Collaboration investigates RG-101, GSK28787175 combo for HCV

Regulus Therapeutics announced it has expanded its clinical trial agreement with GlaxoSmithKline and will conduct a phase 2 study evaluating its drug RG-101 with GSK28787175 for chronic hepatitis C virus infection.

Researchers will assess RG-101 (Regulus), an anti-miR targeting miR-122, in combination with GSK28728175 as a single visit cure in patients who have chronic HCV, according to a press release. The trial will be conducted outside of the U.S. and is set to begin in the fourth quarter of 2016.

“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,” Paul Grint, MD, president and CEO of Regulus said in the release. “The market research conducted to date indicates that a potential single visit cure would be a highly preferred product profile to existing regimens.”

Regulus and GSK will share costs associated with the study equally and neither party has any further obligations or commitments to each other beyond the expanded clinical collaboration agreement, according to the release.

“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. Together with Regulus, we are taking another step forward to proving this novel concept,” Zhi Hong, senior vice president and head of infectious diseases therapy area at GSK, said in the release.

In a previous phase 2 clinical trial of RG-101, interim results indicated that the drug in combination with Harvoni, Olysio or Daklinza was safe and effective for reducing HCV over 4 weeks.

Interim results of the clinical trial are expected to be available in 2017.

Disclosure: Grint is employed by Regulus. Hong is employed by GSK.