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Regulus Expands Development of RG-101 through Collaboration with GSK

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Regulus Therapeutics Inc. has announced that it has expanded development of RG-101, Regulus' wholly-owned, GalNAc-conjugated anti-miR that targets miR-122, through a clinical trial collaboration and formulation development agreement with GlaxoSmithKline ("GSK").

The companies plan to conduct a Phase II study to evaluate the combination of RG-101 and GSK2878175, an investigational non-nucleoside NS5B polymerase inhibitor, for the treatment of HCV.

Concurrently, GSK will work on developing a long-acting parenteral for injection ("LAP") formulation of GSK2878175 which could improve patient compliance through reduced dosing intervals and potentially extend opportunities for HCV therapeutic intervention.

This LAP formulation of GSK2878175 may be used in additional clinical trials together with RG-101 following completion of the planned Phase II study, although any additional studies are not covered by the collaboration agreement.

"We are pleased to work with GSK to advance the scientific understanding of the potential for a combination regimen co-administered all at once to treat HCV," said Paul Grint, M.D., President and CEO of Regulus. "The study to be conducted under this clinical collaboration represents one of many approaches Regulus is actively pursuing with RG-101. We remain committed to realizing the full potential of RG-101 and we look forward to initiating the combination study in the first quarter of 2016."

Zhi Hong, Senior Vice President and Head of the Infectious Diseases Therapy Area, GSK commented, "Building on GSK's long-acting formulation expertise and know how, we are excited about the potential of this combination to provide people living with HCV a new treatment option that could be delivered in a single visit."

Regulus will be responsible for conducting a multi-center, open-label Phase II study to evaluate the potential to achieve sustained viral responses post treatment with a single subcutaneous administration of 4 mg/kg of RG-101 in combination with daily oral administrations of 20 mg of GSK2878175 for up to 12 weeks in treatment-naive patients chronically infected with HCV genotypes 1 and 3.

This study will be conducted outside the United States and is planned to begin in the first quarter of 2016. Neither Regulus nor GSK has any further obligations or commitments beyond the contemplated study under the clinical collaboration agreement.