The thymalfasin treatment group did not achieve statistical significance for the primary endpoint of sustained virological response (SVR) as assessed in the primary analysis population, ie, the intent-to-treat (ITT) population.
In the prospectively defined secondary population of patients who completed the full course of 48 weeks of treatment with thymalfasin in addition to pegylated interferon alpha-2a (peg-IFN-2a) and ribavirin (completer population), the primary endpoint achieved statistical significance.
In the ITT population (552 patients), 12.73% of the patients in the thymalfasin treated group achieved an SVR at week 72 of the trial, versus 10.47% in the control group (p=0.407). In the completer population (182 patients), the difference in SVR between the thymalfasin treated group and the control group achieved statistical significance (p=0.048).
Friedhelm Blobel, president and CEO of SciClone Pharmaceuticals, said: “We are disappointed that the study did not reach its primary efficacy endpoint in the ITT population. Nevertheless, the data seen in the completer population suggest a potential benefit of using thymalfasin in patients who completed the full course of treatment.”