Potent synergy, activity and patient tolerance observed in Genotype 1 patients support development of Omega DUROS® continuous delivery therapy
WASHINGTON, DC, USA | May 21, 2007 | Intarcia Therapeutics, Inc., a privately held biopharmaceutical company, today announced the presentation of final results from a Phase 2 study comparing the combination of injectable omega interferon and ribavirin to omega interferon alone in treatment-naïve patients with genotype 1 chronic hepatitis C. The results demonstrate that omega interferon in combination with ribavirin is well tolerated and shows robust antiviral activity that is comparable to published data on the use of alpha interferon plus ribavirin in similar patient populations. The 72-week sustained viral response (SVR) data are being presented today at the Digestive Disease Week Conference in Washington, DC by Bruce R. Bacon, MD, Professor of Internal Medicine, Saint Louis University Medical Center, St. Louis, Missouri.
This Phase 2 study of daily subcutaneous omega interferon injections provides Intarcia with safety and clinical response data to support development of omega interferon delivered by continuous release from the DUROS® device.
"The safety and SVR rates achieved in this phase 2 study are encouraging in that they indicate that the combination of omega interferon and ribavirin may produce response rates which are similar to those achieved with alpha interferon and ribavirin in patients with HCV genotype-1”, said Dr. Bacon. “The positive results of this study allow us to proceed with the evaluation of continuous delivery of omega interferon delivered with the DUROS device. A trial evaluating dose response of the Omega DUROS device is expected to begin in the near future.”
The Phase 2 trial compared the safety and antiviral response of omega interferon alone with omega interferon in combination with ribavirin in 102 interferon-naïve patients in an open-label, multi-center, active-controlled study design. All study patients had genotype-1, the most treatment-resistant type of HCV, and the majority of patients (74%) had high baseline viral load (> 800,000 IU/ml), a well-established negative predictive factor for SVR. Patients received daily injections of omega interferon (25 mcg) for up to 48 weeks. The endpoints for this clinical trial were early viral response (EVR), defined as a 2-log reduction in HCV RNA after 12 weeks of treatment, and SVR, defined as undetectable HCV RNA 24 weeks after completion of 48 weeks of treatment. Response rates are presented in the table below:
HCV RNA Results
Omega IFN + RBV
N=67
Omega IFN Alone
N=35
Early Viral Response (EVR) p= 0.014
84%
60%
Sustained Viral Response (SVR) (LOD= 50 IU/ml) p= 0.001
36%
6%
With this study, Intarcia also took a step toward testing its hypothesis that approximating continuous drug levels through daily administration of omega interferon may minimize side effects when compared to current interferon therapies. This study demonstrates that omega interferon is well tolerated with only two discontinuations due to adverse events. Results of this Phase 2 study suggest a favorable overall safety profile with no substantial safety issues being identified. Normalization of serum ALT, a marker of reduced liver inflammation, occurred in 100% of patients achieving SVR; and no patients receiving omega interferon with ribavirin experienced relapse during 24 weeks of follow-up after completing 48 weeks of treatment.
Alice Leung, President and Chief Executive Officer of Intarcia stated, "We are excited about the Phase 2 injectable omega interferon combination therapy results presented by Dr. Bacon at the DDW conference. Based on the data so far, we believe that a continuous release formulation of omega interferon with the Omega DUROS device may improve the treatment of HCV by offering a more convenient, potentially safer and more efficacious therapy for HCV patients."
About Omega DUROS Therapy
Omega DUROS therapy is being developed to improve the treatment of HCV by offering a more convenient and potentially safer and more effective treatment. Omega DUROS therapy is designed to deliver a continuous and consistent dose of omega interferon for three months via the implantable DUROS device, a drug delivery technology developed by ALZA Corporation, and licensed to Intarcia for use in certain broad fields. Another product incorporating the DUROS technology has already been approved by the FDA for the palliative treatment of prostate cancer. Intarcia is also leveraging the DUROS technology in evaluating other drug development opportunities. The most advanced of these is focused on the delivery of GLP-1 and GLP-1 analogs with the DUROS device for the treatment of type 2 diabetes.
About Intarcia
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with chronic diseases in which there are significant unmet medical needs. Intarcia’s drug development expertise and competitive edge are complemented by its ability to stabilize macromolecules and to deliver them in a constant and consistent manner via the proprietary DUROS drug delivery platform. The initial programs that Intarcia is pursuing are in hepatitis C and type 2 diabetes.
About Hepatitis C
Hepatitis C is a major global public health problem. According to the World Health Organization, more than 170 million people worldwide are chronically infected with HCV, and three to four million new HCV infections occur annually. The U.S. Centers for Disease Control and Prevention has estimated that in the United States approximately 3.2 million people are chronically infected with HCV and approximately 25,000 new patients are infected each year. It is estimated that 10,000 to 12,000 patients die annually in the United States from complications resulting from HCV infection. The current standard of care for treating chronic hepatitis C is combination therapy consisting of pegylated alpha interferon and ribavirin.
About Diabetes
Diabetes affects more than 20 million in the United States and an estimated 194 million adults worldwide. Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States. According to the U.S. Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve target A1c levels with their current treatment regimen.
SOURCE: Intarcia Therapeutics, Inc.
Post Views: 122
Potent synergy, activity and patient tolerance observed in Genotype 1 patients support development of Omega DUROS® continuous delivery therapy
WASHINGTON, DC, USA | May 21, 2007 | Intarcia Therapeutics, Inc., a privately held biopharmaceutical company, today announced the presentation of final results from a Phase 2 study comparing the combination of injectable omega interferon and ribavirin to omega interferon alone in treatment-naïve patients with genotype 1 chronic hepatitis C. The results demonstrate that omega interferon in combination with ribavirin is well tolerated and shows robust antiviral activity that is comparable to published data on the use of alpha interferon plus ribavirin in similar patient populations. The 72-week sustained viral response (SVR) data are being presented today at the Digestive Disease Week Conference in Washington, DC by Bruce R. Bacon, MD, Professor of Internal Medicine, Saint Louis University Medical Center, St. Louis, Missouri.
This Phase 2 study of daily subcutaneous omega interferon injections provides Intarcia with safety and clinical response data to support development of omega interferon delivered by continuous release from the DUROS® device.
"The safety and SVR rates achieved in this phase 2 study are encouraging in that they indicate that the combination of omega interferon and ribavirin may produce response rates which are similar to those achieved with alpha interferon and ribavirin in patients with HCV genotype-1”, said Dr. Bacon. “The positive results of this study allow us to proceed with the evaluation of continuous delivery of omega interferon delivered with the DUROS device. A trial evaluating dose response of the Omega DUROS device is expected to begin in the near future.”
The Phase 2 trial compared the safety and antiviral response of omega interferon alone with omega interferon in combination with ribavirin in 102 interferon-naïve patients in an open-label, multi-center, active-controlled study design. All study patients had genotype-1, the most treatment-resistant type of HCV, and the majority of patients (74%) had high baseline viral load (> 800,000 IU/ml), a well-established negative predictive factor for SVR. Patients received daily injections of omega interferon (25 mcg) for up to 48 weeks. The endpoints for this clinical trial were early viral response (EVR), defined as a 2-log reduction in HCV RNA after 12 weeks of treatment, and SVR, defined as undetectable HCV RNA 24 weeks after completion of 48 weeks of treatment. Response rates are presented in the table below:
HCV RNA Results
Omega IFN + RBV
N=67
Omega IFN Alone
N=35
Early Viral Response (EVR) p= 0.014
84%
60%
Sustained Viral Response (SVR) (LOD= 50 IU/ml) p= 0.001
36%
6%
With this study, Intarcia also took a step toward testing its hypothesis that approximating continuous drug levels through daily administration of omega interferon may minimize side effects when compared to current interferon therapies. This study demonstrates that omega interferon is well tolerated with only two discontinuations due to adverse events. Results of this Phase 2 study suggest a favorable overall safety profile with no substantial safety issues being identified. Normalization of serum ALT, a marker of reduced liver inflammation, occurred in 100% of patients achieving SVR; and no patients receiving omega interferon with ribavirin experienced relapse during 24 weeks of follow-up after completing 48 weeks of treatment.
Alice Leung, President and Chief Executive Officer of Intarcia stated, "We are excited about the Phase 2 injectable omega interferon combination therapy results presented by Dr. Bacon at the DDW conference. Based on the data so far, we believe that a continuous release formulation of omega interferon with the Omega DUROS device may improve the treatment of HCV by offering a more convenient, potentially safer and more efficacious therapy for HCV patients."
About Omega DUROS Therapy
Omega DUROS therapy is being developed to improve the treatment of HCV by offering a more convenient and potentially safer and more effective treatment. Omega DUROS therapy is designed to deliver a continuous and consistent dose of omega interferon for three months via the implantable DUROS device, a drug delivery technology developed by ALZA Corporation, and licensed to Intarcia for use in certain broad fields. Another product incorporating the DUROS technology has already been approved by the FDA for the palliative treatment of prostate cancer. Intarcia is also leveraging the DUROS technology in evaluating other drug development opportunities. The most advanced of these is focused on the delivery of GLP-1 and GLP-1 analogs with the DUROS device for the treatment of type 2 diabetes.
About Intarcia
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with chronic diseases in which there are significant unmet medical needs. Intarcia’s drug development expertise and competitive edge are complemented by its ability to stabilize macromolecules and to deliver them in a constant and consistent manner via the proprietary DUROS drug delivery platform. The initial programs that Intarcia is pursuing are in hepatitis C and type 2 diabetes.
About Hepatitis C
Hepatitis C is a major global public health problem. According to the World Health Organization, more than 170 million people worldwide are chronically infected with HCV, and three to four million new HCV infections occur annually. The U.S. Centers for Disease Control and Prevention has estimated that in the United States approximately 3.2 million people are chronically infected with HCV and approximately 25,000 new patients are infected each year. It is estimated that 10,000 to 12,000 patients die annually in the United States from complications resulting from HCV infection. The current standard of care for treating chronic hepatitis C is combination therapy consisting of pegylated alpha interferon and ribavirin.
About Diabetes
Diabetes affects more than 20 million in the United States and an estimated 194 million adults worldwide. Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States. According to the U.S. Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve target A1c levels with their current treatment regimen.
SOURCE: Intarcia Therapeutics, Inc.
Post Views: 122
