Vertex to start Phase 3 trial of hepatitis drug

Vertex Pharmaceuticals Inc said today that it has received regulatory approval to begin a late-stage trial of its experimental hepatitis C drug telaprevir in patients who have failed previous treatments.

The Cambridge, Massachusetts-based biotechnology company is already testing the drug in patients who have not received previous therapy.

Earlier this year Vertex reported positive interim results from a Phase II, or mid-stage, trial of the drug in patients who had failed previous therapies, leading some analysts to speculate that the U.S. Food and Drug Administration might review the drug based on the Phase II data.

Vertex reiterated that it is on track with its previously stated plan of filing for approval of the drug in the second half of 2010 based on data from a Phase III, or late-stage, clinical trial of the drug in patients who have not previously been treated.

Zachry Barber, a spokesman for Vertex, said the company has not provided a timeline for completing its latest trial, called Realize, but said it expects to complete enrollment of 650 patients with the most common form of the liver-destroying disease in the first quarter of next year.
The trial will be conducted in the United States and Europe and compare two 48-week telaprevir-based regimens with a 48-week control arm.

Results from the mid-stage trial showed that 52 percent of treatment-failure patients who received telaprevir in combination with the standard treatment combination of interferon and ribavirin had undetectable levels of the hepatitis C virus after 36 weeks, compared with 30 percent of patients treated with standard therapy.

Vertex is developing telaprevir in partnership with drugmaker Johnson & Johnson. (Reuters)