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RG-101 Monotherapy Reduced Viral Loads in Patients with HCV
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Many treatment-naive patients with hepatitis C virus infection had reduced mean viral loads after monotherapy with RG-101, an anti-miR targeting miR-122, for the treatment of hepatitis C virus infection, according to a press release.
RG-101 (Regulus Therapeutics) was given in a single dose of 4 mg/kg to 14 patients with HCV; 12 treatment-naive and two who experienced relapse after previous treatment. Two other patients received placebo. By day 29, all 14 patients showed a mean viral load reduction of 4.8 log (range –5.8 to –3). After 57 days, nine of 14 patients had HCV RNA levels below the limit of quantification, according to the release.
“These results demonstrate a significant breakthrough in the treatment of HCV,” Hendrik W. Reesink, MD, PhD, associate professor in the department of gastroenterology and hepatology at the Academic Medical Center in the Netherlands, said in the release. “These landmark studies were conducted with a high level of novelty and practical clinical importance. All 28 patients treated with one administration of RG-101 responded and more than 50% had HCV RNA levels below the lower limit of quantification at day 57.”
In a previous cohort, 16 patients with HCV were treated with 2 mg/kg of RG-101 and all 14 patients experienced a viral load reduction of 4.1 log at 29 days; eight were treatment-naive, six relapsed after a different previous treatment and two received placebo. Six of 14 patients had HCV RNA levels below the limit of quantification at 29 days and three maintained below the limit of quantification levels at 57 days, according to the release.
“The profile of RG-101 has been significantly enhanced with these top-line data, making it an ideal pan-genotypic asset to investigate further in combination with all classes of oral agents to shorten the duration of treatment, increase patient compliance and maintain viral response and also as monotherapy in certain underserved HCV populations,” Kleanthis G. Xanthopoulos, PhD, president and CEO of Regulus, said in the release. “With the promising data reported today, our confidence in our ability to treat diseases with microRNA therapeutics is higher than ever and we look forward to continuing to execute our ‘Clinical Map Initiative’ goals for RG-101 and our microRNA therapeutics pipeline.”