With separate Phase III studies ongoing to test its marketed therapy Actimmune against idiopathic pulmonary fibrosis and ovarian cancer, InterMune Inc. said a Phase II trial evaluating the drug against liver fibrosis (cirrhosis) failed to meet its endpoint.
Wall Street apparently hadn't expected much from the study with its ambitious goal: reversal of advanced cirrhosis. The company's stock (NASDAQ:ITMN) rose 2 cents Wednesday to close at $21.18.
"We're not going to do additional liver fibrosis studies, but we are evaluating a clinical plan about the combination of Actimmune [interferon gamma-1b] and Infergen [interferon alfacon-1]," said Griffin Murray, associate director of corporate strategy and communications for Brisbane, Calif.-based InterMune. That combo has shown preliminary promise against chronic hepatitis C virus in patients who failed to show any significant response to peg-interferon alpha-2 plus ribavirin, disclosed in December.
The cirrhosis trial was designed to determine safety as well as the ability of Actimmune to reverse fibrosis in chronic HCV patients with advanced liver disease when administered for 48 weeks. Its missed primary endpoint was reversal of liver fibrosis as determined by the Ishak histology scoring system.
"In retrospect, we could have designed a study that was more appropriate," Murray told BioWorld Today, such as giving the drug to patients with milder cases of cirrhosis over a longer period of time.
"That probably would have made sense," he said. "These are very sick patients, and we put a pretty high hurdle on it."
The results mean nothing with regard to the ongoing Phase III studies, Murray said. In IPF, the endpoint is survival of mild to moderate cases, he said, and "ovarian cancer is a whole different ball of wax, given that [Actimmune is administered as] adjunctive therapy."
The IPF trial "just had our first patient in December," he said. "It's a two-year enrollment and two years to treat." The ovarian cancer trial is expected to complete enrollment in the first half of this year, with data in the first half of 2005. (See BioWorld Today, Dec. 17, 2003.)
Actimmune is on the market for chronic granulomatous disease and severe malignant osteopetrosis.
"Over the past couple of quarters we've had stable Actimmune revenues," Murray said. The financial report for 2003 is due in a week, and InterMune has offered guidance of $135 million to $150 million in sales of the drug for the year, he said.