BRISBANE, Calif., Sept. 29 /PRNewswire-FirstCall/ -- InterMune, Inc. today announced that its partner Roche has begun dosing in a Phase 1b multiple ascending dose (MAD) study of ITMN-191 (RG7227) boosted by low-dose ritonavir in patients chronically infected with hepatitis C virus (HCV) genotype-1.
Ritonavir boosting is an option to enhance and improve pharmacokinetic profiles of protease inhibitors. It is well established in the treatment of HIV where it leads to more convenient dosing, reduced resistance development and high efficacy. Not all HCV protease inhibitors are suitable for ritonavir boosting. However, as InterMune announced on August 6, 2009, ITMN-191 showed high promise in a Phase 1 single ascending dose (SAD) study in healthy volunteers. Important PK parameters showed marked improvement and significant increases in AUC and drug concentrations were observed. There were no remarkable safety findings.
"We and our partner Roche are very pleased by the performance of ITMN-191 in twice-daily regimens when un-boosted with ritonavir," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "However, if results of ritonavir boosting of ITMN-191 in human volunteers are replicated in this study of HCV patients, the approach could lead to achieving more sustained exposures with lower twice-daily doses of ITMN-191 or perhaps allow once-daily administration. Either of these two possibilities could provide patients a regimen with more convenient administration and with the clinical advantages associated with sustained drug exposure."
The objective of the MAD study is to determine the pharmacokinetic (PK), viral kinetic and safety profiles of ascending doses of once-daily and twice-daily ITMN-191 co-administered with low doses of ritonavir and standard dose Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin) in HCV-infected patients and for 14 days. On August 6, the company announced results of a Phase 1 study of ITMN-191 co-administered with low dose ritonavir in healthy volunteers.
About ITMN-191/RG7227
ITMN-191/RG7227 is a potent, macrocyclic inhibitor of HCV NS3/4A protease activity currently in Phase 2b development. The compound is being developed in collaboration with Roche. ITMN-191 has produced multi-log10 reductions in HCV levels in chronic HCV patients, when administered for 14 days as monotherapy. When ITMN-191 was combined with Pegasys and Copegus, or the NS5B polymerase in Phase 1b studies, it reduced HCV viral loads below the limit of quantification in the majority of study-treated patients. The safety and antiviral activity of ITMN-191 is also under clinical investigation in combination with the NS5B nucleoside inhibitor RG7128 in the INFORM clinical development program. To date, ITMN-191 has been safe and well tolerated in these studies.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has an R&D portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes pirfenidone for which a Phase 3 program in patients with IPF (CAPACITY) has been completed and the compound is currently in the pre-registration stage. The company also has a research program focused on a pirfenidone analog named ITMN-520. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as RG7227 at Roche) that entered Phase 2b in August of 2009 and a second-generation HCV protease inhibitor research program. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to anticipated product development timelines. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements.
Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the SEC on March 16, 2009 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the long, expensive and uncertain clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues or delays in anticipated timing of the regulatory approval process; (ii) risks related to failure to achieve the clinical trial results required to commercialize our product candidates; and (iii) risks related to timely patient enrollment and retention in clinical trials. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at www.intermune.com.
All trademarks used or mentioned in this release are protected by law.
SOURCE InterMune, Inc.
CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228, jgoff@intermune.com
Web site: http://www.intermune.com/
