RG-101: Additional Phase I data
Top-line data from 14 patients with HCV infection in the second cohort of Part 4 of a 4-part, placebo-controlled, Dutch Phase I trial showed that a single subcutaneous dose of 4 mg/kg RG-101 led to a mean viral load reduction of 4.8 log10 at day 29. Additionally, 9 patients had HCV RNA levels below the limit of quantification at day 57. The cohort included 12 treatment-naïve patients and 2 patients who had relapsed after treatment with an interferon-containing regimen. Additional data from the first cohort of 14 patients with HCV genotypes 1, 3 or 4 infection in Part 4 of the trial showed that 4 patients receiving a single subcutaneous dose of 2 mg/kg RG-101 were classified as “target not detected” at day 85. Regulus said that 2 of the patients who had HCV RNA levels below the limit of quantification at day 57 relapsed shortly thereafter. ...