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Regulus' four-week HCV regimen achieves cure rates as high as 100% in mid-stage study, investors unimpressed; shared down 5%

  • Micro cap Regulus Therapeutics (RGLS -4.9%) slumps on average volume after its announcement of Phase 2 data on lead product candidate RG-101 for the treatment of hepatitis C virus (HCV) infection failed to excite investors.
  • The ongoing mid-stage study is assessing a four-week once-daily treatment regimen of RG-101, in combination with Gilead Sciences' (GILD +0.5%) Harvoni (ledipasvir/sofosbuvir) or Janssen's (JNJ +0.1%) Olysio (simeprevir) or Bristol-Myers Squibb's (BMY +0.4%) Daklinza (daclatasvir) in 79 treatment-naive patients with HCV genotypes 1 and 4 infection.
  • Cure rates, defined as sustained virologic response 12 weeks following the end of treatment (SVR12), were 100% for the combination with Harvoni, 96.3% for the combination with Olysio and 91.7% for the combination with Daklinza.
  • 24 weeks after the end of therapy, however, the cure rates dropped to 80.0% and 88.9%, respectively, for Olysio and Daklinza but remained at 100% for Harvoni, clouding the picture for RG-101's efficacy.
  • RG-101 is a microRNA therapeutic, specifically a GalNAc-conjugated anti-microRNA targeting microRNA-122. MicroRNAs are small bits of RNA, typically 20 - 25 nucleotides long, that do not encode proteins but regulate gene expression. Researchers believe as many as two-thirds of human genes are regulated by microRNAs.

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