Merck’s Investigational Chronic Hepatitis C Combination Therapy MK-5172/MK-8742 Demonstrates Antiviral Activity in Hard-to-Cure Patients with HCV Genotype 1 Infection

Clinical Findings Support Initiation of C-EDGE Phase 3 Program

Friday, April 11, 2014 1:00 am EDT

"These findings provide additional clinical evidence regarding the potential of MK-5172/MK-8742 in treating a broad spectrum of HCV patients."

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced interim results from the ongoing C-WORTHy study, a multi-arm Phase 2 clinical trial evaluating the efficacy and safety of an all-oral, once-daily regimen combining MK-5172, an investigational hepatitis C virus (HCV) NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor, among patients with chronic HCV Genotype 1 infection (GT1). Interim analysis of hard-to-cure¹ patients administered MK-5172/MK-8742 with and without ribavirin (RBV) for 12 or 18 weeks showed sustained viral response² (SVR), 4 to 8 weeks after the completion of therapy (SVR4/8):

• HCV GT1 infected, treatment-naïve cirrhotic patients, MK-5172/MK-8742 treated - 97 percent (28/29 and 29/30) for 12 and 18 weeks, and MK-5172/MK-8742 plus RBV - 90 percent (28/31) and 97 percent (30/31) for 12 and 18 weeks, respectively.
• HCV GT1 infected prior-null responder patients (with or without cirrhosis), MK-5172/MK-8742 treated - 91 percent (30/33) and 97 percent (29/30) for 12 and 18 weeks, respectively, and MK-5172/MK-8742 plus RBV treated 94 percent (30/32) and 100 percent (32/32) for the 12 and 18 weeks, respectively.
• Treatment-naïve, non-cirrhotic patients with HCV/HIV co-infection, MK-5172/MK-8742 treated for 12 weeks - 90 percent (26/29) and MK-5172/MK-8742 plus RBV for 12 weeks 97 percent (28/29).

These data were presented at the 49th Annual Meeting of the European Association for the Study of the Liver (EASL), also known as The International Liver Congress™ 2014 in London, UK.

“There is still a need for further options for the most difficult-to-cure patients, including those with cirrhosis and HCV/HIV co-infection,” said Dr. Eric Lawitz, MD, vice president, Scientific and Research Development, The Texas Liver Institute, and clinical professor of medicine, University of Texas Health Science Center in San Antonio. “These findings provide additional clinical evidence regarding the potential of MK-5172/MK-8742 in treating a broad spectrum of HCV patients.”

C-WORTHy Study Design

C-WORTHy is a randomized, dose-responsive, parallel-group, multiple-site, double-blind clinical trial comparing different patient populations exposed to different durations of treatment of MK-5172 (100 mg once daily) in combination with MK-8742 (50 mg once daily) with or without RBV in subjects with chronic HCV infection. A total of 471 patients with chronic HCV GT1 and HCV RNA levels of ≥10,000 IU/mL were enrolled in C-WORTHy and randomized across 16 arms. These results examine hard-to-cure subpopulations, including treatment-naïve patients with liver cirrhosis (12- and 18-week arms, with and without RBV), prior-null responder patients with and without cirrhosis (12- and 18-week arms, with and without RBV) and patients with HIV/HCV co-infection (12-week arms).

Key Findings for MK-5172/MK-8742

Viral suppression (HCV RNA levels less than 25 IU/mL) was demonstrated for treatment-naïve patients with cirrhosis, prior-null responder patients with and without cirrhosis and HIV/HCV co-infected patients by Treatment Week (TW)12. These levels were maintained at rates between 90 and 100 percent across patient subgroups through the completion of dosing and at the four-week treatment follow-up time point (FU4).

The most common adverse events observed among treatment-naïve patients with cirrhosis and prior-null responder patients with and without cirrhosis were fatigue (23% and 28%, respectively), headache (24% and 24%, respectively), and asthenia (8% and 19%, respectively). The most common adverse events observed among HIV co-infected patients were headache (8%), asthenia (8%), fatigue (7%), and sleep disorder (7%). There were no early discontinuations due to drug-related adverse events and no clinically significant abnormalities observed in routine laboratory analysis of hematologic markers.

About Merck’s Phase 3 HCV Program: C-EDGE

Based on the results of the Phase 2 clinical program, Merck has initiated Phase 3 clinical trials for MK-5172/MK-8742. The Phase 3 program, called C-EDGE, will evaluate the safety and efficacy of MK-5172/MK-8742 with and without ribavirin in various genotypes and across a broad range of patient populations with chronic HCV. Study cohorts will include: C-EDGE TN (GT1, GT4-6; treatment-naive ± cirrhosis), C-EDGE CO-INFXN (GT1, GT4-6; treatment-naive ± cirrhosis with HIV/HCV co-infection), C-EDGE RECOVERY (GT1, GT4-6; treatment-naive ± cirrhosis; ± HIV/HCV co-infection on opiate substitution therapy), and C-EDGE TE (GT1, GT4-6; prior failed treatment with peginterferon/ribavirin; ± HIV/HCV co-infection). Study information can be found at www.clinicaltrials.gov.

Merck’s Commitment to HCV

For more than 25 years, Merck has been at the forefront of the response to the HCV epidemic. Merck employees are dedicated to applying their scientific expertise, resources and global reach to deliver healthcare solutions that support people living with HCV worldwide.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside of the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2013 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

¹ Defined as treatment-naïve patients with liver cirrhosis, prior-null responder patients with and without cirrhosis and patients with HIV/HCV co-infection

² Defined as HCV RNA below the limit of quantification or below the limit of detection at the last visit on record – 4, 8, 12, or 24 weeks after the completion of therapy

Contact:

Merck

Media Contacts:

Caroline Lappetito, 267-305-7639

Sarra Herzog, 201-669-6570 or

Investor Contacts:

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Justin Holko, 908-423-5088

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Boehringer Ingelheim’s interferon-free hepatitis C treatment portfolio strengthened by promising interim Phase 2a data

November 02, 2013

Clinical trial studies an all-oral, 12-week regimen containing the investigational compounds faldaprevir, deleobuvir, and Presidio Pharmaceuticals’ PPI-668 with and without ribavirin in 36 difficult-to-treat genotype-1a HCV patients
All 13 patients who reached the 4-week post-treatment follow-up had undetectable hepatitis C virus (SVR 4)

For U.S. Media Only

Ridgefield, CT, November 2, 2013– Boehringer Ingelheim Pharmaceuticals, Inc. today announced interim data from its Phase 2a hepatitis C (HCV) clinical collaboration (NCT01859962) with Presidio Pharmaceuticals, Inc. that showed all patients (13/13) who reached the 4-week post-treatment follow-up had undetectable levels of hepatitis C virus (SVR4) with an investigational, 12-week, all-oral regimen of faldaprevir and deleobuvir, in combination with Presidio’s pan-genotypic NS5A inhibitor, PPI-668, with ribavirin. The primary efficacy endpoint of this ongoing trial is sustained virologic response 12 weeks after completion of treatment (SVR12).

An additional study arm evaluating the regimen without ribavirin, which was added per protocol following initial results in the ribavirin-containing arms, showed that after four weeks on treatment, 12/12 patients had hepatitis C virus levels below an amount that can be quantified (LLOQ).  

These data are being presented during the late-breaking poster session at the 64^th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place in Washington, D.C.

“We continue to be encouraged by the preliminary results of this investigational triple combination of direct-acting antivirals in patients with genotype-1a HCV, and in particular that, at this stage, the ribavirin-free combination has yielded similar results to the ribavirin-containing arms of the trial,” said Jacob Lalezari, M.D., director of Quest Clinical Research in San Francisco, CA.

This ongoing Phase 2a study evaluates 36 treatment-naïve genotype-1a HCV patients. Two thirds of patients have the difficult-to-treat CT or TT IL28B genotype. Previous studies have shown that presence of the CT and TT IL28B genotypes led to a reduced likelihood of achieving viral cure. In addition, more than half the patients in the study (20/36) have pre-existing HCV mutations. These include the Q80K variant in 12 of these patients, all of which had virologic responses to the faldaprevir-based triple direct-acting antiviral (DAA) regimen. Also in this trial, 19% of patients are African American.

“These results add to the growing body of data for HCV regimens containing our investigational compound, faldaprevir,” said Peter Piliero, M.D., vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “We are looking forward to the final results of this trial, as well as our other studies evaluating all-oral regimens, as researchers strive to make an interferon-free future a reality for a broad range of HCV patients.”

This study contains three arms:

• The first arm 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 arm 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 faldaprevir 120 mg QD, PPI-668 200mg QD and deleobuvir 600mg BID without ribavirin

All patients in the study have received at least 4 weeks of treatment and 97% (35/36) achieved LLOQ. To date, one patient who had pre-existing NS5A and NS5B mutations failed treatment. This patient had a partial response to treatment but developed viral breakthrough and was discontinued.

To date, there has been one treatment discontinuation due to adverse events. The patient self-discontinued at week 9 on treatment due to gastrointestinal side effects. This patient had undetectable levels of HCV RNA by day 10 of treatment. Overall, adverse events 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. Benign bilirubin elevation (unconjugated hyperbilirubinemia) has been common in the trial and has occurred in 88% of patients in ribavirin-containing arms, and 46% of patients in the ribavirin-free arm. In the ribavirin-free treatment arm, most adverse events (83%) have been characterized as mild. In the ribavirin-containing arms, adverse events have been mild to moderate.

In March 2013, Boehringer Ingelheim and Presidio Pharmaceuticals entered into 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.

Additional Boehringer Ingelheim Interferon-Free Data
Also at AASLD, data from Boehringer Ingelheim’s interferon-free Phase 2 clinical trial, SOUND-C3 (NCT01132313), are being presented. This study evaluated the investigational compounds, faldaprevir and deleobuvir, with ribavirin in treatment-naïve patients with genotype-1b HCV. The results of this study showed that 95% of patients achieved SVR12 after 16 weeks of treatment.

The SOUND-C3 trial was one of Boehringer Ingelheim’s first studies evaluating investigational faldaprevir without interferon, in combination with investigational deleobuvir and ribavirin. This study informed the company’s current interferon-free development program, including the ongoing clinical collaboration with Presidio Pharmaceuticals.

As part of Boehringer Ingelheim’s long-term commitment to an interferon-free future for patients with HCV, the company recently completed patient enrollment for its Phase 3 clinical trials, HCVerso^®1 and 2 (NCT01732796, NCT01728324), which investigate the efficacy and safety of the investigational compounds, faldaprevir and deleobuvir, in combination with ribavirin. These trials evaluate genotype-1b HCV patients, including difficult-to-treat populations such as those who are ineligible for interferon and those with liver disease including cirrhosis. 

Faldaprevir, deleobuvir, and PPI-668 are investigational compounds and not approved. Their safety and efficacy have not been fully established.

About Boehringer Ingelheim in Hepatitis C Virus (HCV)
In partnership with the scientific community, our clinical trial program is rigorously designed to find answers to the challenges that HCV patients face, including those who are the most difficult to treat. Our pivotal HCV clinical trials for faldaprevir and deleobuvir are comprised of two multi-trial programs, STARTVerso™ (NCT01343888, NCT01297270, NCT01358864, NCT01399619) and HCVerso^®.

Faldaprevir (BI 201335) is an investigational, oral protease inhibitor that 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. STARTVerso^™ is a multi-study Phase 3 trial program that evaluates faldaprevir combined with PegIFN/RBV. The four trials that make up this program study the combination in treatment-naïve, treatment-experienced and HIV/HCV coinfected patients with chronic genotype-1 HCV. Deleobuvir (BI 207127) is an investigational NS5B non-nucleoside polymerase inhibitor that has shown the potential to eliminate interferon from HCV treatment when combined in a regimen with faldaprevir and RBV. Phase 2 trials of this interferon-free regimen have been completed and Phase 3 HCVerso^® trials investigating this regimen are now underway. As part of our long-term commitment to HCV, the company is exploring other combinations of investigational HCV compounds that work in complementary ways. The recent collaboration of Boehringer Ingelheim with Presidio Pharmaceuticals, Inc. for a Phase 2a clinical study investigating an interferon- and ribavirin-free, all-oral combination is part of the company’s continued commitment to discover and develop innovative options for the treatment of HCV.

STARTVerso^™ and HCVerso^® are registered service marks of Boehringer Ingelheim International GmbH.

Hepatitis C is a blood-borne infectious disease and a leading cause of chronic liver disease, transplant and failure that affects as many as 150 million people globally. In the United States, approximately 3.2-5.2 million people have chronic HCV infection. Since 1999 there has been a significant increase in deaths due to chronic HCV, which accounts for 10,000 -12,000 deaths in the United States per year.

About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim’s culture. 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 endeavors.

For more information please visit www.us.boehringer-ingelheim.com.

About Presidio in Hepatitis C Virus (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 1-2 days. Activity was also noted in GT3a HCV-infected patients.

Presidio’s NS5B inhibitor, PPI-383, is a novel pan-genotypic non-nucleoside 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 www.presidiopharma.com.

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

Phase 3 data show viral cure rates achieved in a broad range of patients with genotype-1 hepatitis C taking investigational compound faldaprevir plus PegIFN/RBV

November 02, 2013

Multiple studies presented at The Liver Meeting^® investigating faldaprevir include difficult-to-cure patient populations, such as those with HIV/HCV coinfection and advanced liver disease

For U.S. Media Only

Ridgefield, CT, November 2, 2013– Boehringer Ingelheim Pharmaceuticals, Inc. today announced new data from its Phase 3 clinical trial program, STARTVerso™, which evaluates the investigational protease inhibitor, faldaprevir, in combination with pegylated interferon and ribavirin (PegIFN/RBV). The Phase 3 clinical program includes trials in treatment-naïve (STARTVerso™1&2 - NCT01343888, NCT01297270), treatment-experienced (STARTVerso™3 - NCT01358864), and HIV/HCV coinfected (STARTVerso™4 - NCT01399619)  patients with genotype-1 (GT1) hepatitis C (HCV).  The primary efficacy endpoint of all trials is viral cure 12 weeks after the conclusion of treatment (SVR12).

In a pooled analysis of treatment-naive, gentotype 1 patients (STARTVerso™1&2), 73% (382/521) and 72% (378/524) of all patients treated with 120mg or 240mg of faldaprevir once-daily, both in combination with PegIFN/RBV, respectively, achieved SVR12. In comparison, 50% (131/264) of patients treated with PegIFN/RBV alone achieved SVR12. Also in the pooled analysis, 84% (436/521) of patients who received a regimen including 120mg of faldaprevir once-daily were eligible for an overall shortened time on treatment of 12 weeks on faldaprevir and 24 weeks on PegIFN/RBV. Of these patients, 83% (362/436) achieved SVR12.

In treatment-experienced patients (STARTVerso™3), 12 weeks of faldaprevir-based treatment (240mg once-daily), in combination with PegIFN/RBV,demonstrated SVR12 of 70% (69/99) in patients who relapsed on previous HCV treatment, compared to 14% (7/49) of patients taking PegIFN/RBV alone. In patients who partially responded to previous treatment, 58% (33/57) achieved SVR12, compared to 3% (1/29) of patients taking PegIFN/RBV alone. In patients who showed no response to previous treatment, 33% (48/145) achieved SVR12.

Additionally, early sustained viral response rates in patients coinfected with HIV/HCV (STARTVerso™4) showed that 74% (229/308) of patients treated with a faldaprevir-based regimen (120mg or 240mg once-daily), in combination with PegIFN/RBV, had undetectable HCV at four weeks following treatment completion (SVR4). The study includes patients coinfected with HCV and HIV who were treatment-naïve or had relapsed after previous HCV therapy with PegIFN/RBV, and were either HIV treatment-naïve or being treated with ART.
The results from these and additional studies will be presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting^®, taking place November 1-5 in Washington, D.C.

“HCV patients have various treatment needs, and this data studying an interferon-based regimen may be particularly encouraging for those with advanced liver disease, including cirrhosis, who may need treatment urgently,” said Douglas Dieterich, M.D., professor of medicine in the Division of Liver Diseases, Mount Sinai School of Medicine.

More than 2,200 patients have been studied in the STARTVerso™ trial program, including a large proportion of patients with difficult-to-cure types of HCV:

• Over 300 patients in the STARTVerso™ program have HIV/HCV coinfection (STARTVerso™4); these patients are known to have lower response rates to treatment and are therefore considered difficult to cure. In this trial, 14% of patients are African American
• 677 patients in the STARTVerso™ program (STARTVerso™3) are treatment-experienced, meaning they had attempted previous HCV treatment but did not achieve viral cure
• 40% of patients in STARTVerso™3 (treatment-experienced patients) have advanced liver disease (≥F3 fibrosis)
• 59% of patients in STARTVerso™1&2 (treatment-naïve patients) have a non-CC IL28B genotype; in previous studies, these patients have been less likely to achieve viral cure

“These pivotal data from STARTVerso™ are important for Boehringer Ingelheim’s HCV portfolio as they support the filing of a New Drug Application for faldaprevir with the Food and Drug Administration,” said Peter Piliero, M.D., vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “These results take us a step closer towards our goal of making faldaprevir available for patients who urgently need HCV treatment.”

In the STARTVerso™ clinical trial program, adverse events (AEs) most commonly included nausea, fatigue, diarrhea, headache, anemia, weakness, rash and jaundice due to transient bilirubin elevation (unconjugated hyperbilirubinemia). In STARTVerso™1&2, anemia occurred in 14%, 13%, and 14% of patients taking 120mg and 240mg faldaprevir regimens or PegIFN/RBV alone, respectively. Hyperbilirubinemia occurred in 12% (120mg), 46% (240mg) and less than 1% (PegIFN/RBV) of patients, and was transient. ALT elevations in the faldaprevir arms were similar to placebo, and occurred in 2% (120mg), 2% (240mg) and 3% (PegIFN/RBV) of patients. Gastrointestinal side effects occurred in 11% (120mg), 18% (240mg) and 7% (PegIFN/RBV) of patients. Rash occurred in 7% (120mg), 10% (240mg) and 4% (PegIFN/RBV) of patients. There was no occurrence of photosensitivity in the faldaprevir 120mg arm, and a 1% occurrence in the 240mg arm. Bilirubin associated AEs occurred in 3% (120mg), 9% (240mg) and 1% (PegIFN/RBV) of patients. Further, AEs leading to the discontinuation of faldaprevir occurred in 1% (120mg) and 3% (240mg) of patients.

In STARTVerso™3, AEs of at least moderate intensity in the 12- and 24-week faldaprevir arms included gastrointestinal side effects, which occurred in 20% (12-week), 17% (24-week) and 6% (PegIFN/RBV alone) of patients. Anemia occurred in 10% of patients in both faldaprevir arms (12- and 24-week) and 5% of patients taking (PegIFN/RBV alone). Rash, photosensitivity, and jaundice occurred in ≤ 5% of faldaprevir patients (12- or 24-week arms). Further, AEs leading to the discontinuation of faldaprevir occurred in 7% (12-week) and 8% (24-week) of patients. In STARTVerso™4 to date, nausea has occurred in 28% and 44% of patients taking 120mg and 240mg faldaprevir regimens, respectively. Additionally, fatigue has occurred in 32% (120mg) and 35% (240mg) of patients, diarrhea has occurred in 25% (120mg) and 28% (240mg) of patients, headache has occurred in 24% (120mg) and 25% (240mg) of patients, asthenia has occurred in 26% (120mg) and 21% (240mg) of patients, and decreased appetite has occurred in 24% (120mg) and 20% (240mg) of patients. Thus far, discontinuation of faldaprevir due to AEs leading to the discontinuation of faldaprevir has occurred in 1% (120mg and 240mg) of patients. Serious AEs occurred in 14% (120mg) and 8% (240mg) of patients, resulting in one death from Stevens-Johnson syndrome (SJS) with onset 145 days after discontinuing treatment while on systematic antibiotics.

Additional Boehringer Ingelheim Data at the Meeting
Additional late breaking data from Boehringer Ingelheim’scollaborative interferon-free trial with Presidio Pharmaceuticals will be presented on Monday, November 4. This ongoing Phase 2a study evaluates a 12-week, all-oral regimen of Boehringer Ingelheim’s investigational compounds, faldaprevir and deleobuvir, in combination with Presidio’s investigational pan-genotypic NS5A inhibitor, PPI-668, with and without ribavirin.

Further, data from other Boehringer Ingelheim studies will be presented at AASLD. The aim of these studies is to better understand faldaprevir’s drug-drug interaction profile in patients who are taking birth control and common anti-addiction medications. Additionally, a study evaluating faldaprevir in patients who have renal impairment will also be presented. Studies have shown that there is a higher prevalence of chronic kidney disease, also known as renal impairment, in patients with HCV making it important to understand the activity of HCV treatments in this population.  

Faldaprevir and deleobuvir are investigational compounds and not approved by the FDA. Their safety and efficacy have not been established.

Abstracts from The Liver Meeting^® can be accessed on the AASLD website at www.aasld.org.

About Boehringer Ingelheim in Hepatitis C Virus (HCV)
In partnership with the scientific community, our clinical trial program is rigorously designed to find answers to the challenges that HCV patients face, including those who are the most difficult to cure. Our pivotal HCV clinical trials for faldaprevir and deleobuvir are comprised of two multi-trial programs, STARTVerso™ and HCVerso^®.

Faldaprevir is an investigational, oral protease inhibitor that 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. STARTVerso^™ is a multi-study Phase 3 trial program that evaluates faldaprevir combined with PegIFN/RBV. The four trials that make up this program study the combination in treatment-naïve, treatment-experienced and HIV/HCV coinfected patients with chronic genotype-1 HCV. Deleobuvir is an investigational NS5B non-nucleoside polymerase inhibitor that has shown the potential to eliminate interferon from HCV treatment when combined in a regimen with faldaprevir and RBV. Phase 2 trials of this interferon-free regimen have been completed and Phase 3 HCVerso^® trials investigating this regimen are now underway. As part of our long-term commitment to HCV, the company is exploring other combinations of investigational HCV compounds that work in complementary ways. The recent collaboration of Boehringer Ingelheim with Presidio Pharmaceuticals, Inc. for a Phase 2a clinical study investigating an interferon- and ribavirin-free, all-oral combination is part of the company’s continued commitment to discover and develop innovative options for the treatment of HCV.

STARTVerso^™ and HCVerso^® are registered service marks of Boehringer Ingelheim International GmbH.

The Liver Meeting^® is a registered trademark of the American Association for the Study of Liver Diseases (AASLD).

Hepatitis C is a blood-borne infectious disease and a leading cause of chronic liver disease, transplant and failure that affects as many as 150 million people globally. In the United States, approximately 3.2-5.2 million people have chronic HCV infection. Since 1999 there has been a significant increase in deaths due to chronic HCV, which accounts for 10,000 -12,000 deaths in the United States per year.

About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim’s culture. 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 endeavors.

For more information please visit www.us.boehringer-ingelheim.com.

Source

Also See: Phase III data show Boehringer Ingelheim's faldaprevir* was highly effective in a broad range of patients with genotype-1 hepatitis C