Tuesday, September 10, 2013

Boehringer Ingelheim broadens efforts for interferon-free hepatitis C treatments through clinical collaboration with Presidio Pharmaceuticals

Related: Boehringer Ingelheim HCV Drug Development Program

10 September 2013

Boehringer Ingelheim broadens efforts for interferon-free hepatitis C treatments through clinical collaboration with Presidio Pharmaceuticals

• First Phase IIa study includes Presidio’s PPI-668 in genotype-1a infected patients1; collaboration offers the potential to explore additional HCV genotypes in future trials
• Boehringer Ingelheim’s Phase III interferon-free HCVerso® trials in genotype-1b infected patients are fully enrolled; results are expected in Q2 20142,3

For media outside USA, UK and Canada only

INGELHEIM, 10 September 2013 – Boehringer Ingelheim today announced the completion of patient enrolment for a Phase IIa clinical trial investigating a new interferon-free, all-oral, direct-acting antiviral (DAA) combination treatment for patients with genotype-1a chronic hepatitis C virus (HCV) infection. The trial is conducted in collaboration with Presidio Pharmaceuticals, Inc. and evaluates Boehringer Ingelheim’s investigational compounds, the protease inhibitor faldaprevir+ and non-nucleoside NS5B polymerase inhibitor, deleobuvir+, in combination with Presidio’s pan-genotypic NS5A inhibitor, PPI-668, with and without ribavirin.1

The trial includes 36 treatment-naïve genotype-1a infected patients treated for 12 weeks with this all-oral DAA regimen, with 24 weeks of post-treatment follow-up. The primary endpoint of the trial is sustained virologic response 12 weeks after treatment is completed (SVR12).1 This Phase IIa trial of a novel combination therapy is part of Boehringer Ingelheim’s commitment to develop new, tailored interferon and potentially ribavirin-free HCV regimens for a broad range of HCV patients.

In March 2013, the two companies entered a non-exclusive collaboration to evaluate the three 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. Final results are expected in Q2 2014.1

Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim

"We are pleased to announce that enrolment is complete in this collaborative Phase IIa trial evaluating a new 12-week interferon-free treatment regimen. This regimen complements and expands our HCV portfolio with the goal of providing interferon-free treatments to patients with HCV," said Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim. "This study is the next step in our continued commitment to deliver effective and well-tolerated treatment options that are optimised for patients with different hepatitis C genotypes. The pan-genotypic properties of PPI-668 bear the potential to explore the efficacy of this regimen in a wider range of HCV genotypes in the future."

Eliminating injectable interferon from treatment is a critical goal in hepatitis C management.4 Clinical studies have shown that up to 50 percent of patients may not be eligible for treatment with interferon due to contraindications.5 Patients may also find interferon challenging due to the long treatment duration and side-effects. These side-effects commonly include fatigue, anxiety, depression, gastrointestinal and flu-like symptoms as well as more serious side-effects such as heart failure, sepsis, leukopenia, depression and vision loss.6,7

"Clinical trials evaluating multiple DAAs are exciting because they can help bring us closer to our goal of developing more effective and tolerable interferon-free and potentially ribavirin-free therapies," said Jacob Lalezari M.D., Director of Quest Clinical Research in San Francisco, CA. "By treating patients with multiple compounds that attack the hepatitis C virus in different ways, we hope to be able to cure more patients in less time with fewer of the side-effects associated with existing treatment options."

Boehringer Ingelheim has a comprehensive interferon-free clinical trial programme which includes three pivotal Phase III studies (HCVerso®). The HCVerso® studies include approximately 1,100 treatment-naïve HCV genotype-1b patients, including those who are interferon eligible or ineligible and patients with compensated liver cirrhosis.2,3

For more information regarding the trial, please visit www.clinicaltrials.gov.

1. ClinicalTrials.gov. Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
2. ClinicalTrials.gov. IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1. http://clinicaltrial.gov/ct2/show/NCT01732796?term=faldaprevir+bi+207127&rank=3 [Last accessed 17/04/13]
3. ClinicalTrials.gov. Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2. http://clinicaltrial.gov/ct2/show/NCT01728324?term=faldaprevir+bi+207127&rank=2 [Last accessed 17/04/13]
4. Jazwinski and Muir. Direct-Acting Antiviral Medications for Chronic Hepatitis C Virus Infection. October 2012.
5. Kramer JR. et al. Gaps In The Achievement Of Effectiveness Of HCV Treatment In National VA Practice. J Hepatology 2012; 56:320-5
6. National Institutes of Health; US Department of Health and Human Services. Chronic Hepatitis C: Current Disease Management. Bethesda, MD: National Institutes of Health; 2010. NIH Publication 10-4230 4
7. World Health Organization. Global Alert and Response: Hepatitis C Prevention and Treatment. http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index5.html
8. World Health Organisation. Hepatitis C. 2002 http://www.who.int/csr/disease/hepatitis/Hepc.pdf [Last accessed on 23/07/13]
9. Centers for Disease Control and Prevention (2012) Hepatitis C available at: HYPERLINK "http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseases-related-to-travel/hepatitis-c.htm" [Last accessed on 23/07/13]
10. World Health Organisation. Hepatitis C Fact Sheet. Updated July 2012 http://www.who.int/mediacentre/factsheets/fs164/en/index.html [Last accessed on 16/07/13]
11. Chen S.L., Morgan T.R. The Natural History of Hepatitis C Virus (HCV) Infection. Int J Med Sci 2006; 3:47-52. Available from http://www.medsci.org/v03p0047.htm [Last accessed on 16/07/13]
12. Soriano, Vincent et al. New Therapies for Hepatitis C Virus Infection. Clinical Infectious Disease, February 2009
13. ClinicalTrials.gov. Efficacy and Safety of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients. http://clinicaltrials.gov/ct2/show/NCT01343888?term=bi+201335&rank=4 [Last accessed 17/04/13]
14. ClinicalTrials.gov. BI 201335 Used in Treatment Naive Patients Infected With Genotype 1 Chronic Hepatitis C Infection. http://clinicaltrials.gov/ct2/show/NCT01297270?term=bi+201335&rank=5 [Last accessed 17/04/13]
15. ClinicalTrials.gov. Pivotal Trial Treatment Experienced Patient Infected With Hepatitis C Virus (HCV) Genotype 1 (GT1). http://clinicaltrials.gov/ct2/show/NCT01358864?term=bi+201335&rank=14 [Last accessed 17/04/13]
16. ClinicalTrials.gov. Phase III Trial of BI 201335 in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)- Human Immunodeficiency Virus (HIV) Coinfected Patients. http://clinicaltrials.gov/ct2/show/NCT01399619?term=bi+201335+HIV&rank=1 [Last accessed 17/04/13]
17. Lalezari, J. Et al. PPI-668, A Potent New Pan-Genotypic HCV NS5A Inhibitor: Phase 1 Efficacy and Safety. Poster Presented at 63rd Annual Mtg. of the American Association for the Study of Liver Diseases. November 2012


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