Neuron23, QIAGEN Developing Test to Find Patients for LRRK2 Inhibitor

Clinical trials of experimental therapy NEU-723 expected to begin by year's end

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by Somi Igbene, PhD |

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Neuron23 and QIAGEN have joined forces to develop a companion test to predict the response of patients to Neuron23’s experimental treatment for Parkinson’s disease, called NEU-723.

“QIAGEN’s blood-based test will help to identify patients with Parkinson’s disease who are likely to respond to Neuron23’s LRRK2 inhibitor,” Nancy Stagliano, PhD, CEO of Neuron23, said in a company press release.

“The development of a companion diagnostic identifying this sub-population of Parkinson’s disease patients will de-risk the clinical development of Neuron23’s LRRK2 inhibitor and help identify individuals who may benefit from this disease-modifying therapy,” Stagliano added.

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Parkinson’s disease is caused by the progressive loss of neurons that produce dopamine, a major brain chemical messenger. This leads not only to the disease’s hallmark motor problems, but also to nonmotor symptoms such as mood disorders, constipation, cognitive impairment, sleep disturbances, and depression.

Genetic and environmental factors are thought to influence a person’s risk of developing Parkinson’s. While most cases occur in people without a family history of the condition, mutations in the LRRK2 gene ­are one of the most frequent causes of both sporadic and familial Parkinson’s.

All these genetic variants seem to increase the activity of the resulting LRRK2 protein, which is found in neurons and many cells in the body. As such, blocking LRRK2’s activity could have therapeutic potential in Parkinson’s disease.

What is NEU-723?

NEU-723, in late stages of preclinical development, is a small molecule that works by potently and selectively blocking the activity of LRRK2.

The therapy is able to cross the blood-brain barrier, a highly selective membrane that tightly regulates what substances from the bloodstream can enter the brain, and crossing it is often a challenge for brain-targeting therapies.

In March, Neuron23 announced that it expected to begin clinical trials of NEU-723 by the end of 2022.

Under the terms of the agreement, QIAGEN will develop and validate a test that detects a combination of biomarkers identified by Neuron23 that together predict patient response to a LRRK2 suppressor.

These biomarkers were identified by integrating biomarker, genetic, and clinical data from observational studies into the company’s machine learning models.

Machine learning is a type of artificial intelligence that uses algorithms to analyze data, learns from its analyses, and then makes predictions.

“This collaboration combines the leading expertise of Neuron23 in drug discovery, data science, and machine learning with QIAGEN’s long-standing experience and global leadership in companion diagnostic development,” Stagliano said.

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Jonathan Arnold, vice president and head of oncology (cancer) and precision diagnostics at QIAGEN, said that “the collaboration with Neuron23 shows the rapid momentum precision medicine is gaining in disease areas outside oncology.”

“Our expertise in blood-and [next generation sequencing-based] molecular testing from sample to insight will enable Neuron23 to run a clinical trial for a drug candidate that may have the potential to modify the course of an inexorable neurodegenerative disease in a genetically defined population,” Arnold added.

Next generation sequencing is a powerful tool that enables the rapid identification of mutations in several genes simultaneously.

“We are excited about this partnership as this is the first companion diagnostic to be developed for Parkinson’s disease,” Stagliano said.

By developing NEU-723 and the companion diagnostic test simultaneously, the companies will be able to submit applications to the U.S. Food and Drug Administration seeking premarket approval of the test and the therapy’s approval for Parkinson’s at the same time.

The collaboration agreement also covers options for the future development of additional companion diagnostics.

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