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InterMune Announces Continuing Progress on HCV Protease Inhibitor ITMN-191 (R7227)
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- Principal Goals of Phase 1b MAD Trial Already Achieved - - Advancing to Triple Combination Trial -
BRISBANE, Calif., Jan 07, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- InterMune, Inc. (Nasdaq: ITMN) today provided an update on the progress of its Phase 1b multiple-ascending-dose (MAD) clinical trial evaluating ITMN-191 (R7227) as monotherapy in patients with chronic hepatitis C virus (HCV) infection. ITMN-191 is an HCV protease inhibitor in development by InterMune and its partner, Roche.
Dan Welch, President and Chief Executive Officer of InterMune, said, "We have now completed our first two dosage cohorts in the MAD study, with total daily doses of up to 300mg, and expect the third dosage cohort to be enrolled in January. We are very pleased to announce that after completing the first two low-dosage cohorts, we have already achieved the principal goals of the MAD study for viral kinetic performance, safety and tolerability and are now advancing the program to study ITMN-191 in combination with Pegasys(R) and ribavirin. In view of the very favorable safety profile observed to date, we will continue dose escalation in the MAD trial to a third and possibly fourth cohort in order to more fully evaluate the viral kinetic profile, safety and tolerability of higher doses of ITMN-191. In parallel with the conduct of the ongoing MAD study, we are preparing and will submit to the appropriate European authorities the clinical trial authorization application to gain approval to begin a 14-day triple combination study of ITMN-191 with Pegasys(R) and ribavirin in the second quarter."
The company also announced that it is on track to announce top-line viral kinetic and safety results from at least three treatment-naive dose cohorts of the ongoing MAD clinical study later in the first quarter of this year. InterMune also expects to submit full data from all available cohorts of the current Phase 1b study for possible presentation at one or more scientific conferences in the second quarter of 2008.
Phase 1b (MAD) Trial Design
The ongoing Phase 1b placebo-controlled study is designed to assess the effect of multiple doses of ITMN-191 given as monotherapy on viral kinetics, viral resistance, pharmacokinetics, safety and tolerability. The principal goal of the MAD study is to help choose the dose of ITMN-191 that when administered in combination with Pegasys(R) and ribavirin, would likely offer the most competitive protease inhibitor-based triple combination regimen in terms of efficacy, safety and tolerability.
In the Phase 1b study, three or four cohorts of treatment-naive patients receive ITMN-191 twice per day (BID) or three times per day (TID) with food for a period of 14 days. In addition, a single cohort of treatment-experienced chronic hepatitis C patients infected with HCV genotype 1 will be studied once the treatment-naive cohorts are completed.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a research and development portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in Phase 1b, a second-generation HCV protease inhibitor research program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com.
Pharmasset, InterMune Surge on Hepatitis C Trials
By Avram Goldstein
Jan. 7 (Bloomberg) -- Pharmasset Inc. and InterMune Inc., both working on hepatitis C treatments with Swiss drugmaker Roche Holding AG, soared in Nasdaq Stock Market trading after their medicines were found to be safe in testing.
Pharmasset, of Princeton, New Jersey, reported results of its hepatitis C drug R7128 after four weeks of treatment. Brisbane, California-based InterMune said it will test higher- dose levels and add participants to a study of its medicine, ITMN-191. Both drugs are being tested in combination with existing therapies, the companies said in statements today.
InterMune and Pharmasset are racing to develop new drugs to treat the incurable, liver-damaging disease, which has spread by blood-borne virus to about 180 million people, including more than 4 million in the U.S. The companies aim to make drugs that don't cause the debilitating side-effects, including anemia, that make existing products unattractive to many infected people.
``It's definitely a multibillion-dollar market,'' said Edward Nash, an analyst with Stifel Nicolaus & Co. in New York, in a telephone interview today. ``I call it the PlayStation 3 of biotech because every company wants to have a hepatitis C drug in development. It's one of the hotter, growing therapy areas.''
Estimating the value of the existing market is difficult, because it involves drugs like interferon, which can be used for several diseases, Nash said.
Shares Soar
Pharmasset jumped $6.25, or 45 percent, to $20.24 at 4 p.m. New York time in composite trading, the biggest gain since the company's initial public offering in April 2007. InterMune soared $5.05, or 38 percent, to $18.43. It was the biggest increase in eight years.
Pharmasset's R7128 left 85 percent of the chronically infected patients in the study with no trace of the hepatitis C virus. The company is studying the medicine in combination with two other Roche treatments, Pegasys and Copegus. The Basel, Switzerland, drugmaker agreed to collaborate on the treatment in October 2004.
InterMune's ITMN-191 is a type of antiviral medication known as a hepatitis C virus protease inhibitor, which is designed to block an enzyme that helps the virus reproduce. The company said it intends to start a 14-day trial of ITMN-191 with Pegasys and ribavirin, a standard treatment combination, in the second quarter if European authorities approve. The company said it will announce further results in this quarter.
In addition to Roche's Pegasys, Schering-Plough Corp. makes Peg-Intron, each taken in combination with generic ribavirin. Treatment lasts a year and can cause side effects including fever, fatigue and seizures. Many patients quit before they're cured, experts say.
``I think 2008 is going to be a very important year for getting more seminal data from the studies, with larger numbers of patients across multiple companies,'' Nash said.
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