-- Results from First Phase 2 Trial
Describing a Triple Combination Regimen Targeting NASH Presented at
The Liver Meeting Digital Experience --
Gilead Sciences, Inc. (Nasdaq: GILD) and Novo Nordisk A/S
(NASDAQ Copenhagen: NOVO B) today announced results from a Phase 2
proof-of-concept trial. The five-arm trial evaluated combinations
of Novo Nordisk’s semaglutide, a GLP-1 receptor agonist, with
Gilead’s investigational FXR agonist cilofexor and/or Gilead’s
investigational ACC inhibitor firsocostat over 24 weeks in 108
people with non-alcoholic steatohepatitis (NASH). The results were
presented at The Liver Meeting Digital Experience™ (TLMdX),
November 13–16, 2020 (Late Breaker #L02).
The trial met its primary endpoint by demonstrating that in
people with NASH and mild to moderate fibrosis all regimens were
well tolerated. The most common adverse events (AEs) were
gastrointestinal. Minimal pruritus (itching) was observed in people
treated with cilofexor. Across all groups, 5–14% of people
discontinued any trial treatment due to AEs. Exploratory efficacy
endpoints assessing biomarkers of liver health at 24 weeks in
post-hoc analyses showed statistically significant improvements in
hepatic steatosis (measured by magnetic resonance imaging proton
density fat fraction; MRI-PDFF) and liver injury (measured by serum
alanine aminotransferase; ALT) in the combination arms versus
semaglutide alone. Although liver stiffness measured by
vibration-controlled transient elastography (VCTE) and enhanced
liver fibrosis (ELF) score declined in all groups, statistically
significant differences between groups were not observed.
“These results offer novel insights around the multiple
mechanisms that drive NASH and demonstrate the potential of
combination approaches for patients in significant need of a
treatment option for this condition,” said Naim Alkhouri, MD,
Director of the Fatty Liver Program, Chief of Transplant
Hepatology, Arizona Liver Health, Chandler. “We are encouraged that
these data showcase the potential for combination approaches to
elicit improvements in liver fat content, liver biochemistry, and
certain non-invasive tests of fibrosis, all of which have been
associated with meaningful histologic improvement in NASH.”
“Gilead is focused on delivering scientific advances that can
improve the lives of people with liver disease, both through our
own innovation and in partnership with companies with complementary
expertise, such as Novo Nordisk,” said Mark Genovese, MD, Senior
Vice President, Inflammation Clinical Development at Gilead
Sciences. “These data offer new insights into potential therapeutic
approaches to treating NASH, a disease which currently has limited
treatment options.”
“This trial brings together Gilead and Novo Nordisk’s respective
expertise and science to provide important insights into potential
new combination therapies involving semaglutide to help people
living with NASH,” said Martin Holst Lange, Senior Vice President,
Global Development at Novo Nordisk. “We are now carefully
evaluating next steps together based on a thorough assessment of
data.”
The companies are also presenting preclinical data supporting
the development of combination approaches in NASH. In the
preclinical trial, semaglutide alone and in combination with
cilofexor and/or GS-834356 (an analog of firsocostat) were
administered daily for 12 weeks in a murine model of diet-induced
NASH (n=15-16/group). The results demonstrated that while
semaglutide significantly improved NASH and fibrosis-related
endpoints, the addition of either cilofexor or the firsocostat
analog further improved liver fat reduction. The combination of all
three agents had the greatest impact on changes in the NAFLD
Activity Score (NAS).
The safety and efficacy of firsocostat, GS-834356 and cilofexor
have not been established. Firsocostat, GS-834356 and cilofexor are
investigational compounds and are not approved by the FDA or any
other regulatory authority. Semaglutide has not been approved by
the FDA or any other regulatory authority for the treatment of
people living with NASH, but has been approved for the treatment of
type 2 diabetes.
About NASH
NASH is a chronic and progressive liver disease characterized by
fat accumulation and inflammation in the liver, which can lead to
scarring, or fibrosis, that impairs liver function. The risk of
progression to advanced liver disease, including liver
decompensation (loss of liver function) and liver cancer, is higher
in people with NASH than in the general population and NASH could
become the leading reason for liver transplants in most countries.
Currently, no pharmacotherapy is globally approved for the
treatment of NASH, and people with NASH are left with very few
management options.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City,
California.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in
1923 and headquartered in Denmark. Our purpose is to drive change
to defeat diabetes and other serious chronic diseases such as
obesity and rare blood and endocrine disorders. We do so by
pioneering scientific breakthroughs, expanding access to our
medicines and working to prevent and ultimately cure disease. Novo
Nordisk employs about 44,000 people in 80 countries and markets its
products in around 170 countries. For more information, visit
novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.
Gilead Forward-Looking Statement
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including the possibility of unfavorable results from ongoing and
additional clinical trials involving cilofexor, firsocostat and
GS-834356 and the possibility that Gilead may be unable to complete
one or more of such trials in the currently anticipated timelines
or at all. Further, it is possible that Gilead may make a strategic
decision to discontinue development of cilofexor, firsocostat and
GS-834356 and other investigational compounds, or that the parties
may make a strategic decision to discontinue their collaboration at
any time, and as a result, the compounds may never be successfully
commercialized. All statements other than statements of historical
fact are statements that could be deemed forward-looking
statements. These risks, uncertainties and other factors could
cause actual results to differ materially from those referred to in
the forward-looking statements. The reader is cautioned not to rely
on these forward-looking statements. These and other risks are
described in detail in Gilead’s Quarterly Report on Form 10-Q for
the quarter ended September 30, 2020, as filed with the U.S.
Securities and Exchange Commission. All forward-looking statements
are based on information currently available to Gilead, and Gilead
assumes no obligation to update any such forward-looking
statements.
Gilead and the Gilead logo are registered
trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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version on businesswire.com: https://www.businesswire.com/news/home/20201115005154/en/
GILEAD CONTACTS: Douglas Maffei, PhD, Investors +1 (650)
522-2739
Darcy Bowman, Media +353 (87) 382-6777
NOVO NORDISK CONTACTS: Daniel Muusmann Bohsen, Investors
+45 3075 2175
Mette Kruse Danielsen +45 3079 3883
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