Enanta Pharmaceuticals Announces Detailed Data from SAPPHIRE-I and SAPPHIRE-II Phase 3 Studies in Patients with Chronic Hepatitis C Virus Being Presented at the European Association for the Study of the Liver (EASL) Meeting
- SVR12 rates of 96% were demonstrated in both treatment-naïve and treatment-experienced genotype 1 (GT1) patients with chronic hepatitis C virus
- SVR12 rates of 95% to 100% were demonstrated in treatment-experienced GT1 patient sub-populations (SAPPHIRE-II)
The SAPPHIRE-I and SAPPHIRE-II studies report results from AbbVie’s investigational three direct-acting antiviral regimen containing ABT-450, Enanta’s lead protease inhibitor developed through Enanta’s collaboration with
In the SAPPHIRE-I (N=631) and SAPPHIRE-II (N=394) placebo-controlled studies, adult, non-cirrhotic patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection receiving the investigational three-direct-acting antiviral regimen with ribavirin (RBV) for 12 weeks achieved sustained virologic response rates 12 weeks post-treatment (SVR12) of 96.2 percent (n=455/473) and 96.3 percent (n=286/297), respectively.
In SAPPHIRE-II, treatment-experienced sub-populations randomized to the three direct-acting antiviral regimen with RBV in the study were prior null responders (49.2 percent), prior relapsers (29.0 percent) and prior partial responders (21.9 percent) to pegylated interferon and RBV.
SAPPHIRE-I and SAPPHIRE-II Results |
||||||||||
SAPPHIRE-I SVR12 (n=473) |
SAPPHIRE-II SVR12 (n=297) |
|||||||||
All GT1 | 96.2% (n=455/473) | 96.3% (n=286/297)* | ||||||||
GT1a | 95.3% (n=307/322) | 96.0% (n=166/173) | ||||||||
GT1b | 98.0% (n=148/151) | 96.7% (n=119/123) | ||||||||
Treatment-experienced (GT1a and GT1b) | ||||||||||
Prior null responders | n/a | 95.2% (n=139/146) | ||||||||
Prior relapsers | n/a | 95.3% (n=82/86) | ||||||||
Prior partial responders | n/a | 100.0% (n=65/65) | ||||||||
*Subgenotype could not be determined for one patient
In SAPPHIRE-I, high response rates were seen across patients with certain variable characteristics, including gender, race, body mass index, fibrosis stage and baseline HCV viral load, as some of these patients have historically had a reduced response to treatment.
Discontinuations due to adverse events were reported in 0.6 percent of patients in both arms in SAPPHIRE-I and in 1.0 percent of patients receiving the
About Study M11-646 (SAPPHIRE-I)
SAPPHIRE-I is a global, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with the three direct-acting antiviral regimen with RBV in non-cirrhotic, GT1a and GT1b HCV-infected adult patients new to therapy.
The study population consisted of 631 patients: 473 were randomized to the three direct-acting antiviral regimen with RBV for 12 weeks, and 158 patients were randomized to placebo for the initial 12 weeks. Patients initially randomized to placebo for the first 12 weeks then received open-label treatment with the
Of the 473 patients randomized to the three direct-acting antiviral regimen with RBV, one case (0.2 percent) of on-treatment virologic failure occurred and seven patients (1.5 percent) experienced post-treatment relapse. In addition, three patients (0.6 percent) were lost to follow-up and seven patients (1.5 percent) discontinued the study prematurely. Patients lost to follow-up were considered treatment failures.
About Study M13-098 (SAPPHIRE-II)
SAPPHIRE-II is a global, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with the three direct-acting antiviral regimen with RBV in non-cirrhotic, GT1a and GT1b HCV-infected, treatment-experienced adult patients who previously failed treatment with pegylated interferon and RBV.
The study population consisted of 394 patients: 297 were randomized to the three direct-acting antiviral regimen with RBV for 12 weeks, and 97 patients were randomized to placebo for the initial 12 weeks. Patients initially randomized to placebo for the first 12 weeks then received open-label treatment with the three direct-acting antiviral regimen with RBV for 12 weeks.
Of the 297 patients randomized to the three direct-acting antiviral regimen with RBV, there were no cases of on-treatment virologic failure and seven patients (2.4 percent) experienced post-treatment relapse. Of these patients, six were prior null responders and one was a prior relapser. Three patients (1.0 percent) prematurely discontinued therapy due to adverse events and one patient (0.3 percent) prematurely discontinued the study.
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 Disclaimers
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
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