Regulus Starts Phase 1b Trial of RGLS8429 for Treatment of Autosomal Dominant Polycystic Kidney Disease

 The Phase 1b MAD study is a double-blind, placebo-controlled trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics (PK/PD) of RGLS8429 in adult patients with ADPKD. The study will evaluate RGLS8429 treatment across three different dose levels, including measuring changes in polycystins, height-adjusted total kidney volume (htTKV), cyst architecture, and overall kidney function. The second cohort is being dosed at 2 mg/kg of RGLS8429 or placebo every other week for three months. No issues were identified in cohort two based on the review of all available blinded safety data, allowing advancement to cohort three. The safety review incorporated available data from all 12 patients in the second cohort including several who had completed the dosing schedule. Patients in the third cohort will receive 3 mg/kg of RGLS8429 or placebo every other week for three months. 

More information about the MAD clinical trial is available at clinicaltrials.gov (NCT05521191).

https://www.biospace.com/article/releases/regulus-therapeutics-announces-first-patient-dosed-in-third-cohort-of-phase-1b-multiple-ascending-dose-mad-clinical-trial-of-rgls8429-for-the-treatment-of-autosomal-dominant-polycystic-kidney-disease-adpkd-/