Boehringer begins late-stage hep C trial
pharmafile | April 27, 2011 | News story | Research and Development | BI 201335, Boehringer Ingelheim, hepatitis C
Boehringer Ingelheim has begun enrolling patients in North America for a phase III trial of its chronic hepatitis C virus (HCV) candidate, which already has fast track designation from US regulators.
BI 201335 is an oral protease inhibitor and will be tested with standard-of-care in both treatment-naive and treatment -experienced patients with chronic genotype-1 HCV.
Boehringer says this is the most challenging HCV genotype to treat, and expects results from the studies in the first half of 2013. The primary endpoint is sustained viral response, which is considered viral cure.
Current standard treatment of HCV is pegylated interferon and ribavirin, but only 40-50% of patients see the virus suppressed to levels where they are considered to be cured.
“We look forward to initiating additional trials later this year in more patient populations, including HCV-HIV co-infected patients, as we continue to advance our HCV portfolio,” said Peter Piliero, Boehringer’s executive director of medical affairs.
Three phase III trials are currently signing up 1,875 participants worldwide.
In the US, Canada, Taiwan and Korea, study 1220.47 will look at treatment-naive patients at 95 sites, dosing BI 201335 once-daily at either 120mg or 240mg for 12 or 24 weeks in combination with 24 or 48 weeks of pegylated interferon and ribavirin.
Meanwhile, 1220.7 will study patients who have failed at least 12 weeks of standard treatment. BI 201335 will be dosed once-daily at 240mg for 12 or 24 weeks in combination with standard for 48 weeks for prior partial and null responder patients.
Patients with prior relapse will be dosed once-daily at 240mg for 12 or 24 weeks in combination with standard for 24 or 48 weeks in total.
Other new hepatitis C virus treatments
HCV is an increasingly crowded therapy area, with Merck’s new oral drug boceprevir given fast-track reviews from both the FDA and the European Medicines Agency after regulators decided it marked a major advance in treatment.
It may be launched in both the US and European market by July, with Johnson & Johnson’s rival treatment telaprevir also fast-tracked by the EMA and expected to reach the European market at the same time.
When added to standard therapy, telaprevir has raised cure rates from 44% to 75% by 24 weeks – half the time taken by pegylated interferon and ribavirin and some financial analysts have predicted peak sales for J&J’s drug of over $3 billion.
Earlier this year the company also began late stage trials of another hepatitis C drug, TMC435, as a first line treatment for the virus.
Adam Hill
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