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Regulus HCV Candidate On Clinical Hold After Second Jaundice Report

 
• By Joseph Haas

First jaundice adverse event was deemed unlikely to be connected to treatment with RG-101, and the second patient presents similar profile of overall health and co-morbidities.

Although the issue seems unlikely to be related to the study drug, Regulus Therapeutics Inc.'s mid-stage hepatitis C candidate RG-101 has been placed on clinical hold by FDA after a second patient presented a serious adverse event of jaundice.

It's a potentially serious setback for the clinical-stage microRNA specialist, which is trying to elbow into the competitive HCV space...

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