Regulus Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application for RGLS | RGLS Message Board Posts


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Msg  811 of 829  at  5/11/2022 10:59:45 AM  by

Steve_382


Regulus Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application for RGLS8429

 Dosing in this quarter and data in second half of the year. Sounds a bit better than I expected. Looks like we are still going to have pretty rough reverse split. I actually picked up more shares this morning just under $0.20 per share. Who knows how smart that was.
 
 
 
May 11, 2022
Regulus Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application for RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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

SAN DIEGO, May 11, 2022 /PRNewswire/ -- 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 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," said Jay 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.

 


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Msg # Subject Author Recs Date Posted
812 Re: Regulus Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application for RGLS8429 arthurs1 0 5/11/2022 11:47:45 AM
816 Re: Regulus Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application for RGLS8429 Steve_382 1 5/12/2022 12:21:50 PM
818 Re: Regulus Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application for RGLS8429 Steve_382 1 5/17/2022 9:29:54 AM


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