Earlier this year, up-and-coming biotech Neuron23 nominated its first clinical candidate, a small-molecule drug designed to inhibit the LRRK2 gene, mutations in which are commonly linked to inherited cases of Parkinson’s disease and, less commonly, non-genetic forms of the disease.
Though the drug is still in the late stages of preclinical development, Neuron23 is already looking ahead to how it’ll be used in clinical settings, and it has tapped Qiagen to help with that implementation, the drugmaker announced this week.
As the drug’s development continues, Qiagen will get started on building a companion diagnostic that’ll be able to predict how responsive Parkinson’s patients might be to an LRRK2 inhibitor—making it the first companion diagnostic developed for the neurodegenerative disease, according to Neuron23 CEO Nancy Stagliano, Ph.D.
Though Parkinson’s still has no cure, drugs like Neuron23’s proposed candidate are meant to help alleviate some symptoms of the disease.
The test will employ Qiagen’s next-generation sequencing and dig through each patient’s genome to spot the biomarkers Neuron23 has linked with responsiveness to its LRRK2 inhibitor.
By starting to build the blood-based test now, before the drug has even entered clinical trials, Neuron23 and Qiagen are aiming to be able to submit them both to the FDA for approval at the same time. The test will also be used during those clinical trials to help improve testing.
“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 said.
Additionally, under the terms of their new collaboration, Neuron23 and Qiagen have pledged to continue working together to develop other companion diagnostics in the future, subject to the biotech’s further clinical development plans. Financial terms of the agreement weren’t disclosed.
Qiagen has already garnered FDA approval for 10 companion diagnostics developed in tandem with other drugmakers, and it also has ongoing collaboration agreements with more than two dozen pharma and biotech companies to churn out even more tests.
Its list of FDA-approved PCR tests include several of its Therascreen diagnostics, such as those designed to be used alongside drugs for non-small cell lung cancer, colorectal cancer, urothelial cancer and breast cancer from Janssen, Novartis, Amgen and more.