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Regulus Commences Dosing RG-101 In Healthy Volunteers In Phase I Study

LA JOLLA, Calif., March 5, 2014 /PRNewswire/ -- Regulus Therapeutics Inc. ( NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that it has commenced dosing RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 ("miR-122") in healthy volunteer subjects in a Phase I clinical study.  The primary objective of the study is to evaluate safety and tolerability of RG-101 and the secondary objectives are to evaluate pharmacokinetics, viral load reduction and any impact an oral direct-acting antiviral may have on the pharmacokinetics of RG-101.  

"We are very pleased to have dosed our first human subject, advancing Regulus into a clinical-stage company," said Neil W. Gibson, Ph.D., Chief Scientific Officer of Regulus. "We continue to be encouraged by the preclinical data seen to date and believe that RG-101 has the potential to be a best-in-class host factor agent, specifically due to its pan-genotypic properties, including demonstrated efficacy in the hard to treat HCV genotype 3, and the potential for a once monthly dosing regimen.  We look forward to reporting data from the Phase I clinical study of RG-101 by the end of this year."

About the RG-101 Phase I Clinical Study

The Phase I clinical study of RG-101 will have four parts: (i) a single ascending-dose study in healthy volunteer subjects; (ii) a multiple-ascending dose study in healthy volunteer subjects; (iii) a single-dose drug-drug interaction study of RG-101 in combination with an approved oral direct-acting antiviral ("DAA") in healthy volunteer subjects; and (iv) a single-dose study in HCV patients to assess the safety and viral load reduction, which is designed to demonstrate human proof-of-concept.  Up to approximately 100 healthy volunteer subjects and HCV patients are planned to be enrolled in the Phase I study, which is being conducted in the Netherlands. 

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