Enanta Pharmaceuticals to Provide Updates on its Research and Development Programs and Business Outlook for 2018 during the 36th Annual J.P. Morgan Healthcare Conference
- Phase 2 clinical study “INTREPID” of EDP-305 in patients with primary biliary cholangitis initiated
- Phase 1 clinical study of EDP-938 for respiratory syncytial virus initiated
Strong cash balance of
$294Mas of September 30, 2017to support advancing R&D programs
“Enanta has executed well on its stated goals and as a result has
achieved significant clinical progress,” stated
The following are details of Enanta’s research and development program updates and expectations for 2018.
Research and Development Update:
EDP-305, FXR agonist for NASH/PBC:
- A Phase 2 dose-ranging clinical study of EDP-305, Enanta’s lead FXR agonist, has been initiated in patients with PBC. The Phase 2 clinical study, “INTREPID”, is a 12-week, randomized, double blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and efficacy of EDP-305 in subjects with PBC, with or without an inadequate response to ursodeoxycholic acid. The efficacy of EDP-305 will be assessed by evaluating reductions in levels of alkaline phosphatase versus placebo.
- Enanta plans to initiate a Phase 2 dose-ranging clinical study of EDP-305 in NASH patients in early 2018.
The U.S. Food and Drug Administrationhas granted EDP-305 Fast Track designation for the treatment of NASH patients with liver fibrosis and Fast Track designation for the treatment of patients with PBC.
Data is being presented at the 2018 NASH-TAG conference in
Park City, Utah, January 4-6, 2018, from Enanta’s Phase 1 study of EDP-305 in healthy subjects and in subjects with presumptive non-alcoholic fatty liver disease (NAFLD). Top line results were first announced on October 23, 2017, and data from this trial studying the safety, pharmacokinetic, and pharmacodynamic properties of EDP-305 support further clinical evaluation of EDP-305 in NASH and PBC patients.
Respiratory Syncytial Virus:
- A Phase 1 clinical study of EDP-938, a potent non-fusion inhibitor of both RSV-A and RSV-B activity, has been initiated. The objective of the study is to evaluate the safety, tolerability and pharmacokinetics of single ascending dose (SAD) and multiple ascending dose (MAD) levels of EDP-938 in healthy volunteers. Upon successful completion of this study, a Phase 2 proof-of-concept challenge study in RSV-infected humans is expected to begin later in 2018.
Hepatitis B Virus:
- Enanta’s current research efforts in HBV are focused on core inhibitors, with the aim of developing a functional cure. Preclinical lead optimization continues to progress, with the goal of identifying a development candidate in 2018.
Licensed Products Update
Glecaprevir and paritaprevir, protease inhibitors for Hepatitis C Virus (HCV):
Glecaprevir, Enanta’s second protease inhibitor developed through its
AbbVie, is one of the two new direct-acting antivirals in AbbVie’s new pan-genotypic glecaprevir/pibrentasvir combination for chronic HCV treatment now being marketed in the U.S., EU, Japan, and other jurisdictions under the tradenames MAVYRET™ (U.S.) or MAVIRET™ (ex-U.S.).
Enanta has earned all of the clinical and regulatory milestones for
two products, paritaprevir and glecaprevir, within the Enanta/
AbbVieHCV collaboration, and continues to receive royalties on both products. Total cash received from AbbVieunder the collaboration through December 31, 2017totaled approximately $526 million dollars.
Enanta’s presentation will take place on
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-305 and EDP-938, the prospects for AbbVie’s MAVYRET™
/MAVIRET™ (glecaprevir/pibrentasvir) regimen for HCV generating
additional royalties for Enanta, and the prospects for further
development in Enanta’s HBV program. 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
NASH, PBC, RSV and HBV; Enanta’s revenues in the short-term are
dependent upon the success of AbbVie’s continuing commercialization
efforts for its new MAVYRET/MAVIRET regimen; the impact of development,
regulatory and marketing efforts of others with respect to competitive
treatments for NASH, PBC, RSV, HCV or HBV; reimbursement actions
affecting 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