The trial has been designed to assess RGLS8429 in adult ADPKD patients. Credit: Nephron / commons.wikimedia.org.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

See Also:

Patients in cohort two will be administered with 2mg/kg of RGLS8429 or placebo every other week for three months.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.