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Updates on Enanta’s wholly-owned programs to be presented on
Wednesday, January 13 at 11:00 a.m. PT at the 34th Annual J.P. Morgan
Healthcare Conference
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First subject dosed in phase 1 clinical study with cyclophilin
inhibitor EDP-494 for hepatitis C virus infection
Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, announced today
that it has expanded its research and development programs within the
company’s core focus areas of virology and liver disease to include new
programs to treat hepatitis B virus (HBV) and respiratory syncytial
virus (RSV) infections. Enanta also announced that the first subject was
dosed in a phase 1 clinical study with EDP-494, its cyclophilin
inhibitor for the treatment of hepatitis C virus (HCV).
Enanta has ongoing internal research and development in four disease
areas: HCV, HBV, RSV, and non-alcoholic steatohepatitis (NASH). Updates
on all four wholly-owned programs will be presented on Wednesday,
January 13 at 11:00 a.m. PT at the 34th Annual J.P. Morgan Healthcare
Conference in San Francisco.
“Our successful HCV collaboration, our drug discovery expertise and our
experience in virology resulted in our first marketed product with
AbbVie, paritaprevir, which is part of the VIEKIRA PAK® combination HCV
therapy,” commented Jay R. Luly, Ph.D. President and Chief Executive
Officer. “We are now in a position to diversify and grow beyond HCV and
to expand our research into other areas where we can develop new
therapies for patients with limited treatment options.”
New Programs in Respiratory Syncytial Virus (RSV) and
Hepatitis B Virus (HBV)
Building on Enanta’s knowledge and experience in developing treatments
for virological diseases such as HCV, Enanta has initiated programs in
two new areas where there is a large opportunity and an unmet medical
need; RSV and HBV.
RSV is a viral lung infection that 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 age group are hospitalized due
to RSV infection.1 RSV also causes serious complications in
immune-compromised populations and the elderly.2 There are
currently no safe and effective treatments available.
HBV is a potentially life-threatening liver infection. It is estimated
that 15-25% of patients with chronic HBV infection will develop chronic
liver diseases including cirrhosis, hepatocellular carcinoma, or liver
decompensation, with more than 780,000 deaths every year due to these
complications.3
Significant progress has been made in discovering, characterizing, and
seeking patent protection for new core inhibitors for HBV and new
non-fusion inhibitors for RSV. Enanta expects to initiate phase 1
clinical development in at least one of the new programs in 2017.
EDP-494, a Cyclophilin Inhibitor for Hepatitis C Virus (HCV) Infection
In anticipation of resistance arising due to direct-acting antiviral HCV
therapies currently on the market, Enanta has developed an alternative
approach to HCV that targets the human host protein cyclophilin. Since
cyclophilin inhibitors act as host-targeted antivirals (HTA’s), the
viral mutation resistance that arises from direct-acting antiviral (DAA)
treatments would not be expected for this mechanism, and thus
cyclophilin inhibitors may have the highest barrier to resistance of any
class of HCV treatments. As the number of patients treated with the
current HCV regimens on the market increases, the treatment failure
population will continue to represent an important unmet medical need in
hepatitis C and may require new mechanisms of therapy such as
cyclophilin inhibition. Enanta recently initiated a phase 1 clinical
study of EDP-494, Enanta’s lead cyclophilin candidate. Enanta
anticipates that cyclophilin inhibitors may be combined with
direct-acting antivirals (such as nucleot(s)ide inhibitors of the NS5B
HCV target) to provide highly effective new combination treatments for
HCV.
Non- Alcoholic Steatohepatis (NASH)
NASH is a condition that results in liver inflammation and liver damage
caused by a buildup of fat in the liver. Currently there are no approved
therapies. The US prevalence is estimated to be approximately 3%-5% (~9
to15 million) of the population, 20% of whom are expected to develop
cirrhosis.4 Enanta’s initial preclinical work in NASH has
generated several promising leads with excellent potency and activity
against the clinically validated NASH target, FXR. Enanta is in the
process of conducting preclinical studies and is on track to initiate
clinical development of an FXR agonist later in 2016. In addition, a
safe and effective FXR agonist may prove to be effective in the
treatment of primary biliary cholangitis, or PBC (formerly known as
primary biliary cirrhosis), a chronic liver disease resulting from
progressive destruction of the bile ducts in the liver.
Protease Inhibitor Collaboration with AbbVie (formerly the
research-based pharmaceutical business of Abbott Laboratories)
In December 2006, Enanta and Abbott announced a worldwide agreement to
collaborate on the discovery, development and commercialization of HCV
NS3 and NS3/4A protease inhibitors and HCV-
protease-inhibitor-containing drug combinations. Paritaprevir and
ABT-493 are protease inhibitors identified through the collaboration.
Under the agreement, AbbVie is responsible for all development and
commercialization activities for the collaboration’s lead compound,
paritaprevir, as well as for ABT-493, the collaboration’s
next-generation protease inhibitor. Enanta is eligible to receive
annually tiered, double-digit royalties on AbbVie’s worldwide net sales
allocable to any of the collaboration’s protease inhibitor products and
is eligible to receive up to $80 million in approval milestones for
ABT-493.
About Enanta
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 is
currently focused on four disease targets: Hepatitis C Virus (HCV),
Hepatitis B Virus (HBV), Non-alcoholic Steatohepatitis (NASH) and
Respiratory Syncytial Virus (RSV).
Enanta has developed novel protease inhibitors and NS5A inhibitors that
are members of the direct-acting-antiviral (DAA) inhibitor classes
designed for use against the hepatitis C virus (HCV). Enanta’s protease
inhibitors, developed through its collaboration with AbbVie, include
paritaprevir, which is contained in AbbVie’s marketed DAA regimens for
HCV, and ABT-493, Enanta’s next-generation protease inhibitor which
AbbVie is developing in phase 3 studies in combination with ABT-530,
AbbVie’s next-generation NS5A inhibitor. Enanta has also discovered a
cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for
HCV, which is now in a phase 1 clinical development. Please visit www.enanta.com
for more information on our programs and pipeline.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for Enanta’s growth and
expansion into new research areas and development of new therapies, the
prospects for developing EDP-494 for resistance-associated variants of
HCV and initiating clinical development of Enanta’s programs in NASH,
HBV and RSV, and the potential for new mechanisms of action 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 discovery and
development risks of early stage discovery efforts in new disease areas
and new mechanisms of action; potential competition from the development
efforts of others in those new disease areas; 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,
2015 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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1 http://www.cdc.gov/hepatitis/hbv/bfaq.htm
2 http://www.cdc.gov/rsv/about/infection.html
3 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5750a3.htm
4 Rinella, Hepatology, 2011
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