Neuron23™ Inc., an early stage biotechnology company focused on developing precision medicines for genetically defined neurological and immunological diseases, and QIAGEN ( NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a collaboration to develop a companion diagnostic for Neuron23’s LRRK2 inhibitor for Parkinson’s disease.
Under the Master Collaboration Agreement, QIAGEN will develop and validate a clinical trial assay that will detect a combination of biomarkers discovered by Neuron23 that together predict the responsiveness of Parkinson’s disease patients to a LRRK2 inhibitor. The partnership will support the clinical development of Neuron23’s drug candidate that is currently in the late stages of preclinical development. Subject to further clinical development, the agreement also covers options for the future development of additional companion diagnostics.
The assay for this collaboration will be integrated into a next-generation sequencing (NGS) workflow that leverages QIAGEN’s Sample to Insight capabilities. Parallel development of the diagnostic assay and the therapeutic will allow the companies to submit the application to the U.S. Food and Drug Administration (FDA) for premarket approval (PMA) of the NGS companion diagnostic test in tandem with the new drug application (NDA) for Neuron23’s LRRK2 inhibitor.
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“We are excited about this partnership as this is the first companion diagnostic to be developed for Parkinson’s disease. 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,” said Nancy Stagliano, Ph.D., CEO of Neuron23. “QIAGEN’s blood-based test will help to identify patients with Parkinson’s disease who are likely to respond to Neuron23’s LRRK2 inhibitor. 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. We are excited to be working with an industry leader on the first companion diagnostic developed for Parkinson’s disease.”