SciClone Pharmaceuticals has reported topline results from the Phase IIb clinical trial of SCV-07 for the treatment of hepatitis C.

The study was designed to evaluate the safety and immunomodulatory effects of SCV-07 as a monotherapy and in combination with ribavirin in relapsed hepatitis C patients.

The results showed that SCV-07 was safe and well-tolerated at both administered doses.

Topline results, however, showed that SCV-07 did not meet the study’s primary efficacy endpoint, which was defined as a two-log reduction in viral load from baseline level.

A secondary measure of efficacy, defined as a reduction in viral load of greater than 0.5 log from baseline level, was observed in 38.5% of the low-dose patients and in 44.4% of the high-dose patients.

In addition, no patients in the low-dose group achieved greater than a one-log reduction, while three of the high-dose patients achieved greater than a one-log reduction in viral load.

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By GlobalData

SciClone president and CEO Friedhelm Blobel said that due to the rapidly changing landscape of effective treatments which increase the complexity and risks of developing drugs in chronic hepatitis C, the company had decided not to continue development in this indication.

“On another front, we continue to be excited about the potential for SCV-07 in the prevention of oral mucositis in patients with head and neck cancer, and the initiation of our phase IIb study, which should begin by early 2011,” Blobel added.

The Phase IIb multicentre, multi-dose, open-label study enrolled relapsed hepatitis C patients. They were grouped into two cohorts of 20 patients each, in which each patient received SCV-07 at a dose of either 0.1 mg/kg or 1.0 mg/kg.