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Regulus Reports Third Quarter 2013 Financial Results and Recent Highlights
Date:11/13/2013

#160; "We are pleased to have advanced our microRNA therapeutic pipeline by presenting key data at scientific meetings, preparing to enter the clinic with RG-101 and working towards the nomination of a second microRNA candidate for clinical development."

Recent Corporate Highlights

  • Presented Positive Preclinical Data on RG-101, a GalNAc-conjugated anti-miR Targeting miR-122 for the Treatment of HCV, in Late-Breaking Poster at AASLD Meeting. At the 64th Annual American Association for the Study of Liver Diseases (AASLD) meeting, Regulus presented positive data from completed preclinical studies evaluating RG-101 for in vitro and in vivo potency, pharmacokinetic/pharmacodynamics, toxicology and safety pharmacology and inhibition of HCV replication. Pharmacologic potency of RG-101 was significantly enhanced by approximately 20 fold in vivo in both mice and non-human primates, relative to the unconjugated oligonucleotide of RG-101. RG-101 is rapidly taken up in the liver and metabolized to the active oligonucleotide, which has an approximately 14 day tissue half-life. In addition to the potency studies, Regulus tested the efficacy of RG-101 to reduce HCV viral load titer in a human chimeric liver mouse model infected with HCV. Up to a 2 log reduction in HCV viral load titer was observed, which is similar to that observed for oral direct-acting antivirals as monotherapy in this mouse model. The duration of action observed for RG-101 supports the potential for a once-a-month dosing regimen. Additionally, RG-101 has demonstrated an excellent preclinical safety profile and is well tolerated to date. Regulus expects to file a regulatory application for this program in the near term and expects to commence clinical studies in man in early 2014.
  • Presented Positive Preclinical Data on microRNA-21 (miR-21) in Alport Syndrome at The American Society of Nephrology (ASN) Kidney Week Meeting; Program Subject to Exclusive
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  • SOURCE Regulus Therapeutics Inc.
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