(NASDAQ: RGLS) REGULUS THERAPEUTICS INC. is up more than 60% on FDA news at lunch time. Heavy trading.


Regulus Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application for RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

PR Newswire   “Press Releases US – English”

Company remains on track to initiate Phase 1 clinical study in second quarter 2022

SAN DIEGO, May 11, 2022 /PR News wire (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the “Company” or “Regulus”), today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application for RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD), enabling the Company to initiate its planned Phase 1 clinical study of RGSL8429 in healthy volunteers.

“With FDA’s acceptance of our IND and the Phase 1 trial preparations well underway, we look forward to advancing this program which ultimately may provide a transformative treatment option for patients with ADPKD,” saidJay Hagan, President and Chief Executive Officer of Regulus Therapeutics. “We are on track to initiate the study in the second quarter and expect data from the healthy volunteer study and initiation of dosing in patients with ADPKD in the second half of this year.”

The Company will conduct a Phase 1 single-ascending dose (SAD) study in healthy volunteers to assess safety, tolerability and pharmacokinetics of RGLS8429. Following the SAD study, the Company plans to initiate a Phase 1b multiple ascending dose (MAD) study in adult patients with ADPKD to assess safety, tolerability and pharmacokinetics of RGLS8429, and to evaluate the efficacy of RGLS8429 treatment across three different dose levels including changes in polycystins, cystic kidney volume (htTKV), and overall kidney function.

Read entire article here: https://www.prnewswire.com/news-releases/regulus-therapeutics-announces-fda-acceptance-of-investigational-new-drug-ind-application-for-rgls8429-for-the-treatment-of-autosomal-dominant-polycystic-kidney-disease-adpkd-301544735.html


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