NEW YORK ─ Bio-Techne and Regulus Therapeutics on Wednesday announced a collaboration to support biomarker assay development and biomarker analysis for the clinical development of Regulus' RGLS4326, an autosomal dominant polycystic kidney disease (ADPKD) treatment.
Regulus has used two Bio-Techne branded product lines, ProteinSimple and Exosome Diagnostics, to help with its clinical trial patient testing, Bio-Techne said.
Minneapolis-based Bio-Techne added that the collaboration involves developing biomarker assays to support the assessment of levels of polycystin 1 (PC1) and polycystin 2 (PC2) using its fully automated Simple Western instrument to read out results. Its Exosome Diagnostics business ─ with clinical laboratories in Waltham, Massachusetts, and Munich ─ isolates and analyzes exosomes to measure RNA, cell-free DNA, and proteins to explore and identify biomarkers, Bio-Techne said.
Patients with ADPKD have been reported to have low levels of PC1 and PC2, the proteins encoded by the PKD1 and PKD2 genes, due to a mutation in polycystic kidney disease genes.
RGLS4326 is a first-in-class anti-miR-17 therapy in Phase 1b clinical development in ADPKD patients. The Phase 1b trial is an adaptive design, open-label, multiple-dose study in up to three cohorts of patients with ADPKD.
Investigators expect to enroll up to nine patients in a first patient cohort who will receive RGLS4326 every two weeks over six weeks, and they anticipate that results for the cohort will be available by the end of Q1 2021.