The primary goal of the phase I study was to evaluate safety and pharmacokinetic properties of XTL-6865 in patients with chronic hepatitis C. XTL-6865, which targets the E2 envelope protein of the hepatitis C virus, is comprised of two fully-human monoclonal antibodies and is administered intravenously.
In this study, XTL-6865 was shown to be safe at high doses, up to 1200mg for five consecutive daily doses and a single dose of 2400mg. The study also enabled the company to establish the pharmacokinetic properties of XTL-6865 in patients with chronic hepatitis C. The study provided evidence of binding of the antibody to circulating virus and the formation of immune complexes(antibody-virus), believed to be important for virus neutralization in the serum.
“We believe that XTL-6865 could potentially play a role in certain clinical settings, such as preventing re-infection of hepatitis C following liver transplantation or in chronic hepatitis C patients who have low viral loads following treatment with other anti-hepatitis C drugs. We believe this is now an appropriate time to seek to out-license the compound,” said Ron Bentsur, CEO of XTL Biopharmaceuticals.