Enanta Announces New Data on ABT-450 Regimens to be Presented at The Liver Meeting (AASLD)
WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc., (Nasdaq: ENTA ) a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that six abstracts reporting results of regimens containing ABT-450, Enanta’s lead protease inhibitor for hepatitis C virus (HCV), have been accepted for presentation at The Liver Meeting, the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) taking place November 1-5, 2013 in Washington, D.C. Abstracts can now be viewed at the AASLD website at www.aasld.org.
There will be an oral presentation at AASLD highlighting data from study M13-393 (PEARL-I). PEARL-I is an interferon-free and ribavirin-free 320-patient study being conducted by Abbvie to evaluate the once-daily, two-DAA regimen consisting of ABT-450/r + ABT-267 in GT-1b and GT-4 HCV patients. SVR4 rates were 100% (39/39) in GT-1b treatment-naïve patients and 87.9% (29/33) among prior null responders (observed data). SVR12 rates will be presented during an oral presentation of this data on November 3.
Abstracts reporting regimens containing ABT-450 are listed below:
- #75 - Interferon and Ribavirin-Free Regimen of ABT-450/r + ABT-267 in HCV Genotype 1b-infected Treatment-naïve Patients and Prior Null Responders
Lawitz, et al., November 3, 2013, 5:15 PM ET
- #1089 - Low Relapse Rate Leads to High Concordance of SVR4 and SVR12 with SVR24 After Treatment with ABT-450/r, ABT-267, ABT-333 + Ribavirin in Patients with Chronic HCV Genotype 1 Infection in the AVIATOR Study
Poordad, et al., November 3, 2013, 8:00 AM – 5:30 PM ET
- #1096 - High Medication Adherence in HCV-Infected Patients taking a Triple-DAA Regimen for 12 Weeks
Bourliere, et al., November 3, 2013, 8:00 AM – 5:30 PM ET
- #1125 - HCV RNA “Target Detected” after “Target Not Detected” During IFN-Free Treatment: Time to Worry or Not?
M King, et al., November 3, 2013, 8:00 AM – 5:30 PM ET
- #1118 - Safety of Ribavirin-containing Regimens of ABT-450/r, ABT-333, and ABT-267 for the Treatment of HCV Genotype 1 Infection and Efficacy in Subjects with Ribavirin Dose Reductions
Cohen, et al., November 3, 2013, 8:00 AM – 5:30 PM ET
- #1113 - Health-Related Quality of Life (HRQoL), Health State, Function and Wellbeing of Chronic HCV Patients Treated with Interferon-Free, Oral DAA Regimens: Patient Reported Outcome (PRO) Results from the AVIATOR Study
Baran, et al., November 3, 2013, 8:00 AM – 5:30 PM ET
Protease Inhibitor Collaboration with AbbVie (formerly the research-based pharmaceutical business of Abbott Laboratories)
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-450 is a protease inhibitor identified as a lead compound through the collaboration. Under the agreement, AbbVie (as the successor to Abbott) is responsible for all development and commercialization activities for ABT-450. Enanta received $57 million in connection with signing the collaboration agreement, has received $55 million in subsequent clinical milestone payments, and is eligible to receive an additional $195 million in payments for regulatory milestones, as well as double-digit royalties worldwide on any revenue allocable to the collaboration’s protease inhibitors. Also, for any additional collaborative HCV protease inhibitor product candidate developed under the agreement, Enanta holds an option to modify the U.S. portion of it rights to receive milestone payments and worldwide royalties. With this option, Enanta can fund 40 percent of U.S. development costs and U.S. commercialization efforts (sales and promotion costs) for the additional protease inhibitor in exchange for 40 percent of any U.S. profits ultimately achieved after regulatory approval instead of receiving payments for U.S. commercial regulatory approval milestones and royalties on U.S. sales of that protease inhibitor.
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 in the infectious disease field. Enanta is discovering and developing novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes – protease (partnered with AbbVie), NS5A (partnered with Novartis) and nucleotide polymerase – as well as a host-targeted antiviral (HTA) inhibitor class targeted against cyclophilin. Additionally, Enanta has created a new class of antibiotics, called Bicyclolides, for the treatment of multi-drug resistant bacteria, with a focus on developing an intravenous and oral treatment for hospital and community MRSA (methicillin-resistant Staphylococcus aureus) infections.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including with respect to clinical data, plans for announcing additional data, and the planned clinical development of ABT-450. 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 final results of ongoing clinical trials, the development and marketing efforts of AbbVie (our collaborator on ABT-450), regulatory actions affecting clinical development of ABT-450 and clinical development of competitive product candidates. 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.
KEYWORDS: United States North America District of Columbia Massachusetts