– Interim Phase 2b and Phase 3 Data Are
Consistent with Previous Results and Reinforce the Clinical Profile
of Hepcludex in Adults with Chronic HDV and Compensated Liver
Disease –
Gilead Sciences, Inc. (Nasdaq: GILD) today
announced interim results from the Phase 2b and Phase 3 clinical
trials evaluating the first-in-class entry inhibitor
Hepcludex® (bulevirtide) for the treatment of chronic
hepatitis delta virus (HDV). Findings from the Phase 3 study
support the safety and efficacy profile of bulevirtide 2 mg once
daily and are being presented today as a late-breaker in the
International Liver Congress™ (ILC) 2021 Official Press Program.
Results from the Phase 2b trial show that treatment with
bulevirtide alone or in combination with peginterferon alfa-2a, is
associated with a significant HDV RNA decline and improvements in
biochemical disease activity at Week 24.
The Phase 3 data will be included in the filing of bulevirtide
to the U.S. Food and Drug Administration (FDA) later this year.
Bulevirtide has been granted Breakthrough Therapy Designation and
Orphan Drug status by the FDA. Hepcludex has been granted
Conditional Marketing Authorization by the European Commission and
PRIority MEdicines (PRIME) scheme eligibility by the European
Medicines Agency as the first approved treatment in Europe for
adults with chronic HDV and compensated liver disease.
“These data represent meaningful progress as we work to address
the significant unmet needs of people living with HDV. This
infection presents a public health concern due to its rapid
progression, leading to complications including cirrhosis, hepatic
decompensation and an increased risk of liver cancer and death,”
said Tarik Asselah, Professor of Hepatology at Hôpital Beaujon,
Clichy, and at the University Paris, and Head of Viral Hepatitis
Team at INSERM UMR1149, France. “The data presented at ILC support
the safety and efficacy of bulevirtide in adults with HDV and
confirm the importance of this therapeutic option for people living
with chronic HDV.”
Interim results from the Phase 3 MYR301 study indicate that
after 24 weeks, the proportion of people with HDV achieving the
combined virological and biochemical response was 36.7% with
bulevirtide 2 mg, 28% in participants receiving bulevirtide 10 mg
and 0% in participants currently under observation who have not
received antiviral treatment at this stage of the study. Treatment
for 24 weeks with bulevirtide 2 mg or 10 mg had a superior response
(p<0.001) to the no treatment group, with bulevirtide 2 mg for
24 weeks having a numerically higher response rate compared with
bulevirtide 10 mg. Additionally, rapid ALT reduction and
normalization were observed in >50% of patients in the
bulevirtide 2 mg group compared with the bulevirtide 10 mg or no
treatment groups. These results reinforce the efficacy of
bulevirtide for the treatment of HDV. The safety profile of
bulevirtide at 24 weeks from these interim results is consistent
with prior reports, and no serious adverse events (AEs),
symptomatic elevations in bile salts or AEs leading to
discontinuation related to bulevirtide were reported.
Data from the Phase 2b MYR204 study assessing the safety and
efficacy of bulevirtide monotherapy or in combination with
peginterferon alfa-2a, in people living with HDV will also be
presented in an oral session on June 26. The study evaluating 175
people with chronic HDV randomly allocated people across four
groups: peginterferon alfa-2a; bulevirtide 2 mg plus peginterferon
alfa-2a; bulevirtide 10 mg plus peginterferon alfa-2a; and
bulevirtide 10 mg. The proportion of participants achieving a
combined response after 24 weeks of treatment was higher in those
treated with bulevirtide, with the highest response rate seen in
the monotherapy group. Treatment with bulevirtide, both as
monotherapy or in combination with peginterferon alfa-2a, was
well-tolerated, with mostly mild or moderate AEs and no reported
serious AEs or AEs leading to discontinuation of bulevirtide. The
European Commission granted Hepcludex 2 mg Conditional Marketing
Authorization; all other dosing and combinations are
investigational.
“HDV is the most serious form of chronic viral hepatitis and is
associated with rapid progression of serious complications
including fibrosis, cirrhosis and liver cancer. Currently, there
are very limited treatment options, and people living with HDV
typically have a poor prognosis. These data add to the growing body
of evidence demonstrating the potential role for bulevirtide in the
treatment of HDV,” said Merdad Parsey, MD, PhD, Chief Medical
Officer, Gilead Sciences. “We look forward to working closely with
global regulators with the goal of bringing bulevirtide to more
people living with HDV as quickly as possible.”
Bulevirtide is an investigational agent in the United States and
outside of the European Economic Area; in these regions, health
authorities have not established the safety and efficacy of
bulevirtide.
About MYR301 MYR301 is an
ongoing Phase 3 clinical trial evaluating the long-term efficacy
and safety of bulevirtide in 150 people living with chronic HDV
randomly allocated to treatment with bulevirtide 2 mg once daily
(n=49), at 10 mg (n=50) once daily or no antiviral treatment
(delayed treatment, n=51). Primary efficacy and safety data will be
assessed at Week 48. After Week 48, participants in the delayed
treatment group of the study will be switched to bulevirtide 10 mg
once daily for an additional 96 weeks. The total duration of
treatment across all groups in the study is 144 weeks. The primary
endpoint, combined response, is defined as an undetectable HDV RNA
(<LoD) or ≥2log10 IU/ml decline from baseline and ALT
normalization at week 48. Secondary endpoints at week 48 include
undetectable HDV RNA and a change from baseline in liver stiffness
measured by elastography.
About HDV Chronic hepatitis
delta virus (HDV) is the most severe form of viral hepatitis and
can have mortality rates as high as 50% within five years in
cirrhotic patients. HDV occurs only as a co-infection in
individuals who have hepatitis B virus (HBV). It is estimated that
at least 12 million people worldwide are currently co-infected with
HDV and HBV. HDV co-infection is associated with a faster
progression to liver fibrosis, cirrhosis, hepatic decompensation
and an increased risk of liver cancer and death. In the United
States and Europe, there are approximately 230,000 people living
with HDV; however, it remains underdiagnosed globally.
About Gilead Sciences in Liver
Disease For more than 20 years, Gilead has sought to
address some of the biggest challenges in liver disease. The
company has transformed the trajectory of many liver diseases
through a relentless pursuit of innovation and pioneering access
programs to bring meaningful therapies to people around the world.
More work is required, and Gilead is committed to advancing
innovative therapeutics to address the most pressing unmet needs in
liver disease and overcoming barriers to better care.
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
and cancer. 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, including those involving Hepcludex; the possibility of
unfavorable results from ongoing or additional clinical trials or
studies, including those involving Hepcludex; the possibility that
Gilead may make a strategic decision to discontinue development of
bulevirtide and other investigational compounds and as a result,
the compounds may never be successfully commercialized; Gilead’s
ability to receive regulatory approvals in a timely manner or at
all, including FDA or EMA approval of Hepcludex, and the risk that
any such approvals 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, 2021, 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 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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Jacquie Ross, Investors (650) 358-1054 Rhiannon Bid, Media
(Europe) +44 7824 530 487 Nat Sillin, Media (U.S.) (650)
866-9374
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