SAN DIEGO – Parkinson’s disease, Alzheimer’s disease, Lewy Body Dementia – neurological conditions that affect people as they age are often as difficult to distinguish and diagnose as they are to treat. One San Diego diagnostics company is looking to change that with a unique test that may be able to identify certain diseases before they even manifest symptoms.
Amprion – a blend of “amplify” and “prion” – is developing tests that detect certain prions, or abnormal, pathogenic agents that are transmissible and are able to induce abnormal folding of specific normal cellular proteins, that are now thought to be the root causes of several neurological conditions.
The company’s SYNTap Biomarker Test is a first-in-class-qualitative Laboratory
Developed Test and the only seed amplification assay available to aid the diagnosis of neurodegenerative diseases such as Parkinson’s, Lewy Body Dementia and Alzheimer’s with Lewy Body variant that are characterized by abnormal folding of alpha-synuclein pathways.
The test is being adopted by major medical centers, major research studies and large pharma companies, said Amprion CEO Dr. Russ Lebovitz.
“Our main customer base is pharma companies wanting to develop drugs. They need it to know what patients have before going into clinical trials,” he added.
Amprion’s test is currently being used by “single digit thousands” of people, Lebovitz said. “But we just launched the test. 2023 was our first full commercial year. By the end of the year, the second half of 2023 we were net cash flow positive.”
Lebovitz estimates that a least a million people in the U.S. could benefit from the test. Roughly 40% of Alzheimer’s, 85% of Lewy Body and 85% Parkinson’s cases could be classified as affected by the protein Amprion tests for.
“The gap between 1 million and 10,000 is still substantial but we built an infrastructure that can grow very rapidly over the next five years as the value of this to those patients is realized,” he said. “Getting from 8,000 to 800,000 tests per year is not a minor feat, but we did anticipate that when building. Our facilities in San Diego can reach 600,000 tests per year.”
Amprion was founded in 2007 and has raised more than $8 million in grant funds and $14 million in investor capital, which was mostly used to support building the company’s two San Diego facilities. Lebovitz said the company is currently raising capital to hire more people and build out a commercial team.
“To reach people we need to reach their doctors. We’re looking for approximately another $15 million that gets us to very rapid profitability,” he said, adding that the several thousand tests Amprion sold last year to more than a dozen major drug companies was accomplished with no sales team. “It was all inbound from the research.”
Mad Cow to Alzheimer’s
Amprion’s test is based on the research of Claudio Soto, Amprion co-founder and CSO, who also serves as professor of neurology and director of the George and Cynthia Mitchell Center for Alzheimer’s disease and related Brain Disorders at the University of Texas Medical School in Houston.
Soto was looking at Mad Cow Disease, which is caused by misfolded prions. That research ultimately led to adapting PCR testing technology and methodology to amplify proteins, which became the basis of the company.
Amprion’s test was recently validated in a study by the Michael J. Fox Foundation and Parkinson’s Progression Markers Initiative that showed it helped detect
Parkinson’s disease in individuals before cardinal movement symptoms arise.
And in August of last year, Amprion was contracted by the National Institutes of Health (NIH) Intramural Research Program’s Center for Alzheimer’s and Related Dementias (CARD) to study the levels of misfolded alpha-synuclein proteins in people with Alzheimer’s disease.
“Amprion has developed a cerebrospinal fluid assay for misfolded alpha-synuclein, which is thought to be the cause of Parkinson’s disease as well as the pathology of Lewy Body disease, the latter being commonly associated with Alzheimer’s Disease,” said Mike Weiner, MD, principal investigator for the Alzheimer’s Disease Neuroimaging Initiative, a large research study with the goal of validating biomarkers for use in Alzheimer’s Disease clinical treatment trials.
“The collaboration will help determine the extent to which alpha-synuclein occurs in patients with various stages of Alzheimer’s Disease and in unaffected aged individuals. This project has the potential to improve clinical diagnosis of dementia and advance clinical trials of treatments for Alzheimer’s Disease.”
Amprion is also looking to expand globally after it fundraises to scale its commercial team. “We’re looking to get into Europe in 2024 and then into Asia in 2025, Lebovitz said.
CEO: Dr. Russ Lebovitz
HEADQUARTERS: San Diego
BUSINESS: Diagnostic tests for neurological conditions
FUNDING: $8 million (grants); $14 million (investor capital)
NOTABLE: Amprion’s tests were initially conceived as a way to better study Mad Cow Disease