NEW YORK – Molecular diagnostics company Asuragen announced on Monday that it is collaborating with genetic medicines developer Wave Life Sciences to develop and commercialize companion diagnostics for Wave's investigational allele-selective therapeutic programs for Huntington's disease.
Asuragen will use its AmplideX PCR technology to develop companion diagnostics based on a SNP phasing methodology Wave is currently using in Huntington's clinical trials and in a previously conducted observational study. The companion diagnostic tests will phase CAG repeats in the HTT gene with two different SNPs targeted by Wave's WVE-120101 and WVE-120102 investigational therapeutic programs.
HTT CAG repeats are a hallmark of Huntington's. They cause a progressive breakdown of nerve cells in the brain, leading to the deterioration of patients' physical and mental abilities.
The companies are aiming to develop scalable SNP phasing technology to support potential global Phase III development programs and future commercialization of therapies for the disease. The tests would be used to aid clinicians in selecting Huntington's patients for treatment with one of Wave's compounds by identifying the SNPs that are linked to the CAG-expanded allele.
Financial terms of the deal were not disclosed.
"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," Jaya Goyal, Wave's vice president of bioanalytics, pharmacology, and biomarker development, said in a statement.
Wave is currently conducting two Phase Ib/2a clinical trials, PRECISION-HD1 and PRECISION-HD2, for patients with Huntington's. The trials are evaluating 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 intact. Wave expects to report topline data from the PRECISION-HD2 and PRECISION-HD1 trials by the end of 2019 and early 2020, respectively.