Intarcia Therapeutics Announces Results From Phase 2 Study Of Injectable Omega Interferon Plus Ribavirin

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Phase 2 Study Of Omega Interferon

Intarcia Therapeutics Inc. announced final results from a Phase 2 study of omega interferon with or without ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C.

The results demonstrate that omega interferon in combination with ribavirin is well tolerated and show 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 42nd annual meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain by John McHutchison, MD, Associate Director, Duke Clinical Research Institute and Professor of Medicine, Duke University Medical Center, Durham, North Carolina.

This Phase 2 study of daily subcutaneous omega interferon injections provides Intarcia with safety and clinical response data to support continued development of omega interferon delivered by continuous release from the DUROS(R) device.

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"The safety and SVR rates achieved in this phase 2 study suggest that omega interferon plus ribavirin may achieve similar effects to alpha interferon and ribavirin in patients with HCV genotype-1," said Dr. McHutchison. "We look forward to results of the planned study of Omega DUROS therapy in which we will evaluate optimization of dose and pharmacokinetics through the delivery of omega interferon with the implantable DUROS device."

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 the end of 48 weeks of treatment.

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 patients."

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