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 new data on EDP-938, Enanta’s lead compound being developed for the treatment of Respiratory Syncytial Virus (RSV). This new data was presented by Kai Lin, Ph.D., Director of Virology, Enanta Pharmaceuticals, Inc., in an oral presentation titled “EDP-938, a Novel Non-Fusion Replication Inhibitor of Respiratory Syncytial Virus, Demonstrates Potent Antiviral Activities both In Vitro and In Vivo,” at the XIX International Symposium on Respiratory Viral Infections, Berlin, Germany.
In vitro data demonstrated that EDP-938 is a potent inhibitor of both RSV-A and RSV-B activity, maintaining antiviral activity post-infection while presenting a high barrier to resistance. Further, EDP-938 maintained antiviral potency across all clinical isolates tested as well as virus that was resistant to fusion inhibitors. The compound inhibited RSV at a post-entry, replication step and maintained its activity in vitro when given 24 hours post infection. In addition, combination studies of EDP-938 with other types of RSV inhibitors, e.g. fusion inhibitors, showed synergistic antiviral effects. New in vivo data consistent with potent inhibition of the RSV virus were also presented. EDP-938 demonstrated a greater than 4-log reduction in viral load in an animal model challenged with RSV virus.
“We are particularly encouraged by the new in vivo data, and given the favorable preclinical profile for EDP-938, we look forward to initiating a phase 1 clinical study in the fourth calendar quarter of 2017,” stated Jay R. Luly, Ph.D., President and Chief Executive Officer, Enanta.
EDP-938 is the lead non-fusion inhibitor discovered by Enanta for potential development for RSV. Enanta believes that its approach differentiates its compounds from fusion inhibitors currently in development for RSV because its non-fusion inhibitors target the virus replication machinery and have demonstrated high barriers to resistance against the virus in vitro. EDP-938 has been shown to reduce viral load below the level of detection in vivo. Additionally, non-fusion inhibitors have the potential of being effective at later stages of infection.
Respiratory syncytial virus (RSV) is a virus that infects the lungs and represents a serious unmet medical need in infants and children, as well as immune-compromised individuals and the elderly. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States. Each year, 75,000 to 125,000 children in this group are hospitalized due to RSV infection. Children with compromised (weakened) immune systems due to a medical condition or medical treatment, adults with compromised immune systems and those 65 and older are also at increased risk of severe disease. There is currently no effective treatment available for treating RSV infection.
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’s research and development efforts are currently focused on the following disease targets: non-alcoholic steatohepatitis (NASH)/ primary biliary cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B virus (HBV). Enanta has also discovered novel protease inhibitors that have been developed as part of AbbVie’s hepatitis C virus (HCV) treatment regimens under a collaboration that now provides a payment stream, which Enanta uses to fund its research and development programs. Please visit www.enanta.com for more information on Enanta’s programs and pipeline.
Forward Looking Statements
This press release contains forward-looking statements, including statements with respect to the prospects for development of EDP-938 for the treatment of RSV. 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 discovery and development risks of early stage discovery efforts in disease areas such as RSV that currently have no therapeutic treatment; potential competition from the development efforts of others in this disease area; Enanta’s lack of 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, 2016 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.