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|Enanta Announces New Data From Phase 2b Interferon-Free Combination Studies with Protease Inhibitor ABT-450 for Hepatitis C Treatment to be Presented at EASL|
- Poster Presentations to Include Enanta’s Cyclophilin Inhibitor Program and Additional ABT-450 Data -
Results from "Aviator," AbbVie’s Phase 2b clinical trial of ABT-450 combined with two of AbbVie’s proprietary investigational direct-acting antivirals (DAAs), for the treatment of hepatitis C virus (HCV) infection, continue to demonstrate high sustained viral response (SVR) rates against genotype 1 HCV, across patient types. SVR rates of 96% to 99% after 12 weeks of treatment were achieved in patients new to treatment (naïve) and 93% in patients who had previously failed treatment with pegylated interferon and ribavirin (null responders). In addition, similarly high SVR rates over 90% observed after 24 weeks of treatment in the Phase 2b trial reinforce the adequacy of the 12-week treatment duration for the investigational interferon-free, triple DAA combination. The triple-DAA combination is currently being studied in Phase 3 clinical trials. Data from the "Aviator" study will be presented during the official ILC press conference in
About Study M11-652 (Aviator)
The objective of this Phase 2b study was to assess the safety, and efficacy of ABT-450/r (dosed 100/100 to 200/100mg once daily), ABT-267 (25mg once daily), ABT-333 (400mg twice daily) and ribavirin in non-cirrhotic, treatment-naïve patients and prior peg-interferon/ribavirin null responders administered for 8, 12 or 24 weeks. Enrollment was open to GT1-infected patients regardless of IL28B host genotype, and ribavirin dosing was weight-based.
A summary of key data from the trial is below:
For the 12-week triple-DAA regimen with ribavirin that is being studied in the Phase 3 trials, these Phase 2b Aviator data show:
With the triple-DAA plus ribavirin regimen, comparable SVR24 response rates were also seen in treatment naïve patients and null responder patients across HCV subtype, IL28B genotype, baseline HCV-RNA levels and severity of fibrosis.
SVR24 by patient subtype in the "Aviator" study
*The fibrosis analysis was post-hoc based on biopsy or non-invasive testing at screening.
The safety profile seen in this study is consistent with the initial presentation of results in
"Results from treatment utilizing ABT-450 in combination with other antiviral agents in AbbVie’s portfolio continue to generate high SVR rates across multiple HCV patient types," stated
The focus of ABT-450 development is to study the compound in combination with other antiviral agents in AbbVie’s portfolio. The three direct acting antivirals, or triple DAA cocktail, studied in the Phase 2b interferon-free Aviator trial included ritonavir-boosted protease inhibitor ABT-450/r, non-nucleoside polymerase inhibitor ABT-333, and NS5A inhibitor ABT-267.
Abstracts for the three presentations can be viewed at the EASL website at www.easl.eu
ABT-450 containing data presentations are as follows:
Enanta’s proprietary cyclophilin inhibitor data presentation:
"We continue to advance our lead cyclophilin candidates in preclinical studies and are continuing to generate and characterize a number of additional candidates," commented Yat Sun Or, Ph.D., Senior Vice President and Chief Scientific Officer. "We expect to select a preclinical candidate to advance during 2013."
About Hepatitis C Virus (HCV)
Hepatitis C is a liver disease affecting over 170 million people worldwide. The virus is typically spread through direct contact with the blood of an infected person. Hepatitis C increases a person’s risk of developing chronic liver disease, cirrhosis, liver cancer and death. There is an acute need for new HCV therapies that are safer and more effective for many variants of the virus.
Forward Looking Statement
This press release contains forward-looking statements, including with respect to our expectation that we will select a preclinical cyclophilin inhibitor candidate to advance to clinical trials during 2013 and expectations regarding the successful completion of clinical development of ABT-450. Statements that are not historical facts are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our 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 that may affect actual results include our ability to successfully identify appropriate candidates for clinical development of our future product candidates, the development efforts of our collaborators, regulatory actions affecting clinical development and clinical development of competitive product candidates. 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.