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InterMune Initiates Phase 1a Clinical Trial Evaluating Hepatitis C Protease Inhibitor ITMN-191 in Collaboration with Roche
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Tuesday December 19, 12:40 pm ET
Source: InterMune, Inc.
BRISBANE, Calif., Dec. 19 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) announced today that the company and its partner Roche have received approval of the European Clinical Trial Authorization (CTA) for ITMN-191, the NS3/4A protease inhibitor, and have initiated a Phase 1a clinical trial evaluating ITMN-191 for the treatment of chronic hepatitis C virus (HCV) infection. The Phase 1a trial will assess safety, tolerability, pharmacokinetics and food affect in a double-blind, placebo-controlled single ascending dose study. The study is being conducted at one clinical trial site in Europe and will enroll approximately 74 healthy volunteers. InterMune expects to dose the first patient with ITMN-191 sometime in early January 2007.
"Our preclinical research indicates ITMN-191 has the potential to be an important addition to therapy for HCV patients because of its favorable cross resistance and potency profiles, as well as pharmacokinetic results that support the exploration of twice-daily oral dosing in future clinical trials," said Lawrence M. Blatt, Ph.D., Chief Scientific Officer of InterMune. "The initiation of the Phase 1a human trial for ITMN-191 moves our HCV protease inhibitor program one step closer to the proof-of-concept Phase 1b clinical study in patients infected with HCV. We look forward to providing updates as we advance the program with our partner Roche."
About HCV and HCV Protease Inhibitors
According to the Centers for Disease Control and Prevention (CDC), an estimated 3.9 million Americans (1.8%) have been infected with HCV, of whom 2.7 million are chronically infected. According to the World Health Organization (WHO), it is estimated that there are 170 million people worldwide afflicted with this disease. Currently available therapies are insufficient, creating a need for the development of novel therapeutic approaches. The HCV NS3/4A protease is an attractive drug target because of its potential involvement in viral replication and suppressive effects on host response to viral infection. Inhibitors of the HCV protease, such as ITMN-191, represent a promising new class of drugs for HCV.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes two Phase III programs evaluating possible therapeutic candidates for treatment of patients with IPF. The INSPIRE trial is evaluating Actimmune (interferon gamma-1b) and the CAPACITY program is evaluating pirfenidone. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 in Phase 1a, a second-generation HCV protease inhibitor program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
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