Regulus Therapeutics has concluded enrolment of subjects in the first cohort of Phase lb multiple-ascending dose (MAD) trial of RGLS8429 to treat autosomal dominant polycystic kidney disease (ADPKD) patients.
The double-blind, placebo-controlled trial has been designed to assess RGLS8429’s safety, tolerability, pharmacokinetics and pharmacodynamics (PK/PD) in adult ADPKD patients.
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It will examine the safety and PK/PD of the treatment in three different dose levels, including calculating changes in polycystins, height-adjusted total kidney volume (htTKV) and overall function of kidney.
The first cohort is being given RGLS8429 1mg/kg dose or placebo every other week for a period of three months.
Dosing patients in the second cohort is expected to commence after examining cohort one safety data, which is anticipated to be released next month.
Patients in cohort two will be administered with 2mg/kg of RGLS8429 or placebo every other week for three months.
Regulus Therapeutics CEO Jay Hagan said: “Completion of enrolment in the first cohort of the Phase lb MAD study is an important milestone in the development of this novel treatment for ADPKD.
“Topline data from the first cohort are expected to be available around the end of the third quarter of this year.”
In September last year, Regulus reported positive topline data from its Phase I single-ascending dose (SAD) trial of RGLS8429 for the treatment of ADPKD.
