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InterMune Reports Presentation of Triple Combination Study of ITMN-191 at European Association for the Study of the Liver (EASL)

Didn't see it posted here yet. Intermune had already released the results and no additional new information appears in the PR but of note here is more detail on the 2b design (highlighted) specificially the dosing which I had not seen before.

http://finance.yahoo.com/news/InterMune-Reports-prnews-15024721.html?.v=1

Results inform selection of doses, regimens to be explored in Phase 2b study -

-- Phase 2b program anticipated to begin in summer 2009 --

COPENHAGEN, April 24 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today announced that results from a 14-day Phase 1b clinical study of ITMN-191 (R7227) in combination with the current standard of care were presented today by Stefan Zeuzem, M.D., of the J.W. Goethe University, Frankfurt, Germany, in an oral presentation at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark. The study explored the use of ITMN-191 in combination with Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin) for 14 days of treatment in hepatitis C virus (HCV) treatment-naive patients infected with HCV genotype 1. ITMN-191 is an HCV protease inhibitor being developed in collaboration with Roche.

Among the highlights of his presentation, Dr. Zeuzem reported:

* The combination of ITMN-191 plus the standard of care for 14 days resulted in rapid and sustained reductions in HCV RNA.
* Substantial antiviral activity was observed in both the q8h and q12h dosing cohorts; the most rapid declines in HCV RNA occurred in the ITMN-191 900 mg q12h dosing cohort.
* Viral rebound was not observed in any patient receiving treatment with ITMN-191 plus Pegasys and ribavirin.
* ITMN-191 plus standard-of-care therapy was safe and generally well tolerated.
* The findings support the continued evaluation of ITMN-191-based combination regimens of twice-daily and three-times-daily dosing in patients with chronic HCV infection.

Dr. Zeuzem, protocol chair of the study, said, "Based on the totality of the viral kinetic data, the q12h and q8h regimens delivered very convincing results and appeared to perform very comparably in this 14-day study. The safety and tolerability profile of ITMN-191 in both the earlier monotherapy study and in the present triple combination study was also encouraging, as no issues of concern were observed. We look forward to the Phase 2b study to determine if the very promising profile of ITMN-191 observed will be confirmed."

InterMune noted that a Phase 2b triple combination trial of ITMN-191 is planned for initiation in the summer of 2009. A Phase 1 trial of ITMN-191 and polymerase inhibitor R7128 (INFORM-1 Study) is currently underway.

Steven Porter, M.D., Ph.D., Chief Medical Officer of InterMune, said, "The Phase 1b triple combination study was designed to inform the dose selection and study design of the ITMN-191 Phase 2 program. The Phase 2b program will study both q12h regimens (600mg and 900mg q12h) and a q8h regimen (300mg q8h) and both 12-week and 24-week treatment durations. We believe that the viral kinetic and safety results reported today provide evidence that ITMN-191 has the potential to deliver superior sustained virologic response (SVR) rates in patients chronically infected with the hepatitis C virus."

Viral Kinetic Performance

After 14 days of triple combination therapy, the median change in HCV RNA from baseline exceeded 5 logs in five of the six cohorts and was -5.4 log and -5.7 log in the best performing q12h and q8h cohorts, respectively. Considering all cohorts, HCV RNA was below the limit of quantification in nearly three-quarters (71%, or 32 of 45) of patients who received treatment with ITMN-191 after only 14 days of treatment. In all q12h and q8h cohorts, reductions in HCV RNA occurred rapidly and there was no evidence of viral rebound during ITMN-191 treatment.

Safety and Tolerability Profile

ITMN-191 was generally safe and well tolerated. There were no serious adverse events (SAE) or Grade 4 adverse events (AEs) during treatment with ITMN-191. AEs reported during study treatment (ITMN-191 or placebo) were predominantly mild to moderate in severity, typically consistent with the well-described AE profile of standard of care (SOC) and none led to treatment discontinuation.

Only four Grade 3 AEs were reported during study treatment, two of which (sciatica and back pain) were deemed by the investigator to be unrelated to ITMN-191. The other two were neutropenia and indirect bilirubin elevation. Neutropenia occurred with a similar pattern, frequency and severity in the placebo and ITMN-191 groups. Minor and transient elevations in indirect bilirubin levels were observed in a small number of placebo and ITMN-191 patients and were deemed not clinically significant by the investigator. There were no other laboratory or ECG findings during study treatment that were attributable to ITMN-191.

Phase 1b Triple Combination Trial Design

The Phase 1b randomized, double-blind, placebo-controlled, 14-day triple combination study was conducted in treatment-naive patients chronically infected with HCV genotype 1. The study objectives were to assess the safety, pharmacokinetic and viral kinetic effects of various doses and regimens of ITMN-191 for 14 days in combination with Pegasys and Copegus compared to treatment with Pegasys and Copegus alone. Patient follow-up continued for 30 days following the completion of study treatment.

INFORM-1 Program

In November 2008, Roche, InterMune and Pharmasset initiated the first all-oral combination study of direct-acting antivirals (DAAs) in the absence of interferon or ribavirin, known as the INFORM-1 study. Interim results from the INFORM-1 study will be presented in an oral late-breaker session of the EASL meeting on Saturday, April 25, 2009.

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 R7227 at Roche) expected to enter Phase 2b in the summer 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.

Pegasys® and Copegus® are registered trademarks of Roche.