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Investigational interferon-free regimen demonstrates undetectable hepatitis C virus in all patients reaching end of treatment in ongoing Phase II trial

October 8, 2013 - Ingelheim, Germany

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Boehringer Ingelheim today announced that interim data from its Phase II hepatitis C (HCV) clinical collaboration with Presidio Pharmaceuticals have been accepted for presentation as a late breaker poster at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place 1-5 November in Washington, D.C.1 The poster presentation will be on Monday 4 November.

This ongoing study evaluates a new 12-week interferon-free regimen of Boehringer Ingelheim’s protease inhibitor, faldaprevir*, and non-nucleoside NS5B polymerase inhibitor, deleobuvir*, in combination with Presidio’s pan-genotypic HCV NS5A inhibitor, PPI-668*, with and without ribavirin.1,2 The trial is fully enrolled (36 patients) and to date, 97% of patients (28/29) have achieved undetectable levels of virus at week 4 of treatment, also known as rapid viral response (RVR). Additionally, 100% of patients who have completed treatment (13/13) achieved undetectable levels of virus at the end of treatment.

“These results are promising particularly because they show the potential to evaluate harder-to-treat populations; all patients studied were genotype-1a and the majority of patients had the non-CC IL28B genotype,” said Jacob Lalezari, M.D., Director of Quest Clinical Research in San Francisco, CA.

Two thirds of patients in the study have the difficult-to-cure non-CC IL28B genotype1; previous studies have shown that presence of this genotype led to a reduced likelihood of achieving viral cure.3 In addition, of the 29 patients who have completed 4 weeks treatment, 11 had HCV NS5A and/or NS5B resistance substitutions which are mutations in the hepatitis C virus that can impact treatment response with some antiviral therapies.1 Ten of these patients achieved RVR and one patient had a partial response to treatment but developed viral breakthrough and was discontinued.

“This collaboration is part of our ongoing commitment to develop interferon-free treatment options for a broad range of real-world patients, including the difficult-to-cure who currently have few treatment options,” said Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim. “This data adds to the growing body of evidence for faldaprevir* which is the foundation of both, our interferon-based and interferon-free treatment regimens. We are encouraged by the data so far and look forward to further results at AASLD next month and the final results in Q2 2014.”

To date, there have been no treatment discontinuations for adverse events in this study. Adverse events overall have been mild to moderate, with the incidence and severity of skin rashes and gastrointestinal side effects similar to those observed in previous trials studying faldaprevir* and deleobuvir*.1

In March 2013, Boehringer Ingelheim and Presidio Pharmaceuticals entered a non-exclusive collaboration to evaluate the three direct acting antivirals (DAAs) in combination regimens. Both companies will retain all rights to their respective compounds. Presidio has operational responsibility for this collaborative trial, with oversight by an intercompany project team. Post-treatment sustained response data will be presented at the AASLD Congress next month and final results are expected in Q2 2014.

As part of the company’s long-term commitment to developing new therapeutic options for patients with HCV, Boehringer Ingelheim recently completed enrolment for its pivotal Phase III interferon-free HCVerso™ 1 and 2 trials. The trials are evaluating the treatment regimen of faldaprevir*, deleobuvir* and ribavirin in genotype-1b infected patients.

*Faldaprevir, deleobuvir and PPI668 are investigational compounds and not yet approved. Their safety and efficacy have not yet been fully established.

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About the Phase IIa Presidio collaboration trial

The trial includes 36 treatment-naïve patients with genotype-1a HCV treated for 12 weeks with an all-oral DAA regimen, with 24 weeks of post-treatment follow-up. There are three arms in this study:2

  • The first enrolled 12 patients and is evaluating faldaprevir* 120 mg once-daily (QD), PPI-668 200mg once-daily (QD) and deleobuvir* 600mg twice-daily (BID) with ribavirin
  • The second enrolled 12 patients and is evaluating faldaprevir* 120 mg QD, PPI-668 200mg QD and deleobuvir* 400mg BID with ribavirin
  • The third arm enrolled 12 patients and is evaluating the same regimen as arm 1, but without ribavirin

The primary endpoint of the trial is viral cure 12 weeks after treatment completion (SVR12).2

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Source: Business Wire India


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