Boehringer Ingelheim's interferon-free hepatitis C treatment portfolio strengthened by promising Phase II data

  • High rate of virologic response in Phase II hepatitis C trial of a 12 week all-oral combination of Boehringer Ingelheim's faldaprevir* and deleobuvir* and Presidio's PPI-668* with and without ribavirini
  • All patients (17/17) who have completed treatment achieved undetectable levels of hepatitis C virus at the end of treatmentii
  • 13 of these patients have reached their 4-week post-treatment followup and all have undetectable hepatitis C virus (SVR4)iii

BURLINGTON, ON, Nov. 11, 2013 /CNW/ - Interim data presented recently show that all patients (13/13) who reached their 4-weeks post-treatment followup have undetectable levels of hepatitis C virus (SVR4) after completing a 12-week treatment  with faldaprevir*, deleobuvir*, PPI-668* and ribavirin.iv These data from Boehringer Ingelheim's ongoing Phase II collaborative trial with Presidio Pharmaceuticals were presented on Monday during the 'Late-Breaking Posters' session at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which took place in Washington, D.C. Additional data from the trial show 100 per cent of patients (12/12) treated with a ribavirin-free regimen had hepatitis C virus (HCV) levels below the lower level of quantification at 4 weeks after initiation of treatment.v Safety and tolerability appears to be better in this ribavirin-free treatment arm compared to those with ribavirin.vi

The ongoing Phase II trial features the 12-week regimen both with and without ribavirin in 36 genotype-1a infected patients, one of the more difficult-to-cure types of HCV. In addition, more than half of the patients in the study (20/36) had pre-existing HCV mutations. This includes the Q80K variant, which is common in genotype-1a infected patients and has been associated with reduced responses to some HCV protease inhibitors.vii, viii Notably, all 12 patients in the study with pre-existing Q80K mutations are responding well to treatment with the faldaprevir*-based interferon-free regimen.ix To date, all patients in the study have received at least 4 weeks of treatment and 97 per cent (35/36) achieved HCV levels below the lower limit of quantification at week 4.x One patient had an initial virologic response but then exhibited viral breakthrough and was discontinued after 5 weeks of treatment.xi Overall, adverse events (AE) in the study 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*.xii

An individualized approach to hepatitis C
The breadth of patients studied in Boehringer Ingelheim's HCV trial program reflects a population that physicians see in the clinic, including those with difficult types of HCV to cure.

"The nature of hepatitis C infection is that it can vary from patient to patient, depending upon viral genotype, stage of the disease, the presence of other infections, as well as other important individual factors," said Dr. Mark Levstik, associate professor of medicine, division of gastroenterology, London Health Sciences Centre. "Therefore, when considering a treatment approach for patients, it is important to factor in these differences and assess patients according to their individual needs."

For more information on the importance of an individualized approach to HCV, view the HCV Video Series: Individualised HCV.

Phase IIa Presidio collaboration trial results
The trial includes 36 treatment-naïve patients with genotype-1a HCV treated for 12 weeks with an all-oral regimen, with 24 weeks of post-treatment followup. The primary endpoint is viral cure 12 weeks after treatment completion (SVR12). There are three cohorts in this study:xiii

  • Cohort 1: faldaprevir* 120 mg once-daily (QD), PPI-668* 200mg QD and deleobuvir* 600mg twice-daily (BID) with ribavirin (n=12)
  • Cohort 2: faldaprevir* 120 mg QD, PPI-668* 200mg QD and deleobuvir* 400mg BID with ribavirin (n=12)
  • Cohort 3: faldaprevir* 120mg QD, PPI-668* 200mg QD and deleobuvir* 600 mg BID, without ribavirin (n=12)

Thirty-six patients in this study have reached week 4 of treatment, 17 patients have reached the end of treatment (12 weeks) and 13 patients have reached their 4 week post-treatment followup. Interim results show:xiv

  • 97 per cent of patients (35/36) achieved HCV levels below the lower limit of quantification at week 4
  • 100 per cent of patients (17/17) that completed the full course of treatment had undetectable HCV at the conclusion of treatment
  • 100 per cent of patients (13/13) that completed the full course of treatment achieved SVR4

To date there has been just one treatment failure due to viral breakthrough. One patient had an initial virologic response but then exhibited viral breakthrough and was discontinued after 5 weeks of treatment. Only one AE was rated as 'severe' and attributable to study drugs; one patient reported severe fatigue in week 11 and the event was resolved with no change in treatment.xv

About Boehringer Ingelheim in Hepatitis C Virus (HCV)
In partnership with the scientific community, our clinical trial program, HCVerso™, is rigorously designed to find answers to the challenges that HCV patients face, including those who are the most difficult to treat. The HCVerso™ program includes the pivotal STARTVerso™ and HCVerso™ clinical trial programs.

Faldaprevir*, also known as BI 201335, an investigational, oral protease inhibitor discovered in Canada is specifically designed to target viral replication in the liver. Boehringer Ingelheim is developing faldaprevir* as a core component of both interferon-based and interferon-free hepatitis C treatment regimens. The Phase III STARTVerso™ trial program, which includes treatment-naïve, treatment-experienced and HIV co-infected patients with hepatitis C virus, is nearly complete.

Deleobuvir* is an investigational non-nucleoside NS5B polymerase inhibitor to treat patients with genotype-1b hepatitis C virus. Phase III HCVerso® trials, investigating the interferon-free regimen of twice-daily deleobuvir* in combination with once-daily faldaprevir* and ribavirin, are well underway.

As part of Boehringer Ingelheim's long-term commitment to hepatitis C, the company is also evaluating other combinations of investigational hepatitis C compounds that work in different ways. Boehringer Ingelheim's recent collaboration with Presidio Pharmaceuticals, Inc. for a Phase II clinical study investigating an interferon-free, all-oral, potentially ribavirin-free combination is part of the company's continued exploration to discover and develop innovative options for the treatment of HCV.

About Hepatitis C
Hepatitis C is a leading cause of chronic liver disease, liver cancer and transplantation that affects approximately 170 million people globally.xvi In Canada, an estimated 240,000 individuals, with some estimates as high as 400,000 are infected with the disease.xvii The Canadian Liver Foundation estimates that since 2007 approximately 500 people die from hepatitis C-related illnesses in Canada each year.xviii The number of hepatitis C-associated illnesses, including cirrhosis, liver failure, liver death and the need for liver transplants will likely double or triple in the next decade.xix

Of patients with chronic hepatitis C, 20 per cent will develop liver cirrhosis, of which 2 to 5 per cent will die every year.xx

About Boehringer Ingelheim (Canada) Ltd.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees.

Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavours.

In 2011, Boehringer Ingelheim posted net sales of 13.2 billion euro while spending almost 24 per cent of net sales in its largest business segment Prescription Medicines on research and development.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 and is home to more than 750 employees across the country. For more information please visit www.boehringer-ingelheim.ca.

About Presidio in HCV
Presidio Pharmaceuticals, Inc. is a San Francisco-based clinical stage specialty pharmaceutical company focused on the discovery and development of oral pan-genotypic therapeutics for HCV patients. Efforts are currently focused on novel inhibitors of both the HCV NS5A and NS5B genes. PPI-668* is an investigational, pan-genotypic, once daily, NS5A inhibitor. In earlier clinical studies in healthy volunteers and HCV-infected patients, PPI-668* has been well tolerated to date with no serious or severe adverse events and no apparent pattern of treatment-related clinical side effects or laboratory abnormalities. PPI-668* achieves plasma concentrations high enough to inhibit most pre-existing resistant variants and achieves steady-state levels after a single dose. In a clinical study of PPI-668* monotherapy in GT1 HCV-infected patients, viral load reductions of 3.5 to 3.7 log10 HCV were achieved in 1 to 2 days. Activity was also noted in GT3 HCV-infected patients.

Presidio's NS5B inhibitor, PPI-383*, is a novel pan-genotypic non-nucleosidic inhibitor with potential to inhibit all of the major HCV genotypes. This compound is currently in Phase 1 studies in healthy subjects.  For more information, please visit our website at www.presidiopharma.com.

References
_____________

i Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting®, the  64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 - 5 November, 2013.
ii Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting®, the  64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 - 5 November, 2013.
iii Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting®, the  64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 - 5 November, 2013.
iv Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting®, the  64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 - 5 November, 2013.
v Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting®, the  64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 - 5 November, 2013.
vi Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting®, the  64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 - 5 November, 2013.
vii Wyles, D. L. Perspective: Beyond Telaprevir and Boceprevir: Resistance and New Agents for Hepatitis C Virus Infection. Drug Resistance in HCV 2012; 20(4):139-145.
viii FDA Antiviral Drugs Advisory Committee Meeting: Background Package for NDA 205123, Simeprevir (TMC435). 2013 http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371623.pdf [last accessed 24/10/2013].
ix Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting®, the  64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 - 5 November, 2013.
x Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting®, the  64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 - 5 November, 2013.
xi Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting®, the  64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 - 5 November, 2013.
xii Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting®, the  64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 - 5 November, 2013.
xiii Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting®, the  64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 - 5 November, 2013.
xiv Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting®, the  64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 - 5 November, 2013.
xv Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting®, the  64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 - 5 November, 2013.
xvi World Health Organisation. Hepatitis C. 2002 http://www.who.int/csr/disease/hepatitis/Hepc.pdf [Last accessed on 21/10/13].
xvii Sherman, M et al. Liver disease in Canada: A crisis in the making. Report by Canadian Liver Foundation. From web site. 2013.
xviii Sherman, M et al. Liver disease in Canada: A crisis in the making. Report by Canadian Liver Foundation. From web site.
xix Zou, S. et al. Epidemiology and Health Care Planning: Estimating the Burden of Hepatitis C in Canada. Health Canada.
xx Soriano, Vincent et al. New Therapies for Hepatitis C Virus Infection. Clinical Infectious Disease 2009; 48:313-20.

*Faldaprevir, deleobuvir and PPI668 are investigational compounds. Their safety and efficacy have not yet been fully established and they are not currently authorized for sale in Canada.

Video with caption: "Video: HCV Video Series: Individualised HCV". Video available at: http://stream1.newswire.ca/cgi-bin/playback.cgi?file=20131111_C6117_VIDEO_EN_33200.mp4&posterurl=http://photos.newswire.ca/images/20131111_C6117_PHOTO_EN_33200.jpg&clientName=Boehringer%20Ingelheim%20%28Canada%29%20Ltd%2E&caption=Video%3A%20HCV%20Video%20Series%3A%20Individualised%20HCV&title=BOEHRINGER%20INGELHEIM%20%28CANADA%29%20LTD%2E%20%2D%20Boehringer%20Ingelheim%27s%20interferon%2Dfree%20hepatitis%20C%20treatment%20portfolio%20strengthened%20by%20promising%20Phase%20II%20data&headline=Boehringer%20Ingelheim%27s%20interferon%2Dfree%20hepatitis%20C%20treatment%20portfolio%20strengthened%20by%20promising%20Phase%20II%20data

SOURCE: Boehringer Ingelheim (Canada) Ltd.

For further information:

Jennifer Mota
Brand Communication Associate
Boehringer Ingelheim (Canada) Ltd.
(905) 631-4739 (B)
(905) 484-1452 (C)
Email: jennifer.mota@boehringer-ingelheim.com

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