Overview of preliminary results across the three studies of G/P:
|Study Name||Patient Population||Treatment Duration||Treatment Regimen||SVR 12 Rate|
|ENDURANCE-1||GT1 without cirrhosis, new to treatment ornot cured with previous IFN-basedtreatments (pegIFN +/- RBV or SOF/RBV +/-pegIFN), and patients co-infected with HIV-1||8 week||G/P||99% (n=348/351)|
|ENDURANCE-3||GT3 without cirrhosis,new to treatment||8 week||G/P||95% (n=149/157)|
|SURVEYOR-2(Part 4)||GT2, 4, 5, or 6 without cirrhosis, new totreatment or not cured with previous IFN-based treatments (pegIFN, SOF/RBV orpegIFN/SOF)||8 week||G/P||97% (n=196/203)|
AbbVie's clinical development program for (G/P) was designed to investigate a faster path to virologic cure for all major HCV genotypes (GT1-6), with the goal of addressing treatment areas of continued unmet medical need. Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR 12) are considered cured of hepatitis C.About the ENDURANCE and SURVEYOR Studies ENDURANCE-1, ENDURANCE-3 and SURVEYOR-2 (Part 4) are open-label, multi-center, registrational studies evaluating the safety and efficacy of G/P across all major chronic HCV genotypes (GT1-6). The primary efficacy endpoint for all studies is SVR 12. ENDURANCE-1 is a randomized study designed to evaluate the safety and efficacy of 8 and 12 week treatment durations of G/P in patients with GT1 chronic HCV infection without cirrhosis and new to treatment or not cured with previous IFN-based treatments (pegIFN +/- RBV or SOF/RBV +/- pegIFN), including patients co-infected with HIV-1. ENDURANCE-3 is a partially randomized study designed to evaluate the safety and efficacy of 8 and 12 week treatment durations of G/P in patients with GT3 chronic HCV infection without cirrhosis and new to treatment. The study has an additional active comparator arm of 12 weeks of sofosbuvir + daclatasvir (SOF+DCV). Additional data from study arms will be presented at an upcoming scientific congress. SURVEYOR-2 (Part 4) is a single-arm study evaluating 8 week treatment duration of G/P in patients with GT2, 4-6 chronic HCV infection without cirrhosis and new to treatment or not cured with previous IFN-based treatments (pegIFN, SOF/RBV or pegIFN/SOF). About Enanta Enanta Pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs for viral infections and liver diseases. Enanta's research and development efforts are currently focused on four disease targets: Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Non-alcoholic Steatohepatitis (NASH) and Respiratory Syncytial Virus (RSV).
Enanta has discovered novel protease inhibitors that are members of the direct-acting-antiviral (DAA) inhibitor classes designed for use against the hepatitis C virus (HCV). These protease inhibitors, developed through Enanta's collaboration with AbbVie, include paritaprevir, which is contained in AbbVie's marketed DAA regimens for HCV, and glecaprevir (ABT-493), Enanta's second protease inhibitor product, which AbbVie has developed in Phase 3 studies in a fixed-dose combination (G/P) with pibrentasvir (ABT-530), AbbVie's second NS5A inhibitor, and is preparing for regulatory approval filings in the U.S., Europe and Japan.Enanta has also discovered EDP-305, an FXR agonist product candidate for NASH, currently in Phase 1 clinical development, as well as a cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for HCV, which is also in Phase 1 clinical development. In addition, Enanta has early lead candidates for HBV and RSV in preclinical development. Please visit www.enanta.com for more information on our programs and pipeline. Forward Looking Statements Disclaimer This press release contains forward-looking statements, including statements with respect to the prospects for regulatory approval filings for AbbVie's investigational HCV treatment regimen containing glecaprevir (ABT-493). Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the efforts of AbbVie (our collaborator developing glecaprevir) to obtain regulatory approval of its glecaprevir/pibrentasvir(G/P) regimen containing glecaprevir and successfully commercialize it; the regulatory and marketing efforts of others with respect to competitive treatment regimens for HCV; regulatory and reimbursement actions affecting G/P, any competitive regimen, or both; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-K for the fiscal year ended September 30, 2015 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.