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Enanta Pharmaceuticals Announces Data Presentations
at The Liver Meeting® 2015
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ICAAC: New HCV NS5A Inhibitor - (09/30/15)
ICAAC: Pharmacokinetics, Safety and Tolerability of EDP-239, a Novel Hepatitis C (HCV) NS5A inhibitor, in Patients with HCV Infection - (09/30/15)
ICAAC: Pharmacokinetics, Safety, and Tolerability of EDP-239, a novel Hepatitis C NS5A inhibitor, in Healthy Volunteers - (09/30/15)
· New data on studies of VIEKIRA PAK™, (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Genotype 1 Hepatitis C Patients
· SVR4 data from new studies of Enanta's next-generation protease inhibitor, ABT-493, in combination with AbbVie's next-generation protease inhibitor, ABT-530
October 01, 2015
WATERTOWN, Mass.--(BUSINESS WIRE)--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 that 34 abstracts from AbbVie's chronic hepatitis C clinical development program have been accepted for presentation at the Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) taking place November 13-17, 2015 in San Francisco.
Several presentations will report data from AbbVie's ongoing clinical development program of regimens containing Enanta's lead protease inhibitor, paritaprevir, identified within the ongoing collaboration with AbbVie. Presentations will highlight new data from phase 3b studies of AbbVie's FDA-approved VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) for adults with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, taken with or without ribavirin, including studies of GT1 patients with chronic kidney disease and genotype 1b (GT1b) patients with compensated cirrhosis.
Additionally, new clinical studies will be presented showing SVR4 data for ABT-493, Enanta's next-generation HCV protease inhibitor, in combination with ABT-530, AbbVie's next-generation NS5A inhibitor, focused on investigating pan-genotypic, ribavirin-free, once-daily treatment options that may allow for shorter treatment durations of as little as eight weeks.
There will also be several studies presented in health economics outcomes research examining VIEKIRA PAK as well as the impact of hepatitis C.
In addition, three posters will be presented on EDP-239, Enanta's wholly-owned NS5A inhibitor that has completed a phase 1a/b study and proof of concept study in HCV patients.
Abstracts can now be viewed at the AASLD website at www.aasld.org.
Select AbbVie Presentations at AASLD 2015 include:
· RUBY-I: Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir +/- Ribavirin in Non-Cirrhotic HCV Genotype 1-infected Patients With Severe Renal Impairment or End-Stage Renal Disease; Pockros, et al.
- Poster #1039
- November 15, 8:00 a.m. - 5:30 p.m. PT, Hepatitis C: Therapeutics (Approved Agents)
- RUBY-I is an ongoing open-label study evaluating 3D+/-RBV in patients with stage four or five chronic kidney disease and GT1 infection.
· TURQUOISE-III: 12-Week Ribavirin-Free Regimen of Ombitasvir/Paritaprevir/r and Dasabuvir for Patients with HCV Genotype 1b and Cirrhosis; Poordad, et al.
- Poster #1051
- November 15, 8:00 a.m. - 5:30 p.m. PT, Hepatitis C: Therapeutics (Approved Agents)
- Hepatitis C virus infected patients have historically been more difficult to treat when they have cirrhosis. This poster reports on the safety and efficacy of the 3D regimen without RBV in patients with HCV GT1b infection and compensated cirrhosis. VIEKIRA PAK is not recommended for patients with decompensated liver disease.
· Efficacy, Change in MELD Score, and Safety by Baseline MELD Score in Patients With Compensated Cirrhosis Receiving Ombitasvir/Paritaprevir/r and Dasabuvir Plus Ribavirin in Phase 3 TURQUOISE-II Trial; Jacobson, I, et al.
- Poster #1106
- November 15, 8:00 a.m. - 5:30 p.m. PT, Hepatitis C: Therapeutics (Approved Agents)
- Model for end-stage liver disease (MELD) scores assess liver disease severity. In this analysis, the efficacy and safety of 3D+RBV and changes in MELD score by baseline MELD score is evaluated.
Preliminary Safety and Efficacy Results in TOPAZ-II: A Phase 3b Study Evaluating Long-Term Clinical Outcomes in HCV Genotype 1-infected Patients Receiving Ombitasvir/Paritaprevir/r and Dasabuvir +/-Ribavirin; Reau, N, et al.
- Poster #1065
- November 15, 8:00 a.m. - 5:30 p.m. PT, Hepatitis C: Therapeutics (Approved Agents)
- TOPAZ-I (ex-U.S.) and TOPAZ-II (U.S.) are evaluating the impact of SVR12 on the progression of liver disease through five years post-treatment in a broad population of HCV GT1-infected patients receiving 3D+/-RBV. This interim analysis reports on-treatment safety and efficacy of 3D+/-RBV among patients in the TOPAZ-II study.
· Long-Term Efficacy of Ombitasvir/Paritaprevir/r and Dasabuvir With or Without Ribavirin in HCV GT1-Infected Patients with or without Cirrhosis; Zeuzem, S, et al.
- Poster #1086
- November 15, 8:00 a.m. - 5:30 p.m. PT, Hepatitis C: Therapeutics (Approved Agents)
- In this analysis, the efficacy through post-treatment week 48 of the 3D regimen in HCV GT1-infected patients with or without cirrhosis is examined.
· SVR4 Results in HCV Genotype 1 Non-Cirrhotic Treatment-Naïve or Pegylated Interferon/Ribavirin Null Responders with the Combination of the NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 (SURVEYOR-1); Poordad, F, et al.
- Oral presentation #41
- November 15, 4:00 p.m. - 4:15 p.m. PT, Parallel Session 5, Hep C Clinical Trials
- In this phase 2 study, treatment with ABT-493 and ABT-530 for 12 weeks is evaluated in HCV GT1-infected subjects without cirrhosis. Efficacy and safety results are reported.
· SVR4 Rates with the NS3/4A Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 2 Infection (SURVEYOR-2); Wyles, D, et al.
- Oral presentation #250
- November 17, 12:00 p.m. - 12:15 p.m. PT, General Session, Parallel 37: Hepatitis C: Pre-approval Clinical Studies II
- This presentation evaluates the efficacy and safety of ABT-493 and ABT-530 with or without RBV in non-cirrhotic GT2-infected treatment-naïve and pegylated interferon/RBV treatment-experienced subjects.
· SVR4 Rates with the NS3/4A Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 3 Infection (SURVEYOR-2); Kwo, P, et al.
- Oral presentation #248, General Session
- November 17, 11:30 a.m.- 11:45 a.m. PT, Parallel 37: Hepatitis C:
Pre-approval Clinical Studies II
- This presentation evaluates the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in non-cirrhotic GT3-infected treatment-naïve and pegylated interferon/RBV treatment-experienced subjects.
Health Economics and Outcomes Research (HEOR) Abstracts:
· Lifetime Risks of Liver Morbidity and Mortality in Patients with Chronic Genotype 1 Hepatitis C Virus and HIV Coinfection Treated with 3D±R (Ombitasvir/ Paritaprevir/ Ritonavir, Dasabuvir ± Ribavirin) vs other Standards of Care in the U.S.; Saab, S, et al.
- Poster #1087
- November 15, 8:00 a.m. - 5:30 p.m. PT, Hepatitis C: Therapeutics (Approved Agents)
- This study evaluates the lifetime risks of liver morbidity and mortality in patients with GT1 HCV and HIV coinfection treated with 3D±R for 12 or 24 weeks compared to other standards of care in the U.S.
· The Healthcare Cost Burden of HCV-infected Baby Boomers in the U.S.; Brookmeyer, R, et al.
- Poster #1068
- November 15, 8:00 a.m. - 5:30 p.m. PT, Hepatitis C: Therapeutics (Approved Agents)
- This study quantifies healthcare costs for 50-64 year-old "baby boomers" with HCV by diagnosis and insurance status.
Enanta Presentations on EDP-239
· Pharmacokinetics, Safety and Tolerability of EDP-239, a Novel Hepatitis C (HCV) NS5A Inhibitor, in Patients with HCV Infection; Jiang, L, et al.
- Poster #2260
- November 17, 8:00 a.m. - 12:00 p.m. PT, Therapeutics: Preclinical and Early Clinical Development
- This study assessed the pharmacokinetics, safety and tolerability of EDP-239 in a randomized, double-blind, placebo-controlled study in HCV patients.
· Pharmacokinetics, Safety and Tolerability of EDP-239, a Novel Hepatitis C (HCV) NS5A Inhibitor, in Healthy Volunteers; Jiang, L, et al.
- Poster #2259
- November 17, 8:00 a.m. - 12:00 p.m. PT, Therapeutics: Preclinical and Early Clinical Development
- This study assessed the pharmacokinetics, safety and tolerability of EDP-239 in a randomized, double-blind, placebo-controlled study in healthy volunteers.
· EDP-239, a Novel HCV NS5A Inhibitor, Demonstrate Potent Antiviral Activity After a Single Dose Treatment of Genotype 1 HCV Patients; Lawitz, E, et al.
- Poster #2257
- November 17, 8:00 a.m. - 12:00 p.m. PT, Therapeutics: Preclinical and Early Clinical Development
- This study evaluates the maximum viral load reductions of EDP-239 after a single dose in genotype 1 HCV patients.
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. 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 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 next-generation AbbVie 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.
Contacts
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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