Regulus Therapeutics Reports Positive Phase 1b Topline Data from RGLS8429 Clinical Trial for the Treatment of ADPKD

June 24, 2024

DENVER, Colo., Jun 24, 2024 (247marketnews.com)- Regulus Therapeutics Inc. (Nasdaq:RGLS) reported positive topline results from the third cohort of patients in its Phase 1b MAD study, a double-blind, placebo-controlled trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics (PK/PD) of RGLS8429 in adult patients with ADPKD, which is evaluating RGLS8429 treatment across three different weight-based dose levels and one fixed dose level, including measuring changes in urinary polycystins 1 and 2 (PC1 and PC2), htTKV, cyst architecture, and overall kidney function.

In the third cohort, RGLS8429 was well tolerated with no safety concerns and continued evidence of a mechanistic dose response was observed following completion of 3 mg/kg dose level based on urinary PC1 and PC2.

“We are pleased to see the consistent mechanistic response and reduction in htTKV at the 3mg/kg dose level of RGLS8429 along with an appropriate safety and tolerability profile,” commented Preston Klassen, M.D., President and Head of Research & Development.  “These data support our ongoing and final 300 mg fixed dose cohort in this Phase 1b trial. We believe the data from this study will form the basis for a potentially pivotal Phase 2/3 study of RGLS8429 under an Accelerated Approval regulatory pathway to be discussed with the FDA.”

“Building on the positive results from our first two cohorts, these cohort 3 data, particularly the reduction in htTKV seen in the majority of patients, further strengthen our conviction in RGLS8429’s ability to potentially address the underlying, genetic cause of ADPKD,” CEO of Regulus Therapeutics, Jay Hagan, stated. “We anticipate requesting an End-of-Phase 1 meeting with the FDA in the fourth quarter of this year and look forward to providing a data update from the open-label fourth and final cohort of the Phase 1b MAD study by year-end.”

About 24/7 Market News
As a pioneer in digital financial market media, 24/7 Market News (24/7MN) is dedicated to the swift distribution of financial market news and information. 24/7 MN incorporates comprehensive corporate communications resources and tools to engage the investment community. Visit 24/7 Market News website here.

24/7 MARKET NEWS, INC Disclaimer
Please go to https://247marketnews.com/disclaimer/ for disclaimer information.

CONTACT:
24/7 Market News
Editor@247marketnews.com

Related news for (RGLS)

NASDAQ and NYSE quotes and data are delayed 15 minutes unless indicated otherwise. Market data and exchange information are provided for informational purposes only and is not intended for trading purposes. Neither 24/7 Market News Editors, 247 Market News, or data and content providers shall be liable for any errors or omissions, delays, misquotes or other market information relayed in any press materials. You should Use Realtime data to conduct due diligence before investing or trading, and trading in any stock is risky you could lose all your money.