Enanta Pharmaceuticals Announces Detailed Data from TURQUOISE-II Study in Chronic Hepatitis C Patients with Cirrhosis being Presented at the European Association for the Study of the Liver (EASL) Meeting
- In patients with compensated liver cirrhosis and genotype 1 (GT1) chronic hepatitis C virus, TURQUOISE-II demonstrated SVR12 rates of 91.8% and 95.9% after 12 and 24 weeks of treatment, respectively
- TURQUOISE-II is the largest phase 3, all-oral, Interferon-free study in cirrhotic patients with hepatitis C virus conducted to date
The TURQUOISE-II study reports results from AbbVie’s investigational three direct-acting antiviral regimen containing ABT-450, Enanta’s lead protease inhibitor discovered through Enanta’s collaboration with
TURQUOISE-II is a global, multi-center, randomized, open-label study evaluating the efficacy and safety of 12 weeks or 24 weeks of treatment with
TURQUOISE-II Results |
|||||||||||
12-Week Arm SVR12 (n=208) |
24-Week Arm SVR12 (n=172) |
||||||||||
All GT1 | 91.8% (n=191/208) | 95.9% (n=165/172) | |||||||||
GT1a | 88.6% (n=124/140) | 94.2% (n=114/121) | |||||||||
New to therapy | 92.2% (n=59/64) | 92.9% (n=52/56) | |||||||||
GT1a treatment-experienced | |||||||||||
Prior null responders | 80.0% (n= 40/50) | 92.9% (n=39/42) | |||||||||
Prior relapsers | 93.3% (n= 14/15) | 100.0% (n=13/13) | |||||||||
Prior partial responders | 100.0% (n= 11/11) | 100.0% (n=10/10) | |||||||||
GT1b | 98.5% (n=67/68) | 100.0% (n=51/51) | |||||||||
New to therapy | 100.0% (n= 22/22) | 100.0% (n=18/18) | |||||||||
GT1b treatment-experienced | |||||||||||
Prior null responders |
100.0% (n=14/14) |
100.0% (n=10/10) | |||||||||
Prior relapsers | 100.0% (n=25/25) | 100.0% (n=20/20) | |||||||||
Prior partial responders | 85.7% (n= 6/7) | 100.0% (n=3/3) | |||||||||
Discontinuation rates due to adverse events were 1.9 percent (four patients) and 2.3 percent (four patients) in the 12-week and 24-week arms, respectively. The most commonly reported adverse events (>10 percent in either arm) in TURQUOISE-II were fatigue, headache, nausea, pruritus, insomnia, diarrhea, asthenia, rash, cough, irritability, anemia and dyspnea.
On-treatment virologic failure occurred in one patient (0.5 percent) in the 12-week arm and three patients (1.7 percent) in the 24-week arm. In addition, 12 patients (5.9 percent) in the 12-week arm and one patient (0.6 percent) in the 24-week arm experienced relapse within 12 weeks post-treatment.
“Data presented to date from AbbVie’s three direct-acting antiviral regimen with and without ribavirin have demonstrated high SVR rates across a range of GT1 patient populations,” said
Additional results from studies using AbbVie’s three-direct-acting antiviral regimen containing ABT-450 being presented at the ILC today include:
- PEARL-III late-breaker poster: A phase 3 study examining the regimen for 12 weeks with or without RBV in non-cirrhotic GT1b HCV-infected adult patients who were new to therapy.
- M12-999 oral presentation: Interim results of a phase II examining the regimen with RBV for 24 weeks in non-cirrhotic liver transplant recipients with recurrent GT1 HCV infection
Additional information about AbbVie’s phase III studies can be found on www.clinicaltrials.gov.
About ABT-450
ABT-450 is an NS3 protease inhibitor discovered through Enanta’s collaboration with
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. Patients with compensated cirrhosis have a liver that is heavily scarred but that can still perform many important bodily functions with few or no symptoms. There is an acute need for new HCV therapies that are safer and more effective for many variants of the virus.
About Enanta
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including statements with respect to the prospects for AbbVie’s HCV treatment regimen containing ABT-450 that is being developed as a potential treatment across a range of GT1 patient populations. 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 the efforts of
Source:
Investor Contact
Enanta Pharmaceuticals, Inc.
Carol Miceli, 617-607-0710
cmiceli@enanta.com
or
Media Contact
MacDougall Biomedical Communications
Kari Watson, 781-235-3060
kwatson@macbiocom.com
- Print Page Print Page
- Email Alerts Email Alerts
- RSS Feeds RSS Feeds
- Contact IR Contact IR