US-based biopharmaceutical company Regulus Therapeutics has expanded its collaboration with GlaxoSmithKline (GSK), to initiate a Phase ll trial for evaluation of the combination of RG-101 and GSK's long-acting parenteral (LAP) formulation of GSK2878175, as a potential single-visit cure in patients chronically infected with hepatitis C virus (HCV).
RG-101 is Regulus' GalNAc-conjugated anti-miR that targets miR-122 to treat chronic hepatitis C virus infection.
The multi-centre, randomised, dose-ranging Phase ll trial will be conducted outside the US, with plans to begin in the fourth quarter of this year.
In the early part of this year, as part of the initial GSK-Regulus clinical trial collaboration agreement, Regulus started enrolling patients in an open-label, Phase II clinical trial combining RG-101 and GSK2878175 to treat HCV.
The trial aims to assess the potential to achieve sustained viral responses post treatment, with a single subcutaneous administration of 4mg/kg of RG-101 in combination with daily oral administrations of 20mg of GSK2878175, for up to 12 weeks in treatment-naïve patients chronically infected with HCV genotypes 1 and 3.
Regulus and GSK expect to report interim results from this trial by the end of this year.
Regulus noted that on the basis of predicted enrollment rates, interim results from the proposed Phase ll trial would be available in the second half of next year, enabling a potential initiation of another trial by the later half of next year.
As part of the initial collaboration, both the firms will equally share the costs associated with the trial.
Regulus Therapeutics president and CEO Dr Paul Grint said: "This is an important next step to advance the scientific understanding of the potential for a combination therapy to achieve a single-visit cure for HCV.
"The market research conducted to date indicates that a potential single visit cure would be a highly preferred product profile to existing regimens."