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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

ive 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 c
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