Life Sciences Insight

Bio-Techne and Regulus Therapeutics to Develop Assays for Kidney Disease Treatment

[360dx – 12/2/20] 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.

Source – 360dx