Regulus Therapeutics Inc. announced the dosing of the first patient in the second cohort of the Phase 1b MAD study of RGLS8429 for the treatment of ADPKD. 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.

Patients in the second cohort will receive 2 mg/kg of RGLS8429 or placebo every other week for three months. The first cohort was dosed at 1 mg/kg of RGLS 8429 or placebo every other week For three months. All available blinded safety data for the second cohort will be reviewed prior to proceeding to the third cohort.

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