Regulus Reports Positive Topline Data From First Cohort Of Patients In Phase 1b Study Of RGLS8429

(RTTNews) - Regulus Therapeutics Inc. (RGLS) reported positive topline results from the first cohort of patients in Phase 1b MAD study of RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease or ADPKD. The study is designed to evaluate safety, pharmacokinetics, disease related urinary biomarkers, including urinary polycystin 1 or PC1 and polycystin 2 or PC2, height-adjusted total kidney volume, and cyst imaging biomarkers. In the study, increases in both PC1 and PC2 biomarkers were observed. The data are consistent with what was observed with the company's first-generation compound, RGLS4326.

The company noted that Urinary polycystin exhibits an appropriate PK/PD correlation to potentially serve as a key pharmacodynamic biomarker for the program targeting miR-17 to treat ADPKD.

Regulus Therapeutics expects data from the second cohort, dosed at 2mg/kg, in the first quarter of 2024.

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