-
Data from AbbVie’s SURVEYOR-I and SURVEYOR-II studies demonstrate
high sustained virologic response rates at 12 weeks post-treatment (SVR12)
in non-cirrhotic patients with genotype 1 (GT1), genotype 2 (GT2) and
genotype 3 (GT3) chronic hepatitis C virus (HCV) infection
-
Late-breaking data demonstrate 97 percent SVR12 in
GT1 non-cirrhotic HCV patients after 8 weeks of treatment with ABT-493
and ABT-530
-
First patient enrolled in Phase 3 trials
Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA) a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today announced
data from AbbVie’s SURVEYOR studies of its investigational treatment
regimen, consisting of ABT-493, an NS3/4A protease inhibitor, and
ABT-530, an NS5A inhibitor, that show high rates of sustained virologic
response at 12 weeks post-treatment (SVR12) in non-cirrhotic
patients with chronic hepatitis C virus (HCV) infection. After 12 weeks
of treatment, SVR12 rates achieved were 97-100 percent in
genotype 1 (GT1) patients, 96-100 percent in genotype 2 (GT2), and 83-94
percent in genotype 3 (GT3).1,2,3 These data will be
presented at The Liver Meeting®, which is the Annual Meeting of the
American Association for the Study of Liver Diseases (AASLD) in San
Francisco.
Separately, in a late-breaking presentation of the SURVEYOR-1 trial,
additional data will show non-cirrhotic GT1 chronic HCV patients who
received a shorter duration of treatment for 8 weeks with ABT-493 and
ABT-530 achieved a SVR12 rate of 97 percent.4
SURVEYOR-I and SURVEYOR-II are ongoing Phase 2b clinical studies that
evaluate the safety and efficacy of treatment with combinations of
ABT-493 and ABT-530, with or without ribavirin (RBV), for 8 to 12 weeks.
The data presented at the AASLD meeting will include non-cirrhotic
patients with GT1, GT2 and GT3 chronic HCV infection. Data in additional
patient populations (genotypes 4-6) will be presented at future meetings.
About SURVEYOR-I
SURVEYOR-I is an ongoing Phase 2b two-part
study designed to evaluate the safety and efficacy of ABT-493 and
ABT-530, with or without RBV, for 8 to 12 weeks, in cirrhotic and
non-cirrhotic adult GT1 patients, and non-cirrhotic adult patients with
genotypes 4, 5 or 6 chronic HCV infection who were new to therapy or did
not respond to previous treatment with pegIFN/RBV (null responder).1,4
In Part 1 of SURVEYOR-I, with 12 weeks of treatment, no patients
discontinued treatment due to severe adverse events. The most
commonly-reported DAA-related adverse reactions (>10 percent of
patients) were fatigue, headache and nausea. One patient experienced a
serious adverse event of metastatic prostate cancer, unrelated to the
study drugs and had onset after completion of study treatment.1
In Part 2, with 8 weeks of treatment, there were no study-related
serious or severe adverse events reported. One subject discontinued the
study at treatment week 4 due to adenocarcinoma, unrelated to study
drugs. The most frequent adverse event (>5 percent of patients) was
fatigue.4
About SURVEYOR-II
SURVEYOR-II is an ongoing Phase 2b
three-part study designed to evaluate the safety and efficacy of ABT-493
and ABT-530, with or without RBV, in cirrhotic and non-cirrhotic adult
patients with GT2 or GT3 chronic HCV infection who were new to therapy
or had failed previous treatment with pegIFN/RBV.2,3 In GT2
study patients, the most commonly-reported DAA-related adverse reactions
(>10 percent of patients) were fatigue, nausea, diarrhea and headache.
No GT2 study patients discontinued treatment due to an adverse event;
one patient experienced a serious adverse event of atrial fibrillation
unrelated to the study drugs.2 In GT3 study patients, the most
commonly-reported DAA-related adverse reactions (>10 percent of
patients) were fatigue, nausea and headache. One patient discontinued
treatment due to DAA- and RBV-related adverse events of abdominal pain
and heat sensation. Two patients experienced a serious adverse event,
one with pneumonia and one with B-cell lymphoma, both unrelated to the
study drugs.3 Part 1 results of SURVEYOR-II are presented at
AASLD.
|
Overview of SURVEYOR-I and SURVEYOR-II Clinical Data Presented
at AASLD:
|
|
SURVEYOR-I (Genotype 1, Non-cirrhotic)
|
|
Number of Patients (n)/
Patient Population
|
|
|
|
Duration of Treatment
|
|
|
|
Treatment Arm
|
|
|
|
Treatment Regimen
|
|
|
|
SVR12 Rates
|
n=40
Treatment-naïve=63%
pegIFN/RBV null responders=37%
|
|
|
|
12 Weeks
|
|
|
|
Arm A
|
|
|
|
ABT-493 (200mg) + ABT-530 (120mg)
once daily
|
|
|
|
100%
(n=40/40)
|
n=39
Treatment-naïve=64%
pegIFN/RBV null responders=36%
|
|
|
|
|
|
|
Arm B
|
|
|
|
ABT-493 (200mg) + ABT-530 (40mg) once
daily
|
|
|
|
97%
(n=38/39)
|
n=34
Treatment-naïve=85%
pegIFN/RBV treatment experienced=15%
|
|
|
|
8 weeks
|
|
|
|
Arm K (n=34)
|
|
|
|
ABT-493 (300mg) + ABT-530 (120mg) once
daily
|
|
|
|
97%
(n=33/34)
|
|
SURVEYOR-II (Genotype 2, Non-cirrhotic)
|
|
Number of Patients (n)/
Patient Population
|
|
|
|
Duration of Treatment
|
|
|
|
Treatment Arm
|
|
|
|
Treatment Regimen
|
|
|
|
SVR12 Rates
|
n=74
Treatment-naïve=88%
pegIFN/RBV treatment
experienced=12%
|
|
|
|
12 weeks
|
|
|
|
Arm A
(n=25)
|
|
|
|
ABT-493 (300mg) + ABT-530 (120mg) once
daily
|
|
|
|
96%
(n=24/25)
|
|
|
|
|
|
|
Arm B
(n=24)
|
|
|
|
ABT-493 (200mg) + ABT-530 (120mg) once
daily
|
|
|
|
100%
(n=24/24)
|
|
|
|
|
|
|
Arm C
(n=25)
|
|
|
|
ABT-493 (200mg) + ABT-530 (120mg) once
daily + RBV (weight-based, 1000 or
1200mg) twice daily
|
|
|
|
100%
(n=25/25)
|
|
SURVEYOR-II (Genotype 3, Non-cirrhotic)
|
|
Number of Patients (n)/
Patient Population
|
|
|
|
Duration of Treatment
|
|
|
|
Treatment Arm
|
|
|
|
Treatment Regimen
|
|
|
|
SVR12 Rates
|
n=30
Treatment-naïve=90%
pegIFN/RBV treatment
experienced=10%
|
|
|
|
12 weeks
|
|
|
|
Arm D
|
|
|
|
ABT-493 (300mg) + ABT-530 (120mg)
once daily
|
|
|
|
93%
(n=28/30)
|
n=30
Treatment-naïve=93%
pegIFN/RBV treatment
experienced=7%
|
|
|
|
|
|
|
Arm E
|
|
|
|
ABT-493 (200mg) + ABT-530 (120mg)
once daily
|
|
|
|
93%
(n=28/30)
|
n=31
Treatment-naïve=90%
pegIFN/RBV treatment
experienced=10%
|
|
|
|
|
|
|
Arm F
|
|
|
|
ABT-493 (200mg) + ABT-530 (120mg)
once daily + RBV (weight-based, 1000 or
1200mg) twice daily
|
|
|
|
94%
(n=29/31)
|
n=30
Treatment-naïve=93%
pegIFN/RBV treatment
experienced=7%
|
|
|
|
|
|
|
Arm G
|
|
|
|
ABT-493 (200mg) + ABT-530 (40mg) once
daily
|
|
|
|
83%
(n=25/30)
|
Protease Inhibitor Collaboration with AbbVie
In December
2006, Enanta and Abbott announced a worldwide agreement to collaborate
on the discovery, development and commercialization of HCV NS3 and
NS3/4A protease inhibitors and HCV-protease-inhibitor-containing drug
combinations. ABT-493 is a protease inhibitor identified through the
collaboration, as is paritaprevir, which is part of AbbVie’s existing
approved regimens for HCV. AbbVie is Abbott’s successor under the
agreement and is responsible for all development and commercialization
activities for ABT-493, as well as paritaprevir.
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 has
developed novel protease 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 partnered with
AbbVie include paritaprevir, which is contained in AbbVie’s marketed DAA
regimens for HCV, and ABT-493, Enanta’s next-generation protease
inhibitor completing phase 2 development in combination with ABT-530,
AbbVie’s next-generation NS5A inhibitor. Enanta also has a program to
develop a host-targeted antiviral (HTA) inhibitor class for HCV targeted
against cyclophilin, as well as another DAA program to develop
nucleotide polymerase inhibitors. In addition, Enanta has a preclinical
program in non-alcoholic steatohepatitis, or NASH, which is a condition
that results in liver inflammation and liver damage caused by a buildup
of fat in the liver.
Forward Looking Statements Disclaimer
This press release
contains forward-looking statements, including statements with respect
to the prospects for AbbVie’s next-generation treatment regimen under
development for HCV. 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 AbbVie
(our collaborator on ABT-493) regarding clinical development of
ABT-493-containing regimens; the impact of competitive products on the
regulatory requirements, use and sales of any ABT-493-containing
regimen; 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, 2014 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.
1 Poordad, F., et al. SURVEYOR-I: 98% – 100% SVR4 in HCV
Genotype 1 Non-Cirrhotic Treatment-Naïve or Pegylated
Interferon/Ribavirin Null-Responders with the Combination of the Next
Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530;
Oral presentation #41; presented at The Liver Meeting®, the Annual
Meeting of the American Association for the Study of Liver Diseases
(AASLD) in San Francisco, November 13-17, 2015.
2 Wyles, D., et al. SURVEYOR-II: High SVR4 Rates Achieved
With the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A
Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and
Treatment-Experienced Patients With HCV Genotype 2 Infection; Oral
presentation #250; presented at The Liver Meeting®, the Annual Meeting
of the American Association for the Study of Liver Diseases (AASLD) in
San Francisco, November 13-17, 2015.
3 Kwo, P, et al. SURVEYOR-II: High SVR4 Rates Achieved With
the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor
ABT-530 In Non-Cirrhotic Treatment-Naïve and Treatment-Experienced
Patients With HCV Genotype 3 Infection; Oral presentation #248;
presented at The Liver Meeting®, the Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD) in San Francisco,
November 13-17, 2015.
4 Poordad, F., et al. 100% SVR4 in HCV Genotype 1
Non-Cirrhotic Treatment-Naïve or -Experienced Patients With the
Combination of ABT-493 and ABT-530 for 8 Weeks (SURVEYOR-I); Poster
presentation #; presented at The Liver Meeting®, the Annual Meeting of
the American Association for the Study of Liver Diseases (AASLD) in San
Francisco, November 13-17, 2015.
![](http://cts.businesswire.com/ct/CT?id=bwnews&sty=20151116005852r1&sid=ntxv4&distro=nx&lang=en)
View source version on businesswire.com: http://www.businesswire.com/news/home/20151116005852/en/
Copyright Business Wire 2015