Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.ZymoGenetics has presented positive data from a Phase Ia clinical trial with PEG-Interferon lambda, or IL-29, in healthy volunteers showing that administration of single doses of IL-29 was well tolerated at doses that produced anticipated pharmacologic activity, including up-regulation of interferon response markers associated with antiviral effects.
Subscribe to our email newsletter
The primary objectives of this Phase Ia study were to characterize the safety, tolerability and pharmacokinetics of a single dose of IL-29 administered subcutaneously. A total of 20 subjects were treated with IL-29 at dose levels up to 7.5mcg/kg (n=17) or placebo (n=3). Administration of a single dose of IL-29 was associated with dose-related pharmacokinetic and pharmacodynamic effects and was well tolerated at biologically active doses.
Evidence of biological activity, including up-regulation of interferon response markers, was seen starting at doses of 1.5mcg/kg. These results suggest that antiviral activity against hepatitis C virus might also be seen at these dose levels.
Nicole Onetto, senior vice president and chief medical officer of ZymoGenetics, said: “Results from this single dose Phase Ia study in healthy volunteers support moving forward into a repeat dose Phase Ib study in patients with hepatitis C. The biologically active dose levels observed in the Phase Ia study have been used to design a Phase Ib study to evaluate the safety and antiviral effects of repeat dosing in patients with relapsed hepatitis C infection.”