Molecular diagnostics firm Asuragen has collaborated with Wave Life Sciences to develop a companion diagnostics (CDx) for Huntington’s disease (HD) gene therapies.
The diagnostics will support Wave’s investigative allele-selective therapeutic programmes, which aims to target the underlying genetic cause of HD.
HD is a genetic disorder that causes the progressive breakdown of nerve cells in the brain, as a result of an expansion of CAG repeats in the HTT gene. It hinders a person’s physical and mental abilities and currently has no cure.
The collaboration will leverage its repetitive sequence diagnostic expertise to provide scalable SNP phasing to support potential global Phase 3 development programmes.
The molecular diagnostics firm will be developing CDx tests for two SNPs targeted by Wave’s WVE-120101 and WVE-120102 candidates. The candidates are observed alone or together in more than two-thirds (70%) of Huntington’s patients.
At present, the safety, tolerability, pharmacokinetics and pharmacodynamics of the companion treatments is being assessed by Wave in coordinated Phase 1b / 2a multicentre, randomised, double-blind, placebo-controlled studies.
Wave Life Sciences bioanalytics, pharmacology, and biomarker development vice-president Jaya Goyal said: “Our partnership with Asuragen for companion diagnostic development was a natural fit in light of their deep knowledge and expertise with challenging molecular targets, diagnostic regulatory experience and their growing presence in the neurogenetics testing market.”
Asuragen will utilise its AmplideX PCR technology to develop companion diagnostic tests.
Asuragen president and CEO Matthew McManus said: “We’re pleased to be a part of this new category of potential therapies and to have a positive impact on such a devastating disease.
“Developing a companion diagnostic for Wave’s novel allele-selective silencing program in HD is a great example of how our products will continue to advance personalised medicine.”
Wave expects to report data from PRECISION-HD2 by the end of the year and through PRECISION-HD1 trials by early 2020.
The tests will be used to aid clinicians in selecting Huntington’s patients for treatment with one of Wave’s compounds by identifying the SNPs linked to the CAG-expanded allele.