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Boehringer moves interferon-free hep C regimen into phase III

Oral combination drug achieved viral cure rate of up to 85 per cent in phase IIb

Boehringer Ingelheim headquarters

Boehringer Ingelheim will start registration trials of its interferon-free treatment regimen for hepatitis after encouraging results in a phase IIb study.

The combination of two of Boehringer's oral hepatitis C drugs - faldaprevir and BI 207127 - plus ribavirin achieved viral cure rate of up to 85 per cent after just 28 weeks' treatment in the SOUND-C2 trial, which included patients with advanced liver disease.

Faldaprevir is a once-daily protease inhibitor while BI 207127 is a non-nucleoside polymerase inhibitor. Ribavirin is a generic antiviral that has been used for years alongside injectable interferon alfa products as a mainstay treatment for hepatitis C.

If approved for marketing, Boehringer's all-oral regimen could be among the first treatment regimens to avoid the use of interferon alfa, which aside from its less convenient administration is also associated with severe side effects and is unsuitable for use in around half of all hepatitis C cases.

"We included a broad spectrum of patients in SOUND-C2, reflecting those that we see day-to-day in our clinics," commented the study's lead investigator Stefan Zeuzem of the Goethe University Hospital in Frankfurt, Germany.

He pointed out the trial included patients with cirrhosis, "who desperately need an effective alternative treatment option to interferon-based therapies".

The triple drug regimen was tested in 362 patients with mainly genotype-1b (GT-1b) hepatitis C, which is the most common variant seen around the world, with 9 per cent of those enrolled also suffering from cirrhosis.

Among the GT-1b group the cure rate for faldaprevir, BI 207127 and ribavirin was 85 per cent, although this dropped to 69 per cent when the entire patient cohort was assessed, according to the study investigators, who presented the data at the American Association for the Study of Liver Diseases (AASLD) annual meeting in Boston over the weekend.

Boehringer is vying with a number of other pharma companies to being the first interferon-free hepatitis C regimen to market, with analysts predicting multibillion-dollar sales for successful therapies.

Others include Bristol-Myers Squibb - which suffered a setback when it was forced to halt development of polymerase inhibitor BMS-986094 in August - as well as Merck & Co, Gilead Sciences and Abbott Laboratories.

Abbott presented positive results from a phase IIb trial of its protease inhibitor ABT-450, along with NS5a inhibitors ABT-267 and ABT-333, in patients who had failed standard interferon-based treatment, and said it intends to take the regimen into phase III testing.

Meanwhile, BMS presented positive phase II data on an all-oral combination of NS5A inhibitor daclatasvir, protease inhibitor asunaprevir and polymerase inhibitor BMS-791325.

12th November 2012

From: Research

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