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MicroRNA Therapeutic Decreased Viral Load in Patients with Various HCV Genotypes
Interim results from an ongoing clinical trial revealed that an investigational microRNA therapeutic was well tolerated and safe for the treatment of hepatitis C virus infection, according to a company release from Regulus Therapeutics.
In the trial, currently underway in the Netherlands, RG-101 (Regulus Therapeutics), a GalNac-conjugated anti-miR targeting microRNA-122, was dosed at 2 mg/kg and administered to 14 patients with HCV. Treatment resulted in significant and sustained reductions in HCV RNA, including in patients with difficult-to-treat genotypes and those who experienced viral relapse after a prior interferon-based regimen.
Eight of the 14 patients were treatment naive. Six patients who experienced viral relapse after a previous interferon-based regimen received a single subcutaneous dose, while two patients received placebo, according to the release.
Results showed a mean viral load reduction of 4.1 log10 at day 29 (range –5.8 log10 to –2.3 log10) in all 14 patients assigned RG-101; six patients had HCV RNA levels below the limit of quantification at day 29 and three patients had HCV RNA levels below the limit of quantification by day 57, according to the release.
“RG-101 is the first microRNA therapeutic in clinical development to combine the most advanced RNA technologies from three leading RNA therapeutics companies; chemistry 2.5 from Isis, GalNAc conjugate from Alnylam and Regulus’ unique and proprietary chemistry, including the novel linker that facilitates the release of the parent oligonucleotide after hepatocyte uptake,” Neil W. Gibson, PhD, chief scientific officer at Regulus, said in the release.
Additional results are expected to be available in 2015, according to the release.