Regulus HCV Candidate On Clinical Hold After Second Jaundice Report
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.
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The micro-RNA-focused biotech believes the jaundice seen with HCV candidate RG-101 was specific to the drug, not the target or delivery system, but is switching focus to other promising programs, such RG-012 for Alport syndrome.
Although it is on FDA clinical hold to resolve safety concerns about jaundice, RG-101 has shown the ability to significantly reduce the length – and perhaps cost – of HCV therapy when combined with current direct-acting antivirals.
Regulus Therapeutics Inc. reported positive interim Phase II results for its microRNA-targeting injection RG-101 in a hepatitis C virus (HCV) market that's dominated by highly effective oral drugs, but the company may be able to reach a goal that's been illusive for Gilead Sciences Inc. and its competitors – curing HCV patients with a four-week regimen.