WATERTOWN, Mass.--(BUSINESS WIRE)--
- Topline Phase 2 RSV challenge study data now anticipated mid-2019
- Phase 1 clinical study of HBV core inhibitor EDP-514 planned to begin second half of 2019
- HCV royalty revenue of $191.6 million in fiscal 2018 and strong cash balance of $325 million as of September 30, 2018 support Enanta’s expanding R&D programs
Enanta Pharmaceuticals, Inc. (ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., Enanta’s President and Chief Executive Officer, will provide an update on its research and development programs in respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH)/primary biliary cholangitis (PBC), and discuss its business outlook for 2019 during Enanta’s presentation at the 37th Annual J.P. Morgan Healthcare Conference on January 7, 2019 at 4:30 p.m. Pacific time.
“Enanta continues to execute on its goals and has never been in a stronger position from both a financial and clinical development perspective,” said Jay R. Luly, Ph.D. President and CEO, Enanta Pharmaceuticals. “Throughout 2019, Enanta has several milestones to look forward to, including Phase 2a clinical datasets from our RSV human challenge study and our Argon-1 NASH study, as well as the first in human study of our lead HBV candidate, EDP-514.”
The following are details of Enanta’s research and development program updates and expectations for 2019.
Research and Development Events Planned for Calendar 2019:
EDP-938, N-Protein Inhibitor for Respiratory Syncytial Virus:
- Dosing is ongoing in a Phase 2a human challenge study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of EDP-938 orally administered to healthy subjects infected with a strain of respiratory syncytial virus. The trial is advancing well, and topline data is now expected mid-2019.
EDP-514, Core Inhibitor for Hepatitis B Virus:
- Pre-clinical data on EDP-514, a promising inhibitor of the HBV core protein, will be presented during the formal presentation on January 7. Data presented on EDP-514 will demonstrate potent inhibition of HBV replication in vitro accompanied by a greater than 4-log viral load reduction in vivo.
- A Phase 1 study of EDP-514, is planned to begin in the second half of 2019. The study will evaluate single and multiple doses of drug in healthy volunteers and will incorporate a Phase 1b arm in patients with chronic HBV infection.
EDP-305, FXR agonist for NASH:
- Enrollment in the 12-week Phase 2a NASH trial is expected to conclude in the first quarter of 2019 allowing Enanta to report preliminary top line data in the third quarter of 2019.
- Enanta also expects to identify an FXR follow-on clinical candidate in 2019.
Enanta’s presentation will take place on January 7, 2019 beginning at 4:30 p.m. Pacific Time. A live webcast of the presentation, as well as the question and answer breakout session that follows the presentation, will be accessible by visiting the “Events and Presentations” section on the “Investors” page of Enanta’s website at www.enanta.com. A replay of the webcasts will be available following the presentation and will be archived for approximately 60 days.
Enanta Pharmaceuticals is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Glecaprevir, a protease inhibitor discovered by Enanta, has been developed by AbbVie, and is now approved and sold in numerous countries as part of AbbVie’s newest treatment for chronic hepatitis C virus (HCV) infection. This leading HCV regimen is sold under the tradenames MAVYRET™ (U.S.) and MAVIRET™ (ex-U.S.) (glecaprevir/pibrentasvir). Ongoing royalties from the AbbVie collaboration are helping to fund Enanta’s research and development efforts, which are currently focused on the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), and hepatitis B virus (HBV). Please visit www.enanta.com for more information.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including statements with respect to the prospects for Enanta’s further development of EDP-938, EDP-305 and EDP-314 for RSV, NASH/PBC and HBV, respectively, and the prospects for additional royalties for Enanta from AbbVie’s sales of MAVYRET™ /MAVIRET™ (glecaprevir/pibrentasvir) regimen for HCV. 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 development risks of early stage discovery efforts in new disease areas in Enanta’s research and development efforts, such as RSV, NASH, PBC and HBV; Enanta’s revenues in the short-term are dependent upon the continued success of AbbVie’s commercialization of its MAVYRET/MAVIRET regimen; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for HCV, NASH, PBC, RSV and HBV; reimbursement actions affecting MAVYRET/MAVIRET or any competitive treatment for HCV; Enanta’s limited clinical development experience; Enanta’s need to attract and retain senior management and key scientific personnel; Enanta’s need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; 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, 2018 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.