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Intarcia Therapeutics Announces Final Results From a Phase 2 Study,of Injectable Omega Interferon plus Ribavirin for the Treatment of,Hepatitis C Genotype-1

-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 the end of 48 weeks of treatment. Response rates are presented in the table below:


         HCV RNA Results               Omega IFN + RBV   Omega IFN Alone


    (LOQ= 50 IU/ml)                          N=67              N=35


    Early Viral Response (EVR)               84%               60%

    p= 0.014


    Sustained Viral Response(SVR)            36%               6%

    p= 0.001


With this study, Intarcia also took a step toward testing its hypothesis that maintaining continuous drug levels through daily administration of omega interferon may minimize side effects when compared to current interferon therapies. This study to date has shown 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 developing omega interferon to improve the treatment of HCV by offering a more convenient, potentially safer and more efficacious therapy. Based on the data so far, we believe that a continuous release formulation of omega interferon has the potential to become an important therapy for HCV pat
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