The phase I trial is a placebo controlled, randomized, dose escalating study, which will evaluate the safety, tolerability and antiviral activity of single and multiple doses of XTL-2125.
The study will enroll 48 patients into 6 cohorts comprised of 8 patients each of which 2 are placebo patients. Each patient will receive a single dose, followed by a 14-day multi-dosing regimen commencing one week after the single dose administration.
XTL-2125 is an oral non-nucleoside hepatitis C virus polymerase inhibitor. In preclinical studies, XTL-2125 has demonstrated robust activity against the hepatitis C virus in both cell-based and in-vivo systems. In addition, the drug has demonstrated a good safety profile in multiple animal species.
“XTLbio is in the unique position of having 2 novel compounds – XTL-2125 and XTL-6865 – in clinical trials in patients with chronic hepatitis C. We look forward to generating antiviral activity data from both studies over the next 12 months,” commented Ron Bentsur, XTLbio’s CEO.