Enanta Pharmaceuticals to Provide Updates on its Research and Development Programs and Outlook for 2022 at the 40th Annual J.P. Morgan Healthcare Conference
- Plans to Initiate First-in-Human Study of EDP-235, an Oral 3CL Protease Inhibitor Specifically Designed for the Treatment of COVID-19, in February 2022
- Completes Enrollment for RSVP, a Phase 2 Study of EDP-938 in Community-Acquired Respiratory Syncytial Virus (RSV) Infection in an Adult Population; Plans to Report Topline Data in the Second Quarter of 2022
- Announces RSV L-Protein Inhibitor, EDP-323, With Plans to Initiate a Phase 1 Study in the Second Half of 2022
WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage 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 across its pipeline of virology programs and plans for 2022 during Enanta’s presentation at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022 at 3:00 p.m. ET.
“As we enter 2022, we are well-positioned to execute against several upcoming milestones. We are very pleased to have completed enrollment for RSVP, our Phase 2b Study of EDP-938 for the treatment of RSV and look forward to reporting data in the second quarter of 2022,” said Jay R. Luly Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "Also in RSV, we are excited to announce an expansion of our respiratory virology program with the addition of a new clinical candidate, EDP-323, an RSV L-protein inhibitor that could be used alone or in combination with EDP-938, to treat specific patient populations or potentially broaden the treatment window. Adding to the momentum in our respiratory infection treatment portfolio, we’re eager to advance EDP-235, a novel, oral 3CL protease inhibitor specifically designed for the treatment of COVID-19, into the clinic in February 2022. As the COVID-19 pandemic continues to have a global impact, fueled in part by emerging variants such as Omicron, now more than ever there is a need for conveniently-dosed, safe and effective, oral therapeutics that are active against all variants of the SARS-CoV-2 virus. These catalysts, as well as the continued advancement of our pipeline, including our hepatitis B virus program with EDP-514, will support our mission to bring important medicines to patients in need.”
During the presentation, Dr. Luly will discuss Enanta’s pipeline program updates and expectations for 2022.
Pipeline Update and Business Review
Respiratory Syncytial Virus
- EDP-938, an N-protein inhibitor, is being evaluated in a broad clinical development program, consisting of three ongoing Phase 2 trials: RSVP, RSVPEDs and RSVTx.
- RSVP, which is designed to study the effect of EDP-938 on community-acquired RSV infection in an adult population, has completed enrollment and the company plans to report topline data in the second quarter of 2022.
- For RSVPEDs, a global, multi-center Phase 2 double-blind, placebo-controlled, dose-ranging study of EDP-938 in children aged 28 days to 24 months designed to enroll hospitalized and non-hospitalized infants and children with RSV, and RSVTx, a global, multi-center Phase 2b, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of EDP-938 in adult hematopoietic cell transplant recipients with acute RSV infection of the upper respiratory tract, Enanta expects enrollment to continue into 2023.
- EPD-323, Enanta’s newest clinical candidate for RSV, is a novel oral, direct-acting antiviral selectively targeting the RSV L-protein, a viral RNA-dependent RNA polymerase that contains multiple enzymatic activities required for RSV replication. EDP-323 has shown nanomolar potency against RSV-A and RSV-B in vitro and is not expected to have cross resistance to other classes of inhibitors. EDP-323 has the potential to be used alone or in combination with other RSV mechanisms, such as EDP-938, to broaden the treatment window or addressable patient populations. Additional preclinical data will be shared at the Conference. Enanta expects to initiate a Phase 1 study in the second half of 2022.
- Enanta is initiating a Phase 1 study of EDP-235, its oral 3CL (or main) protease inhibitor (3CLpro or Mpro) specifically designed for the treatment of COVID-19, in February 2022. Recently presented data demonstrated that EDP-235 potently blocked the replication of SARS-CoV-2 in multiple cellular models, including primary human airway epithelial cells where an EC90 of 33 nanomolar was observed, positioning EDP-235 among the most potent direct-acting antivirals currently in development for SARS-CoV-2 infection. Preclinical studies showed that EDP-235 has good oral bioavailability without ritonavir boosting and favorable distribution into lung cells as well as other key target tissues, with expected once-daily human dosing. Importantly, EDP-235 has potent antiviral activity across a range of currently circulating SARS-CoV-2 variants, as well as other human coronaviruses.
Hepatitis B Virus
- In November 2021, Enanta announced positive final data from both Phase 1b studies of EDP-514 in viremic and NUC-suppressed chronic HBV patients. EDP-514 has Fast Track Designation from the FDA and the company is focused on identifying other compounds to develop with EDP-514 in combination regimens as a functional cure for chronic HBV.
Human Metapneumovirus (hMPV)
- Enanta is continuing the development of nanomolar inhibitors of human metapneumovirus, a pathogen that causes upper and lower respiratory tract infections in young children and the elderly, as well as in immunocompromised patients or those with COPD or asthma. Clinical candidate selection is targeted for the second half of 2022.
Enanta’s presentation will take place on January 11, 2022 at 3:00 p.m. ET. A live webcast of 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 webcast will be available following the presentation and will be archived for approximately 60 days.
About Enanta Pharmaceuticals, Inc.
Enanta 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. Enanta’s research and development programs include clinical candidates currently in development for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV).
Enanta’s research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta’s clinical programs in RSV, SARS-CoV-2 and HBV and its preclinical program in hMPV. 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 impact of development, regulatory and marketing efforts of others with respect to competitive treatments for RSV, SARS-CoV-2 and HBV; the discovery and development risks of Enanta’s programs in RSV, SARS-CoV-2, HBV and hMPV; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; any continuing impact of the COVID-19 pandemic on business operations and clinical trials; Enanta’s lack of clinical development experience; Enanta’s need to attract and retain senior management and key research and development 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, 2021, and any 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.
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