Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation to Pfizer’s
investigational combination therapy for the treatment of
non-alcoholic steatohepatitis (NASH) with liver fibrosis:
ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2
inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA
carboxylase inhibitor, or ACCi). Fast Track is a process designed
to facilitate the development and expedite the review of new drugs
and vaccines intended to treat or prevent serious conditions and
address unmet medical need.
The FDA’s decision is informed by the results of Pfizer’s
nonclinical studies and a Phase 2a clinical study of
ervogastat/clesacostat, which showed that treatment with
ervogastat/clesacostat reduced liver fat with a favorable safety
and tolerability profile. These data were recently published in
Nature Medicine.
“Receiving Fast Track designation from the FDA reinforces
Pfizer’s belief in ervogastat/clesacostat as a potential treatment
for NASH, a serious, progressive liver disease with no currently
approved therapies,” said James Rusnak, M.D., Ph.D., Senior Vice
President and Chief Development Officer, Internal Medicine and
Hospital, Pfizer. “We are proud to be advancing this
investigational combination as part of our goal to develop
innovative medicines to address some of the world’s most widespread
health challenges that affect millions of people—including diseases
like NASH.”
Pfizer is currently studying ervogastat/clesacostat in an
ongoing Phase 2 clinical trial evaluating the impact of treatment
on resolution of NASH or improvement in liver fibrosis
(NCT04321031), expected to complete in 2024. The results of this
study, which also includes arms investigating ervogastat as
monotherapy, will inform a potential Phase 3 development
program.
About NASH Non-alcoholic steatohepatitis (NASH) is a
serious, progressive form of non-alcoholic fatty liver disease
(NAFLD) caused by a buildup of fat in the liver and accompanied by
inflammation, liver cell damage, and in some cases scarring of the
liver.1,2 Approximately 17 million patients in the U.S. are
impacted by NASH (and 3-5% of the global adult population), a
number that is predicted to grow significantly over the next 10-15
years due to increases in obesity and Type 2 diabetes prevalence
and an aging population.3,4 NASH is largely unrecognized and
underdiagnosed, increasing patients’ risk of morbidity, liver
events and mortality.5,6,7 There are currently no FDA- or
EMA-approved medications to treat NASH, and Pfizer researchers are
working to develop treatments for the disease to fill this
significant unmet medical need.
About Ervogastat/Clesacostat Diacylglycerol
O-acyltransferase 2 (DGAT2) and acetyl-CoA carboxylase (ACC) are
two key enzymes that regulate lipid metabolism. Inhibitors of ACC
and DGAT2 have demonstrated the ability to lower liver fat in
patients with non-alcoholic fatty liver disease (NAFLD).8 Pfizer
believes that ervogastat/clesacostat, its investigational
DGAT2i/ACCi combination therapy, has the potential to deliver
direct improvements in inflammation and fibrosis.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 170 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.Pfizer.com. In addition, to
learn more, please visit us on www.Pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
References 1National Institute of Diabetes and Digestive
and Kidney Diseases. Definition and Facts of NAFLD and NASH.
Accessed May 14, 2021.
https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/definition-facts.
2Perumpail, Brandon J et al. “Clinical epidemiology and disease
burden of nonalcoholic fatty liver disease.” World journal of
gastroenterology vol. 23,47 (2017): 8263-8276.
doi:10.3748/wjg.v23.i47.8263. 3Estes C, Razavi H, Loomba, R,
Tounossi Z, Sanyal Aj. Modeling the Epidemic of Nonalcoholic Fatty
Liver Disease Demonstrates an Exponential Increase in Burden of
Disease. Hepatology. 2018;67(1):123-133. 4Povsic M, Wong OY, Perry
R, Bottomley J. A Structured Literature Review of the Epidemiology
and Disease Burden of Non-Alcoholic Steatohepatitis (NASH). Adv
Ther. 2019;36(7):1574-1594. doi:10.1007/s12325-019-00960-3 5Machado
MV, Cortez-Pinto H. Non-alcoholic fatty liver disease: what the
clinician needs to know. World J Gastroenterol.
2014;20(36):12956-12980. doi:10.3748/wjg.v20.i36.12956 6Rinella ME,
Lominadze Z, Loomba R, et al. Practice patterns in NAFLD and NASH:
real life differs from published guidelines. Therap Adv
Gastroenterol. 2016;9(1):4-12. doi:10.1177/1756283X15611581 7Kumar
R, Priyadarshi RN, Anand U. Non-alcoholic Fatty Liver Disease:
Growing Burden, Adverse Outcomes and Associations. J Clin Transl
Hepatol. 2020;8(1):76-86. doi: 10.14218/JCTH.2019.00051. 8Esler WP,
Bence KK. Metabolic Targets in Nonalcoholic Fatty Liver Disease.
Cellular and molecular gastroenterology and hepatology.
2019;8(2):247-267. doi:10.1016/j.jcmgh.2019.04.007
Disclosure Notice The information contained in this
release is as of May 26, 2022. Pfizer assumes no obligation to
update forward-looking statements contained in this release as the
result of new information or future events or developments.
This release contains forward-looking information about Pfizer’s
investigational combination therapy for the treatment of
non-alcoholic steatohepatitis with liver fibrosis:
ervogastat/clesacostat, including its potential benefits and a
potential Phase 3 development program, that involves substantial
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for our clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, as well as
the possibility of unfavorable new clinical data and further
analyses of existing clinical data; the risk that clinical trial
data are subject to differing interpretations and assessments by
regulatory authorities; whether regulatory authorities will be
satisfied with the design of and results from our clinical studies;
whether and when drug applications may be filed in any
jurisdictions for ervogastat/clesacostat; whether and when any such
applications may be approved by regulatory authorities, which will
depend on myriad factors, including making a determination as to
whether the product's benefits outweigh its known risks and
determination of the product's efficacy and, if approved, whether
ervogastat/clesacostat will be commercially successful; decisions
by regulatory authorities impacting labeling, manufacturing
processes, safety and/or other matters that could affect the
availability or commercial potential of ervogastat/clesacostat; the
impact of COVID-19 on Pfizer’s business, operations and financial
results; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2021 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
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