Regulus expands development of RG-101 via collaboration with GSK

3 November 2015

US biotech company Regulus Therapeutics (Nasdaq: RGLS) says it has expanded development of RG-101, its wholly-owned, GalNAc-conjugated anti-miR that targets miR-122, through a clinical trial collaboration and formulation development agreement with UK pharma major GlaxoSmithKline (LSE: GSK).

No financial terms of the accord were disclosed. 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 hepatitis C virus (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.

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