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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, after review of all available safety data, the Company initiated screening in the of the fourth cohort of patients in the Phase 1b MAD study of RGSL8429 for the treatment of ADPKD. Patients in the fourth cohort will receive an open label fixed dose of 300 mg of RGLS8429 every other week for three months. The study protocol has been amended to include up to 30 subjects in the fourth cohort in order to further examine potential impact on total kidney volume in patients with APDKD.
"After sharing positive topline data from cohort 2 that further validates RGLS8429's potential efficacy in ADPKD, we are moving to the fourth and final cohort of the Phase 1b MAD study," said Jay Hagan, CEO of Regulus Therapeutics. "This open label, fixed dose cohort will provide essential insight and data as we begin to think about study design for our potentially pivotal Phase 2 trial. Our team is looking forward to sharing further updates as they become available, including topline data from the third cohort in the middle of this year."
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 weight-based dose levels, including measuring changes in urinary polycystins PC1 and PC2, height-adjusted total kidney volume (htTKV), cyst architecture, and overall kidney function. PC1 and PC2 are the protein products of the PKD1 and PKD2 genes respectively and have been shown to inversely correlate with disease severity. The Company amended the protocol to include a fourth cohort of up to 30 subjects who will receive a fixed dose of 300 mg of RGLS8429 administered every other week for three months.
More information about the MAD clinical trial is available at clinicaltrials.gov (NCT05521191).
Posted In: RGLS
