Regulus Therapeutics Inc. announced the prioritization of its promising, next-generation candidate, RGLS8429, for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). The Company recently completed the dosing period of the in-life portion of the IND-enabling toxicity studies for RGLS8429; anticipates submitting an Investigational New Drug application (IND); and subject to U.S. Food and Drug Administration (FDA) clearance, initiating a phase 1 study in the second quarter of 2022. Based on discussions with FDA and data from the second cohort of patients in the Phase 1b trial of first-generation RGLS4326 in ADPKD, the Company believes that a strategic prioritization of RGLS8429 represents a more judicious use of its resources, rather than continuing the development of RGLS4326 based on likely limitations on dose and duration of therapy.