Molecular diagnostics company Asuragen is teaming up with biotech Wave Life Sciences to help develop a new diagnostic for its experimental Huntington’s disease (HD) therapy.
This comes after life sciences company Wave struck a pact with Japanese Big Pharma Takeda last year with a focus on a series of difficult-to-treat neurological disorders. This collab has seen the pair work on antisense oligonucleotides for genetically defined neurological diseases.
Oligonucleotides are designed to reduce the expression of disease-promoting proteins or to transform the production of dysfunctional mutant proteins into the production of functional proteins, in what researchers hope will translate into a treatment.
This has seen Wave focus on amyotrophic lateral sclerosis, frontotemporal dementia, spinocerebellar ataxia type 3 and Huntington’s.
Now, it’s enlisting Asuragen to help develop its HD assets: WVE-120101 and WVE-120102, which are stereopure oligonucleotides designed to lower the mutant HTT mRNA transcript by targeting one of two SNPs while leaving the wild-type transcript relatively intact.
Wave expects to report top-line data from the PRECISION-HD2 and PRECISION-HD1 trials, in phase 1 and 2 tests, by end of this year and early 2020, respectively. The deal with Asuragen will see the pair work on phase 3 development and possibly beyond into commercialization.
Asuragen’s AmplideX PCR tech is already used in multiple neurological disorders and will be put to use to develop companion diagnostic tests that size and phase HTT CAG repeats with two different SNPs targeted by Wave.
“These SNPs are represented alone or together in up to 70% of the HD population,” the company said, adding: “The intended use of the tests is to aid clinicians in selecting HD patients who would be appropriate for one of Wave’s HD compounds by identifying the SNPs that are uniquely linked to the CAG-expanded allele.”
“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,” said Jaya Goyal, Ph.D., vice president of bioanalytics, pharmacology and biomarker development at Wave Life Sciences.
“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 personalized medicine,” added Matthew McManus, M.D., Ph.D., president and CEO of Asuragen.