Brief: Regulus Therapeutics Announces Successful Completion Of Pre-Ind Meeting With FDA For Rgls8429

Regulus Therapeutics

20/01/2022 22:56

Jan 20 (Reuters) - Regulus Therapeutics Inc  RGLS.O :
    * REGULUS THERAPEUTICS ANNOUNCES SUCCESSFUL COMPLETION OF
PRE-IND
MEETING WITH FDA FOR RGLS8429
    * REGULUS THERAPEUTICS INC - ON TRACK TO SUBMIT IND AND
INITIATE
PHASE 1 STUDY IN Q2 2022
    * REGULUS THERAPEUTICS INC - TO INCLUDE EVALUATION OF
TREATMENT
IMPACT ON SLOWING CYSTIC KIDNEY EXPANSION
    * REGULUS THERAPEUTICS INC - FDA PROVIDED OVERALL AGREEMENT
WITH
TRIAL DESIGN AND LENGTH OF PHASE 1 STUDY, INCLUDING PROPOSED
STARTING DOSE FOR RGLS8429
    * REGULUS THERAPEUTICS INC - UPDATED CLINICAL PLANS AGREED
TO WITH
FDA INCLUDE EXTENDING DOSING TO THREE MONTHS IN EACH COHORT OF
ADPKD PATIENTS
    * REGULUS THERAPEUTICS -  UPDATED CLINICAL PLANS AGREED TO
WITH
FDA INCLUDE INCLUSION OF MEASUREMENTS OF CHANGES IN HTTKV BY
MAGNETIC RESONANCE IMAGING
    * REGULUS -  UPDATED CLINICAL PLANS AGREED TO WITH FDA
INCLUDE
TESTING HIGHER DOSES OF RGLS8429 THAN WERE TESTED WITH
FIRST-GENERATION COMPOUND

Source text for Eikon:  ID:nPn9FMsCqa 
Further company coverage:  RGLS.O 

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