Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported an update on its clinical trial activities in response to the COVID-19 pandemic. In order to ensure the safety of clinical trial participants, and also in accordance with the recently issued guidance documents of the U.S. Food and Drug Administration, European Medicines Agency and Medicines and Healthcare products Regulatory Agency, Enanta is making adjustments to some of its ongoing clinical studies.
"The COVID-19 pandemic represents a significant, ongoing public health threat and has created an unprecedented burden on healthcare systems across the globe. With the safety of our clinical trial participants in mind, coupled with a desire to alleviate many of the resource constraints at clinical trial sites, Enanta has proactively decided to make adjustments to some of our clinical programs," said Jay R. Luly, President and Chief Executive Officer of Enanta. "While we were poised to begin dosing the ARGON-2 Phase 2b NASH study this week, we have paused recruitment and dosing in this study, and we are pausing further recruitment in Part 2 of our Phase 1a/1b study of EDP-514 in nuc-suppressed hepatitis B (HBV) patients, which initiated earlier this quarter."
Dr. Luly added, "As planned, we are continuing to prepare to initiate our two Phase 2 respiratory syncytial virus (RSV) studies of EDP-938 in pediatric and transplant patients later this year. We also are hopeful we will be able to conduct our Phase 1b study of EDP-514 in viremic HBV patients, as well as our first-in-human study of EDP-297 for NASH, substantially on schedule. Further, we have already completed the RSV season in the U.S. and are continuing with plans to shift our RSVP study to the Southern Hemisphere. We do not anticipate any supply disruption for any of these trials. All of our plans are subject to change, though, as the COVID-19 pandemic rapidly evolves, but fortunately we have sufficient cash resources to bridge us across the current COVID-19 disruption. Meanwhile, in the coming weeks we plan to announce data from our INTREPID study of EDP-305 in patients with primary biliary cholangitis."
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 efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH)/ primary biliary cholangitis (PBC), hepatitis B virus (HBV), human metapneumovirus (hMPV) and emerging coronaviruses.
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 and now marketed by AbbVie as part of its leading treatment for chronic HCV infection, is sold under the brand names 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 impact of COVID-19 on Enanta’s clinical development programs. 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 the rapidly evolving COVID-19 pandemic on clinical study participants and clinical trial sites and their healthcare personnel involved in Enanta’s ongoing clinical trials and those that would be expected to become involved in its planned clinical trials; the uncertain extent of government actions taken to date and any additional actions that may be taken in the future and their impact on Enanta’s clinical trial activities; competition for scarce healthcare resources that may need to be dedicated to the COVID-19 pandemic rather than clinical trials; and other risk factors described or referred to in "Risk Factors" in Enanta’s most recent Form 10-Q for the fiscal quarter ended December 31, 2019 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.