Reports, Further Affirms Potential of Blood Test to Detect Alzheimer's Disease

AltPep Corporation ("AltPep" or the "Company"), a privately held biotechnology company dedicated to early disease-modifying treatments and detection tools for amyloid diseases, today announced that the peer-reviewed Nature journal Scientific Reports has published new results from the Company's evaluation of its novel SOBA-AD blood test, aimed at detecting Alzheimer's disease (AD).

The data, consistent with an earlier study, further support the potential value of the SOBA-AD test as a promising blood-based tool for the selective detection and confirmation of AD. The SOBA-AD blood test targets toxic soluble oligomers, an early molecular trigger of amyloid diseases, with the ultimate goal of identifying patients with the disease years before symptoms manifest.

In the report titled "Performance of SOBA-AD blood test in discriminating Alzheimer's disease patients from cognitively unimpaired controls in two independent cohorts", 265 blinded plasma samples from two independent cohorts were tested at two different sites. The SOBA-AD blood test identified AD patients from cognitively unimpaired (CU) subjects with 100% sensitivity, >95% specificity, and >98% area under the curve (95% CI 0.95-1.00).

Commenting on the published results, Valerie Daggett, Ph.D., Founder and CEO of AltPep said, "Moving forward, AD will be defined biologically at the molecular level vs by clinical symptoms alone. These results for our simple SOBA-AD blood test support the goal of earlier, pre-symptomatic detection of patients with AD. AltPep's technology stands apart from others because it rationally targets a specific nonstandard protein structure called alpha-sheet, which is present in toxic oligomers that form both early and throughout the disease process. This novel test, now run successfully at multiple locations, has the potential to have profound implications as a biomarker for AD clinical trials as well as a diagnostic for earlier treatment of the disease."

Results

In the new study, the SOBA-AD blood test effectively differentiated clinically diagnosed AD patients from CU controls with high specificity and sensitivity across 265 samples. Combining these results with prior research, a comprehensive analysis of 644 samples consistently exhibited high performance metrics, with sensitivity ranging from 99 to 100%, specificity from 95 to 100%, and an area under the curve from 98 to 100%. In addition to expanding the cohorts from one to three and including two independent sites (AltPep and the University of Washington) with separate equipment and operators, this study increased diversity among the samples.

In the prior research, a number of CU subjects tested positive who later converted to Mild Cognitive Impairment (MCI) or AD, as confirmed by clinical evaluation or neuropathology. These results support the potential for early detection in preclinical stages. In this study, five CU controls tested positive for AD according to the assay. While confirmatory data were unavailable for these five cases, it is plausible these subjects also have pre-symptomatic disease. Follow-up is still being pursued.

About AltPep's SOBA Diagnostics and SOBIN^® Therapeutics

SOBA diagnostics are highly sensitive, simple blood tests in development to aid in the diagnosis of amyloid diseases. SOBIN therapeutics are in development for use in concert with early detection to target and neutralize the toxic soluble oligomers associated with amyloid diseases.

AltPep has received Breakthrough Designation from the FDA for its SOBA-AD blood test for Alzheimer's disease. The inclusion in the FDA Breakthrough Devices Program means that AltPep can expect prioritized review of the submission of the diagnostic test.

About AltPep Corporation

AltPep is developing groundbreaking disease-modifying treatments and detection tools for amyloid diseases by targeting early molecular triggers: toxic soluble oligomers. Our customized, synthetic peptides are designed to bind selectively to toxic oligomers in order to both detect and neutralize them throughout disease progression. AltPep's emphasis is on early, pre-symptomatic detection and treatment. Our lead programs focus on Alzheimer's and Parkinson's diseases, with other amyloid diseases on the horizon. AltPep's goal is to change the course of these debilitating diseases that affect over a billion people around the globe.

Decades of scientific research by the Daggett Research Group at the University of Washington provided the foundation for AltPep's innovative approach.

For more information, please visit AltPep.com or follow us on LinkedIn.