– Key Findings from PBC, HDV, HCV,
HBV and MASH/Fibrosis Studies Affirm Commitment to Drive
Life-changing Science in Liver Disease –
Gilead Sciences, Inc. (Nasdaq:GILD) today announced new research
to be presented at the European Association for the Study of the
Liver (EASL) Congress, June 5-8, 2024 in Milan, Italy. Key findings
from more than 25 abstracts will include:
- Interim results for two years from the ASSURE study which
evaluate the long-term efficacy and safety profile of
investigational seladelpar for the treatment of primary biliary
cholangitis (PBC);
- Results of a pooled analysis, showcasing the effects of
tenofovir-based antiviral therapy in reducing long-term incidence
of primary liver cancer in people living with chronic hepatitis B
(HBV);
- Final results of the Phase 2b MYR204 study evaluating the
efficacy and safety of Hepcludex® (bulevirtide) in combination with
pegylated interferon alfa-2a (PegIFN) in patients with compensated
chronic hepatitis delta virus (HDV); and
- A late breaker presentation on the final results from the
pivotal MYR301 Phase 3 study evaluating the efficacy and safety of
bulevirtide as monotherapy.
“These data underline Gilead’s commitment to drive life-changing
science and create healthier futures for people living with liver
disease. We look forward to presenting our latest research at EASL,
as we strive to deliver novel medicines to populations with high
unmet medical need,” said Frank Duff, MD, Senior Vice President,
Virology Therapeutic Area Head, Gilead Sciences. “The breadth of
our data being presented across viral and inflammatory liver
diseases, speaks to our commitment to driving positive change at
every step of a person’s journey. Transforming lives goes beyond
treatment, and our research, innovation and partnerships span
initial awareness and education, through to screening, diagnosis,
path to care and ongoing management to address current unmet
needs.”
To drive efforts in supporting the World Health Organization’s
(WHO) goal to eliminate viral hepatitis as a public health threat
by 2030, Gilead will also present real-world data in hepatitis C
(HCV) and launch a national HCV awareness program in Italy to raise
awareness of the disease. In collaboration with EASL, Gilead will
launch “Epatite C Mettiamoci un Punto” (Hepatitis C Let’s Put a
Stop to it) in Milan to raise awareness about the disease and
encourage people to get tested for HCV through EASL’s “Love Your
Liver” Campaign.
Advancing Treatment options in PBC
New data demonstrating the long-term efficacy and safety profile
of investigational seladelpar for the treatment of primary biliary
cholangitis (PBC) will be presented at EASL. These include the
first interim data from the Phase 3 open-label ASSURE study that
includes people who received a second year of seladelpar treatment
following their initial participation in the Phase 3 RESPONSE
study. The study also includes patients with insufficient response
to first-line PBC treatment, ursodeoxycholic acid (UDCA). These
data evaluate the composite biochemical response (alkaline
phosphatase (ALP) < 1.67x upper limit of normal (ULN), ALP
decrease ≥ 15%, and total bilirubin ≤ ULN) and ALP normalization,
as well as pruritus for seladelpar in the treatment of PBC which is
a rare, chronic, cholestatic liver disease mainly affecting women
(1 in 1,000 women over the age of 40 or about 130,000 total people
in the U.S.) that impairs liver function and quality of life. The
most common early symptoms of PBC are pruritus (itching) and
fatigue, which can be debilitating for some patients. Progression
of PBC is associated with an increased risk of liver-related
mortality.
Key Findings in HDV
At the EASL Congress, Gilead will present 13 abstracts in HDV,
including the Week 144 (48 Weeks off-treatment) results of the
Phase 2b MYR204 study of bulevirtide with or without peginterferon
alfa-2a (PegIFN) in people with chronic HDV and compensated liver
disease (GS-002), and results from the pivotal Phase 3 MYR301 study
assessing the efficacy and safety of bulevirtide as monotherapy as
a late-breaker presentation (LB-309).
Further highlighting Gilead as a leader in HDV research, a
sub-analysis of the MYR204 study (OS-122) evaluating intrahepatic
virological outcomes 24 Weeks off-treatment will be presented. A
pooled analysis of the MYR203, MYR204 and MYR301 studies (TOP-400)
discussing the impact of nucleos(t)ide analogues alongside
bulevirtide 48 Weeks off-treatment will also be shared as an oral
presentation. These data evaluate the efficacy profile of
bulevirtide for people living with HDV, which is considered the
most severe form of viral hepatitis due to rapid disease
progression towards liver failure, liver cancer and liver-related
death.
Key Abstracts at EASL 2024:
ID
Abstract Title
PBC
OS-019
Efficacy and safety of seladelpar in
patients with primary biliary cholangitis and compensated liver
cirrhosis in the open-label, long-term ASSURE safety study: interim
results
THU-098
Appraising gain of an extended 2-year
placebo-controlled trial in primary biliary cholangitis: challenges
for evaluating clinical outcomes
SAT-175
PPAR-delta activation with seladelpar
regulates cholangiocyte inflammation
THU-119
Seladelpar treatment increases fatty acid
beta-oxidation and serum carnitine levels in patients with primary
biliary cholangitis consistent with increased expression of the
carnitine transporter OCTN2 and the mitochondrial carnitine
shuttle
SAT-177
Assessment of PPAR-delta target engagement
in mouse liver assessed by single nuclei sequencing following a
single oral dose of seladelpar
LB-283
Long-term efficacy and safety of
open-label seladelpar treatment in patients with primary biliary
cholangitis (PBC): interim results for 2 years from the ASSURE
study
HDV
GS-002
48-week off-therapy efficacy and safety of
bulevirtide in combination with pegylated interferon alfa-2a in
patients with chronic hepatitis delta: Final results from
MYR204
LB-309
Efficacy and safety of 144 weeks of
bulevirtide 2 mg or 10 mg monotherapy from the ongoing Phase 3
study, MYR301
TOP-400
Impact of bulevirtide given with or
without nucleos(t)ide analogues on 48-week virologic outcomes in
patients with chronic hepatitis delta virus infection
WED-395
Undetectable hepatitis delta virus RNA at
the end of treatment with bulevirtide and pegylated interferon
alpha-2a is an important predictor of 48 weeks sustained virologic
response in chronic hepatitis delta
OS-122
Bulevirtide in combination with pegylated
interferon alfa-2a shows a sustained off-treatment response in the
liver
FRI-435
Serological and nucleic acid testing
laboratory screening rates for hepatitis delta virus among adult
patients in the United States
HCV
THU-374
Description of age, sex, and
characteristics of hepatitis C patients in the SVR10K study: a
real-world SOF/VEL analysis performed across five global
regions
WED-498
Impact of direct acting antiviral market
access policy barriers and restrictions for Hepatitis C patients: a
database analysis of claims from states with and without Medicaid
restrictions
WED-447
Age at incident cirrhosis in individuals
with hepatitis C virus infection: a US administrative claims
analysis
HBV
WED-397
Tenofovir-based antiviral therapy reduces
long-term incidence of hepatocellular carcinoma in chronic
hepatitis B patients
FRI-390
Off-treatment outcomes after discontinuing
tenofovir-based treatment in hepatitis B e antigen-positive and
hepatitis B e antigen-negative patients with chronic hepatitis B
virus
MASH/Fibrosis
TOP-264
Paired assessment of Enhanced Liver
Fibrosis (ELF) and Fibrosis-4 (FIB-4) scores is associated with an
elevated risk of liver-related clinical events in patients with
advanced fibrosis due to metabolic dysfunction-associated
steatohepatitis (MASH)
For more information, including a complete list of abstract
titles being presented at the meeting, please visit the EASL
website.
In July 2023, the European Commission (EC) granted full
Marketing Authorization (MA) for bulevirtide 2 mg for the treatment
of adults with chronic HDV and compensated liver disease.
Bulevirtide was initially granted conditional MA from the EC in
July 2020 to provide access to people living with HDV urgent access
to treatment. Bulevirtide also received full MA in Great Britian in
August 2023 and in Switzerland in February 2024. In the U.S. and
outside of the European Economic Area, bulevirtide is an
investigational agent that is not approved for any use. In these
regions, health authorities have not established the safety and
efficacy of bulevirtide. Bulevirtide 10 mg is an investigational
product and has not been approved anywhere globally.
Seladelpar is an investigational compound and is not approved by
the U.S. Food and Drug Administration (FDA) or any other regulatory
authority; its safety and efficacy have not been established.
About PBC
PBC is a rare, chronic inflammatory liver disease primarily
affecting women (1 in 1,000 women over the age of 40 or about
130,000 total people in the US). PBC is characterized by impaired
bile flow (known as cholestasis) and the accumulation of toxic bile
acids in the liver, leading to inflammation and destruction of the
bile ducts within the liver and causing increased levels of ALP,
ALT, and GGT, enzymes found primarily in the liver, as well as
total bilirubin. The most common early symptoms of PBC are pruritus
(itching) and fatigue, which can be debilitating for some patients.
Progression of PBC is associated with an increased risk of
liver-related mortality.
About HDV
HDV is considered the most aggressive or severe form of viral
hepatitis, associated with more rapid progression towards
liver-related death and liver cancer in people with hepatitis B
(HBV). On average, HDV progresses to cirrhosis within 5 years and
to liver cancer within 10 years. Nearly 5% of people who have a
chronic infection with HBV are estimated to have HDV, equating to
12-15 million people worldwide. The prevalence of HDV infection is
largely underestimated due to lack of universal testing of
HBV-positive individuals for HDV.
About Gilead Sciences in Liver
Disease
For decades, Gilead has pioneered the way forward to improve the
lives of people living with liver disease around the world. We have
helped transform hepatitis C from a chronic condition into one that
can be cured for millions of people. For people living with
hepatitis B or D, our focus on advancing our medicines drives hope
that today’s research will turn into tomorrow’s cures. Beyond viral
hepatitis, we’re working to deliver advanced treatments for people
living with primary biliary cirrhosis (PBC). But our commitment
doesn’t stop there. Through our ground-breaking science and
collaborative partnerships, we strive to create healthier futures
for everyone living with liver disease. We are committed to a
future without liver disease.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis, COVID-19, cancer and inflammation. Gilead operates
in more than 35 countries worldwide, with headquarters in Foster
City, California.
Forward-Looking
Statements
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 Gilead’s ability to initiate, progress or complete
clinical trials or studies within currently anticipated timelines
or at all, and the possibility of unfavorable results from ongoing
or additional clinical trials or studies, including those involving
Hepcludex (bulevirtide) and seladelpar; uncertainties relating to
regulatory applications and related filing and approval timelines,
including the risk that the FDA and other regulatory authorities
may not approve bulevirtide for the treatment of HDV and/or
seladelpar for the treatment of PBC, and the risk that any such
approvals, if granted, may be subject to significant limitations on
use; and any assumptions underlying any of the foregoing. These and
other risks, uncertainties and factors are described in detail in
Gilead’s Quarterly Report on Form 10-Q for the quarter ended March
31, 2024, as filed with the U.S. Securities and Exchange
Commission. These risks, uncertainties and other factors could
cause actual results to differ materially from those referred to in
the forward-looking statements. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. The reader is cautioned that any such
forward-looking statements are not guarantees of future performance
and involve risks and uncertainties and is cautioned not to place
undue reliance on these forward-looking statements. All
forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation and disclaims
any intent to update any such forward-looking statements.
Hepcludex, 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/20240522704668/en/
Meaghan Smith, Media public_affairs@gilead.com
Jacquie Ross, Investors investor_relations@gilead.com
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