Intarcia Therapeutics Announces Presentation of Final Results From a Phase 2 Combination Study for the Treatment of Hepatitis C at the Digestive Disease Week Conference Potent synergy, activity and patient tolerance observed in Genotype 1

patients support development of Omega DUROS(R) continuous delivery therapy



    WASHINGTON, May 21 /PRNewswire/ -- 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-naive 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.
     (Logo: http://www.newscom.com/cgi-bin/prnh/20050301/SFTU126LOGO)
     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(R) 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-naive 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        Omega IFN Alone
                                     N=67                   N=35
     Early Viral Response (EVR)      84 %                   60 %
     p= 0.014
     Sustained Viral Response
     (SVR) (LOD= 50 IU/ml)           36 %                    6 %
     p= 0.001
     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.
     DUROS is a registered trademark of ALZA Corporation (Mountain View, CA)
 licensed to Intarcia Therapeutics, Inc. Intarcia and its logo are
 trademarks of Intarcia Therapeutics, Inc. (Emeryville, CA).
 
 

SOURCE Intarcia Therapeutics, Inc.

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