Benzinga | Feb 10, 2021 08:08AM EST

Regulus Therapeutics Announces Completion Of Enrollment In First Cohort Of Phase 1b Clinical Trial Of RGLS4326 For The Treatment Of Patients With Autosomal Dominant Polycystic Kidney Disease

LA JOLLA, Calif., Feb. 10, 2021 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced it has completed enrollment of the first cohort of patients into its Phase 1b clinical study of RGLS4326. The Phase 1b is an adaptive design, open-label, multiple dose study in up to three cohorts of patients with ADPKD. The study is designed to evaluate the safety, pharmacokinetics, and changes in levels of polycystin 1 (PC1) and polycystin 2 (PC2) in patients with ADPKD administered RGLS4326 every other week for a total of four doses. The dose level for the first cohort is 1mg/kg of RGLS4326 and the dose level for the second cohort is 0.3mg/kg. The third and final cohort will be dosed at a level to be determined based on the results of the first two cohorts. Concurrent with completion of enrollment in the first cohort and based on the review of the available interim safety data, the first patient of the second cohort has received the first dose of RGLS4326.