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UK Startup ESP Diagnostics Eyes 2023 Launch for Early-Stage Parkinson's, Lewy Body Dementia Test


NEW YORK – ESP Diagnostics is developing a test for the early detection of Parkinson's and dementia with Lewy bodies that could reach the European clinical market by the end of 2023.

Established this year to commercialize technology developed at Newcastle University, ESP is positioning its extracellular synucleinopathic protein test as an alternative to conventional imaging-based approaches, It is also seeking to offer it as a service to pharmaceutical and biotechnology companies developing therapies for neurodegenerative diseases.

To accelerate diagnostic development, the Newcastle-based firm recently snagged a £272,000 ($339,000) Innovate UK grant that commenced in March and will run through February 2023. According to CEO Dale Athey, the grant will help put ESP's assay and protocols onto "proper commercial footing," by manufacturing the test under quality management systems, and carrying out additional validation of the test with partners, while establishing its service business with biotech and pharma companies. In parallel the company is seeking to raise £500,000 ($630,000) in seed investment.

"This grant will help us put those things in place that will be essential as we move toward full commercialization," Athey said.

Athey is a seasoned entrepreneur who is also a Wellcome Trust senior translator in residence at Newcastle, where he advises on developing early-stage discoveries into commercial ventures. He previously served as CEO of Orla Protein Technologies, a Newcastle-based life sciences company, and in 2009 was founder and CEO of diagnostics company OJ-Bio, which was a joint venture with Japan Radio Company.

When the work done around neurodegenerative disease at Newcastle reached a threshold, the university turned to Athey to bring it to market. "Essentially it is based on a lot of longstanding research in the university, but it got to a point where this test really met an unmet need," he said. The company has a worldwide, exclusive access to the IP, Athey added.

The work underlying ESP's test has a lengthy pedigree. Newcastle has been involved in neurodegenerative disease research for many decades. Pioneering work in the 1960s and 1970s was led by Bernard Tomlinson and Martin Roth, particularly around Alzheimer's disease. The university also hosts the Newcastle Brain Tissue Resource, a bank of over 1,500 brain tissue samples donated postmortem. Chris Morris, scientific director of the NBTR, who contributed to the development of ESP's technology, is a founder and involved in an advisory role with the company.

Much of the work behind the test was carried out by Marzena Kurzawa-Akanbi, a senior research associate in Newcastle's Biosciences Institute, and Lina Patterson, an investigator at Newcastle. Some of the scientists' work on ESP Diagnostics' approach was detailed in a paper in the journal Acta Neuropathologica last year. Kurzawa-Akanbi was the lead author on the paper and is the lead inventor of the approach.

In the paper, the authors describe obtaining extracellular vesicles produced by brain cells from Lewy body disease donor cerebrospinal fluid and frontal cortex samples from the NBTR, purifying the samples, and then characterizing the neurodegeneration-linked proteins alpha-synuclein and tau in them by using mass spectrometry and other approaches, including western blot and enzyme-linked immunosorbent assays.

As noted in the paper, these extracellular vesicles served as a measurable "pathological package" capable of inducing the aggregation of alpha-synuclein, which causes the buildup of Lewy bodies in the brain, leading to dementia with Lewy bodies or Parkinson's disease. The diseases are differentiated by where these aggregates form in the brain.

A brain scan, called a DaTscan, is currently the conventional approach to diagnose patients suffering from either disorder. The approach relies on injecting a radiopharmaceutical into a patient, followed by imaging using a PET scanner. Challenges exist regarding this technique though, related to access, accuracy, and cost. The Newcastle University team believes that by using its approach, it can detect early disease changes in cerebrospinal fluid by measuring the aggregation of the alpha-synuclein protein.

According to Kurzawa-Akanbi, while the Acta Neuropathologica paper described isolating EVs from cerebrospinal fluid, the research group has also been able to obtain them from plasma. These are then monitored in its alpha-synuclein aggregation assay.

"Extracellular vesicles from Lewy body disease patients make the alpha-synuclein aggregate, whereas control individuals' EVs do not," Kurzawa-Akanbi said in an email. "The test is so sensitive that we are able to detect the disease changes before the clinical symptoms occur," she claimed, adding the team was able to determine this by working on postmortem cerebrospinal fluid from individuals with a neuropathological report, as they were able to predict disease status, or what type of pathology they had.

According to Kurzawa-Akanbi, this technology can "easily be adapted to high-throughput screening of patient samples" in order to monitor them for extracellular vesicle-induced aggregation of the alpha-synuclein protein.

That is indeed the plan, according to Athey, with the objective of providing an early-stage, minimally invasive screening test that will allow diagnosed patients to make lifestyle adjustments and receive early treatment. Athey added that the potential ability to run the test on a blood draw was "quite game changing" for the company.

"We can see the sensitivity, the specificity we get from our method because of the use of extracellular vesicles, and that gives us some significant advantages and allows us to go into blood samples," Athey said. "We can detect this disease well in advance of the early symptoms that would be normally associated with a diagnosis from a clinical point of view," he added.

Currently, the test is run using standard laboratory plates and read by measuring changes in optical density. According to Athey, it takes about three days to run the assay using standard lab equipment, though the firm is focused on simplifying its assay. In comparison, it typically takes about two weeks to receive results from a DaTscan. He said the approach could challenge DaTscan, in that the latter is "very expensive and takes considerable time" and is "not that accurate, not something you can do on a routine basis." However, there is still a role for DaTscan and other imaging techniques, said Athey. In the future, the ESP test could be used to select patients for follow-up by DaTscan, he said.

He added that the company plans to achieve both a UK Conformity Assessed (UKCA) and CE-IVD mark for its test by the end of 2023. The EU is currently about to move to a new In Vitro Diagnostic Regulation that compels most IVD makers to seek clearance via designated notified bodies, and the UK, following its exit from the 27-member block, has instituted a new regulatory regime that will require a transition to its own certification mark by July 2023.

ESP is already offering its test as a service to companies developing disease-modifying therapies, Athey said. Its longer-term goal is to develop a diagnostics kit that can be sold worldwide, which will require regulatory approval in various regions. The company also believes its test could be used as a companion diagnostic by pharmaceutical and biotechnology firms that are engaged in the development of therapies for Parkinson's and dementia with Lewy bodies.

"Once the test can be rolled out to partner laboratories and others it changes the whole system," said Athey. "There aren't really any available tests to do this."

According to Athey, ESP believes there is sizable market potential for the offering. He said based on the firm's own analysis, there are currently about 750 clinical trials globally focused on Parkinson's and dementia with Lewy bodies, with an addressable diagnostics market for the test of more than 2 million patients per year.

There are other tests for Parkinson's and dementia with Lewy bodies in development or out on the market, though. San Francisco-based Amprion, for example, offers a test for Parkinson's and LBD, though the Amprion aggregation based assay is CSF based, not blood based. Another company, CND Life Sciences of Phoenix offers a test that detects folded phosphorylated alpha-synucleins in dermal layers of the skin. In March 2021, the company announced it had raised $2.4 million in a seed funding round. In February of this year, it closed a second seed round worth $5 million. Its test requires collection of three punch biopsy samples ahead of pathology testing.

ESP is not a one-indication company, however. Athey said that ESP could adapt its technology to test for Alzheimer's disease by measuring the tau protein in EVs, an overabundance of which is linked to the condition. "This is covered by our IP and would be an obvious next step along the line."