FDA Puts Hold on Vertex Hepatitis Study

July 26, 2013

By Bill Berkrot

(Reuters) - Vertex Pharmaceuticals Inc said U.S. health regulators placed a partial clinical hold on a mid-stage study of an experimental oral hepatitis C treatment because of potential liver problems.

Vertex said the U.S. Food and Drug Administration took the action after the Phase II study in Europe of its VX-135 in combination with the standard hepatitis drug ribavirin showed elevated liver enzymes in three patients taking the 400 milligram dose of its drug.

As a result of the hold on the U.S. clinical trial, the Massachusetts-based biotechnology company said it was unable to begin dosing patients in a planned U.S. study aimed at testing VX-135 at 200 mg.

"We are committed to continuing to work closely with the FDA to provide the data needed to support evaluation of a 200 mg dose of VX-135 in the U.S.," Robert Kauffman, Vertex's chief medical officer, said in a statement.

The 400 mg arm of the European study was discontinued and the patients' liver enzymes returned to what they had been prior to entering the trial, Vertex said.

A U.S. study evaluating 100 mgs of VX-135 was not affected, the company said.

VX-135 is also being studied at 100 mg and 200 mg in combination with Bristol-Myers Squibb Co's daclatasvir, a highly promising hepatitis drug from a different class of oral medicines.

Vertex also makes hepatitis C treatment Incivek (telaprevir). But that drug must be taken with the often difficult to tolerate injected drug interferon to provide high cure rates.

New all oral treatment regimens for hepatitis C hold promise of high cure rates without the need for interferon and the flu-like symptoms that come with it.

The first of those are expected to become available in 2014 from other companies and Vertex has been playing catch-up.

"With our ongoing studies in the U.S., Europe and now New Zealand with VX-135 and daclatasvir, our strategy in hepatitis C is unchanged - to develop an all-oral therapy that provides a high cure rate across multiple hepatitis C genotypes," Kauffman said.

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