Enanta Announces New Data from AbbVie’s SURVEYOR-1 and SURVEYOR-2 Studies Showing High Sustained Virologic Response Rates after 8 or 12 Weeks of Treatment in Patients with any of Genotypes 1 through 6 of Hepatitis C Virus
- 97-98 percent SVR12 achieved with eight weeks of ABT-493 and ABT-530 treatment in genotypes 1, 2 or 3 HCV patients without cirrhosis in SURVEYOR 1 and 2 studies1,2
- 100 percent SVR12 achieved with 12 weeks of treatment in difficult-to-treat genotype 3 patients with compensated cirrhosis (Child-Pugh A) new to therapy 3
- 100 percent SVR12 achieved with 12 weeks of treatment in genotypes 4, 5 or 6 patients without cirrhosiss; eight-week treatment duration being investigated in this ongoing study4
- ABT-493 is Enanta’s second protease inhibitor being developed in combination with ABT-530, AbbVie’s NS5A inhibitor
In separate late-breaking data from the SURVEYOR-2 study, 100 percent of GT3 chronic HCV infected patients with compensated cirrhosis (Child-Pugh A) and new to therapy achieved SVR12 with 12 weeks of treatment with or without RBV (n=24/24 in each arm).3 No patients discontinued treatment due to adverse events. Data in GT3 chronic HCV infected patients with or without cirrhosis were featured in the official ILC 2016 press program.
ABT-493 is Enanta’s second protease inhibitor being developed through its collaboration with
“We are pleased that this ABT-493-containing regimen is demonstrating high sustained virologic response rates across multiple genotypes and without ribavirin,” commented
In a pooled analysis of 531 patients across both SURVEYOR studies of the five treatment regimens of ABT-493 and ABT-530 evaluated, the most commonly reported adverse events were fatigue (18 percent), headache (17 percent), nausea (13 percent) and diarrhea (10 percent).5 Three patients across all study arms evaluated to date, two of whom received RBV, discontinued study drugs early due to adverse events.5
Overview of SURVEYOR-1 and SURVEYOR-2 Clinical Data Presented at ILC: |
||||||||
Patient |
Patient number (n)/
|
Duration of |
Treatment |
SVR12 Rates
|
||||
GT1
Non-cirrhotic1
SURVEYOR-1 |
n=34 Treatment-naïve=85%
pegIFN/RBV treatment |
8 weeks |
ABT-493 (300mg) + |
97%
(n=33/34) |
||||
GT2
Non-cirrhotic1
SURVEYOR-2 |
n=54 Treatment-naïve=87%
pegIFN/RBV treatment
experienced=13%
|
8 weeks |
ABT-493 (300mg) + |
98%
|
||||
GT3
Non-cirrhotic2
SURVEYOR-2 |
n=29
|
8 weeks |
ABT-493 (300mg) + |
97%
|
||||
GT3
Cirrhotic3 (Child-Pugh A)
SURVEYOR-2 |
n=24
Treatment-naïve= 100% |
12 weeks |
ABT-493 (300mg) +
|
100%
|
||||
n=24
|
12 weeks |
ABT-493 (300mg) +
|
100%
|
|||||
GT 4,5,6 Non-cirrhotic4
SURVEYOR-1 |
n=34 (GT4=22; GT5=1; GT6=11)
Treatment-naïve=85%
pegIFN/RBV treatment
|
12 weeks |
ABT-493 (300mg) + |
100%
|
||||
* Intent-to-treat (ITT) population is defined as all patients who received at least one dose of the study drugs |
||||||||
About SURVEYOR-11,4,5
SURVEYOR-1 is an ongoing Phase 2, two-part study designed to evaluate the safety and efficacy of ABT-493 and ABT-530, with or without RBV, for eight or 12 weeks, in cirrhotic and non-cirrhotic adult GT1 patients, and in non-cirrhotic GT4, 5 or 6 adult patients, with chronic HCV infection who were new to therapy or did not respond to previous treatment with pegylated interferon (pegIFN)/RBV (null responder).
About SURVEYOR-21,2,3,5
SURVEYOR-2 is an ongoing Phase 2, four-part study designed to evaluate the safety and efficacy of ABT-493 and ABT-530, with or without RBV, in adult patients with GT2, 3, 4, 5 or 6 chronic HCV infection who were new to therapy or had failed previous treatment with pegylated interferon (pegIFN)/RBV.
The primary endpoint of both studies is the percentage of subjects achieving SVR12.
Safety and efficacy data for Part 1 of the studies were presented at The Liver Meeting® 2015, the Annual Meeting of the
About pooled safety analysis of SURVEYOR-1 and SURVEYOR-25
531 patients were included in this safety analysis: 26 percent GT1, 24 percent GT2, 43 percent GT3, and 6 percent with GT4, 5, or 6 infection. Patients across genotypes received ABT-493/ABT-530 at five doses: 300/120mg (n=258), 300/120mg with RBV (n=27), 200/120mg (n=121), 200/120mg with RBV (n=56), and 200/40mg (n=69).
About Enanta
Enanta has discovered novel protease inhibitors and NS5A inhibitors that are members of the direct-acting-antiviral (DAA) inhibitor classes designed for use against the hepatitis C virus (HCV). Enanta’s protease inhibitors, developed through its collaboration with
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including statements with respect to the prospects for AbbVie’s HCV investigational treatment regimens containing 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
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1 Poordad, F et al. High SVR Rates with the Combination of ABT-493 + ABT-530 for 8 Weeks in Non-Cirrhotic Patients with HCV Genotype 1 or 2 Infection. Poster presentation #SAT-157; presented at The International Liver Congress™ (ILC), the Annual Meeting of the
2 Muir, A et al. High SVR Rates with ABT-493 + ABT-530 Co-Administered for 8 Weeks in Non-Cirrhotic Patients with HCV Genotype 3 Infection. Oral presentation #PS098; presented at The International Liver Congress™ (ILC), the Annual Meeting of the
3 Kwo, P et al. 100% SVR4 With ABT-493 and ABT-530 With or Without Ribavirin in Treatment-naïve HCV Genotype 3-infected Patients With Cirrhosis; Late Breaker presentation #LB01; presented at The International Liver Congress™ (ILC), the Annual Meeting of the
4 Gane, E et al. 100% SVR4 and Favorable Safety of ABT-493 + ABT-530 Administered for 12 Weeks in Non-Cirrhotic Patients with Genotypes 4,5, or 6 Infection (SURVEYOR-I). Poster presentation #SAT-137; presented at The International Liver Congress™ (ILC), the Annual Meeting of the
5 Kwo, P et al. Safety of ABT-493 and ABT-530 Co-Administered in Patients with HCV Genotype 1-6 Infection: Results From the SURVEYOR-I and SURVEYOR-II Studies; Poster presentation #SAT-239; presented at The International Liver Congress™ (ILC), the Annual Meeting of the
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Source:
Enanta Pharmaceuticals, Inc.
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Carol Miceli, 617-607-0710
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