Phase II telaprevir data from Tibotec featured in oral presentation at AASLD
Cork, Ireland (October 31, 2009) –Tibotec announced today results of a new study (VX950-C208), which showed that sustained virologic response (SVR) was achieved in more than 80 percent of treatment-naïve patients with chronic genotype 1 hepatitis C virus (HCV) who took telaprevir, administered either every 8 hours or every 12 hours, in combination with standard of care. Telaprevir, an investigational STAT-C (Specifically Targeted Antiviral Therapy for hepatitis C), is being co-developed by Tibotec in collaboration with Vertex Pharmaceuticals. The study was presented today at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting).
In the phase II study, which enrolled 161 treatment-naïve genotype 1 patients, rates of SVR (defined as undetectable HCV RNA at 24 weeks after completion of treatment) ranged from 81 to 85 percent in patients treated with the every 8 hour telaprevir-based regimen, and 82 to 83 percent in patients treated with the every twelve hour regimen. Adverse events (AEs) were similar to those observed in other trials with telaprevir and were mainly haematologic (anaemia) and cutaneous (rash and pruritus) in nature.
For the vast majority of patients, these high SVR rates were obtained with only 24 weeks of total treatment (half the duration of current standard of care). Total duration of treatment was decided using a criteria based on treatment response. Subjects who achieved undetectable HCV RNA at week 4 (rapid virologic response or RVR) and maintained this through week 20, were allowed to stop all treatment at week 24. Only 18% of subjects were required to continue standard treatment up to week 48.
Approximately 180 million people worldwide are infected with HCV,1 the most common cause of liver transplant in Europe.2 People with HCV genotype 1 currently face treatment limitations, including a standard of care that cures just 40 to 50 percent of patients.3 Without effective treatment, HCV can lead to serious and fatal diseases of the liver, including liver cancer4.
“The data presented today show that a significant number of treatment-naïve genotype 1 HCV patients achieved sustained virologic response with telaprevir, in combination with standard of care,” said professor Patrick Marcellin from Hôpital Beaujon in Clichy, France. “Telaprevir, which directly targets the virus by aiming to block its replication, could allow shortening treatment duration and increasing cure rates in people with HCV, [compared to standard of care] offering a new approach to treating HCV.”
About Telaprevir C208 study in Treatment-Naïve Patients
The phase IIa, open-label, randomised study evaluated telaprevir administered every eight hours or every 12 hours in combination with standard of care Peg-IFN alfa-2a (Pegasys®) and ribavirin (Copegus®) or Peg-IFN alfa2b (PegIntron®) and ribavirin (Rebetol®) in treatment-naïve patients with chronic genotype 1 HCV infection.
The objective of the trial was to explore the efficacy, safety, tolerability, pharmacokinetics, and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg every eight hours or 1125 mg every 12 hours in combination with Pegasys and Copegus or PegIntron and Rebetol. A total of 161 subjects were randomised to the following groups:
A: Telaprevir 750 mg q8h with Pegasys/Copegus (Tq8h/Peg2-a) (n=40)
B: Telaprevir 750 mg q8h with PegIntron/Rebetol (Tq8h/Peg2-b) (n=42)
C: Telaprevir 1125 mg q12h with Pegasys/Copegus (Tq12h/Peg2-a) (n=40)
D: Telaprevir 1125 mg q12h with PegIntron/Rebetol (Tq12h/Peg2-b) (n=39)
All subjects received 12 weeks of telaprevir treatment in combination with standard therapy. At the end of Week 12, telaprevir dosing was completed and subjects continued on standard therapy only. Most subjects achieved Rapid Virological Response (RVR) (undetectable at week 4) and remained undetectable until week 20 and were allowed to stop all treatment at week 24. Only 18% of subjects were required to continue standard treatment up to week 48.
Following are the efficacy findings, as measured by sustained viral response rates (SVRs):
The pharmacokinetic/pharmacodynamic analysis showed that total exposure to telaprevir (measured as AUC24h) was similar across all groups.
AEs were similar to those observed in other trials with Telaprevir. Serious AEs leading to permanent treatment discontinuation of all drugs were mainly related to rash (3%, 4/161) and anemia (2%, 3/161).
“For too long, people with HCV have faced treatment limitations, necessitating a paradigm shift in HCV therapy,” said Roger Pomerantz, MD, President of Tibotec Research and Development. “Tibotec is proud to apply its expertise in virology to discover, develop and make available new therapies that target HCV in a different way.”
About Telaprevir
There are currently two fully enrolled, pivotal phase 3 clinical trials examining telaprevir in genotype 1 HCV-infected adults – REALIZE in treatment-experienced patients and ADVANCE in treatment-naïve patients. REALIZE is the only ongoing phase 3 study comparing the efficacy of a regimen containing a STAT-C to current standard of care in null responders, while ADVANCE is evaluating the potential for a 24-week duration of therapy in treatment-naïve HCV genotype 1 patients. A third phase 3 study, ILLUMINATE, also fully-enrolled, will provide additional data on telaprevir in treatment-naïve patients.
Tibotec has the right to develop and commercialise telaprevir in Europe, South America, the Middle East, Africa, India, Australia and New Zealand; Vertex will commercialise telaprevir in the U.S., Canada, and Mexico and has a collaboration with Mitsubishi for commercialization in the Far East.
About HCV
With an estimated 180 million people infected worldwide and three to four million people newly infected each year, HCV poses a significant burden on patients and society1. Chronic infection with HCV, a blood-borne infectious disease that affects the liver, can lead to liver cancer and other serious and fatal liver diseases, and is the most common cause of liver transplant in Europe2,4. The current standard of care for HCV patients, treatment with pegylated interferon combined with ribavirin, only cures 40 to 50 percent of genotype 1 patients5. The development of new therapies, particularly direct antivirals with different modes of action, will allow HCV patients to undergo a more effective treatment regimen3.
About Tibotec BVBA
Tibotec BVBA is a global pharmaceutical and research development company. The Company’s main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA and Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS and hepatitis C drugs, and anti-infectives for diseases of high unmet medical need.
Forward Looking Statement
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Tibotec BVBA’s and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Tibotec BVBA or Johnson & Johnson. Neither Tibotec BVBA nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.
# # #
References
1The World Health Organization (WHO). Hepatitis C [Online] 2009 [cited 2009 Oct 15]; Available from: http://www.who.int/vaccine_research/diseases/viral_cancers/en/index2.html.
2Roche B and Samuel D. Risk factors for hepatitis C recurrence after liver transplantation. Journal of Viral Hepatitis 2007;14:89-96.
3Manns M et al. The Way Forward in HCV Treatment—Finding the Right Path. Nature Reviews December 2007;6:991-1000.
4Centers for Disease Control and Prevention (CDC). The ABCs of Hepatitis [Online] [cited 2009 Oct 15]; Available from: www.cdc.gov/hepatitis. Sagir A, Heintges T, Akyazi Z, Oette M, Erhardt A, and Häussinger D, Relapse to prior therapy is the most important factor for the retreatment response in patients with chronic hepatitis C virus infection (University of Dusseldorf, September 2007), pg. 1, para. 1.
5Sagir A et al. Relapse to prior therapy is the most important factor for the retreatment response in patients with chronic hepatitis C virus infection. Liver Int 2007 Sep;27(7):954-9.
Phase II telaprevir data from Tibotec featured in oral presentation at AASLD
Cork, Ireland (October 31, 2009) –Tibotec announced today results of a new study (VX950-C208), which showed that sustained virologic response (SVR) was achieved in more than 80 percent of treatment-naïve patients with chronic genotype 1 hepatitis C virus (HCV) who took telaprevir, administered either every 8 hours or every 12 hours, in combination with standard of care. Telaprevir, an investigational STAT-C (Specifically Targeted Antiviral Therapy for hepatitis C), is being co-developed by Tibotec in collaboration with Vertex Pharmaceuticals. The study was presented today at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting).
In the phase II study, which enrolled 161 treatment-naïve genotype 1 patients, rates of SVR (defined as undetectable HCV RNA at 24 weeks after completion of treatment) ranged from 81 to 85 percent in patients treated with the every 8 hour telaprevir-based regimen, and 82 to 83 percent in patients treated with the every twelve hour regimen. Adverse events (AEs) were similar to those observed in other trials with telaprevir and were mainly haematologic (anaemia) and cutaneous (rash and pruritus) in nature.
For the vast majority of patients, these high SVR rates were obtained with only 24 weeks of total treatment (half the duration of current standard of care). Total duration of treatment was decided using a criteria based on treatment response. Subjects who achieved undetectable HCV RNA at week 4 (rapid virologic response or RVR) and maintained this through week 20, were allowed to stop all treatment at week 24. Only 18% of subjects were required to continue standard treatment up to week 48.
Approximately 180 million people worldwide are infected with HCV,1 the most common cause of liver transplant in Europe.2 People with HCV genotype 1 currently face treatment limitations, including a standard of care that cures just 40 to 50 percent of patients.3 Without effective treatment, HCV can lead to serious and fatal diseases of the liver, including liver cancer4.
“The data presented today show that a significant number of treatment-naïve genotype 1 HCV patients achieved sustained virologic response with telaprevir, in combination with standard of care,” said professor Patrick Marcellin from Hôpital Beaujon in Clichy, France. “Telaprevir, which directly targets the virus by aiming to block its replication, could allow shortening treatment duration and increasing cure rates in people with HCV, [compared to standard of care] offering a new approach to treating HCV.”
About Telaprevir C208 study in Treatment-Naïve Patients
The phase IIa, open-label, randomised study evaluated telaprevir administered every eight hours or every 12 hours in combination with standard of care Peg-IFN alfa-2a (Pegasys®) and ribavirin (Copegus®) or Peg-IFN alfa2b (PegIntron®) and ribavirin (Rebetol®) in treatment-naïve patients with chronic genotype 1 HCV infection.
The objective of the trial was to explore the efficacy, safety, tolerability, pharmacokinetics, and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg every eight hours or 1125 mg every 12 hours in combination with Pegasys and Copegus or PegIntron and Rebetol. A total of 161 subjects were randomised to the following groups:
A: Telaprevir 750 mg q8h with Pegasys/Copegus (Tq8h/Peg2-a) (n=40)
B: Telaprevir 750 mg q8h with PegIntron/Rebetol (Tq8h/Peg2-b) (n=42)
C: Telaprevir 1125 mg q12h with Pegasys/Copegus (Tq12h/Peg2-a) (n=40)
D: Telaprevir 1125 mg q12h with PegIntron/Rebetol (Tq12h/Peg2-b) (n=39)
All subjects received 12 weeks of telaprevir treatment in combination with standard therapy. At the end of Week 12, telaprevir dosing was completed and subjects continued on standard therapy only. Most subjects achieved Rapid Virological Response (RVR) (undetectable at week 4) and remained undetectable until week 20 and were allowed to stop all treatment at week 24. Only 18% of subjects were required to continue standard treatment up to week 48.
Following are the efficacy findings, as measured by sustained viral response rates (SVRs):
The pharmacokinetic/pharmacodynamic analysis showed that total exposure to telaprevir (measured as AUC24h) was similar across all groups.
AEs were similar to those observed in other trials with Telaprevir. Serious AEs leading to permanent treatment discontinuation of all drugs were mainly related to rash (3%, 4/161) and anemia (2%, 3/161).
“For too long, people with HCV have faced treatment limitations, necessitating a paradigm shift in HCV therapy,” said Roger Pomerantz, MD, President of Tibotec Research and Development. “Tibotec is proud to apply its expertise in virology to discover, develop and make available new therapies that target HCV in a different way.”
About Telaprevir
There are currently two fully enrolled, pivotal phase 3 clinical trials examining telaprevir in genotype 1 HCV-infected adults – REALIZE in treatment-experienced patients and ADVANCE in treatment-naïve patients. REALIZE is the only ongoing phase 3 study comparing the efficacy of a regimen containing a STAT-C to current standard of care in null responders, while ADVANCE is evaluating the potential for a 24-week duration of therapy in treatment-naïve HCV genotype 1 patients. A third phase 3 study, ILLUMINATE, also fully-enrolled, will provide additional data on telaprevir in treatment-naïve patients.
Tibotec has the right to develop and commercialise telaprevir in Europe, South America, the Middle East, Africa, India, Australia and New Zealand; Vertex will commercialise telaprevir in the U.S., Canada, and Mexico and has a collaboration with Mitsubishi for commercialization in the Far East.
About HCV
With an estimated 180 million people infected worldwide and three to four million people newly infected each year, HCV poses a significant burden on patients and society1. Chronic infection with HCV, a blood-borne infectious disease that affects the liver, can lead to liver cancer and other serious and fatal liver diseases, and is the most common cause of liver transplant in Europe2,4. The current standard of care for HCV patients, treatment with pegylated interferon combined with ribavirin, only cures 40 to 50 percent of genotype 1 patients5. The development of new therapies, particularly direct antivirals with different modes of action, will allow HCV patients to undergo a more effective treatment regimen3.
About Tibotec BVBA
Tibotec BVBA is a global pharmaceutical and research development company. The Company’s main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA and Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS and hepatitis C drugs, and anti-infectives for diseases of high unmet medical need.
Forward Looking Statement
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Tibotec BVBA’s and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Tibotec BVBA or Johnson & Johnson. Neither Tibotec BVBA nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.
# # #
References
1The World Health Organization (WHO). Hepatitis C [Online] 2009 [cited 2009 Oct 15]; Available from: http://www.who.int/vaccine_research/diseases/viral_cancers/en/index2.html.
2Roche B and Samuel D. Risk factors for hepatitis C recurrence after liver transplantation. Journal of Viral Hepatitis 2007;14:89-96.
3Manns M et al. The Way Forward in HCV Treatment—Finding the Right Path. Nature Reviews December 2007;6:991-1000.
4Centers for Disease Control and Prevention (CDC). The ABCs of Hepatitis [Online] [cited 2009 Oct 15]; Available from: www.cdc.gov/hepatitis. Sagir A, Heintges T, Akyazi Z, Oette M, Erhardt A, and Häussinger D, Relapse to prior therapy is the most important factor for the retreatment response in patients with chronic hepatitis C virus infection (University of Dusseldorf, September 2007), pg. 1, para. 1.
5Sagir A et al. Relapse to prior therapy is the most important factor for the retreatment response in patients with chronic hepatitis C virus infection. Liver Int 2007 Sep;27(7):954-9.