– This Clinical Study is the First from
Merck and Gilead’s Collaboration to Develop Potential Long-Acting
HIV Treatment Options –
Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK),
known as MSD outside the United States and Canada, today announced
the start of a Phase 2 clinical study evaluating an investigational
once-weekly oral combination treatment regimen of islatravir and
lenacapavir in people living with HIV who are virologically
suppressed on antiretroviral therapy.
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“Partnerships and collaborations are critical to continuing the
tremendous progress that has been made toward ending the HIV
epidemic,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical
Development, Gilead Sciences. “This innovative research
collaboration builds on the efforts of both companies to help make
the end of the epidemic a reality through continued scientific
advances in HIV. Initiating the trial represents an important step
forward toward our goal of offering long-acting options that can
help address the differentiated needs and preferences of the
diverse range of people living with HIV.”
Through the collaboration between Merck and Gilead, announced in
March 2021, the companies seek to build on their legacies of
transforming HIV care by focusing on long-acting therapies, which
may represent a meaningful innovation in HIV drug development.
“The initiation of this study is key to further understanding
the potential of islatravir and lenacapavir in combination for the
treatment of HIV-1, and demonstrates Merck and Gilead’s shared
commitment to address the unmet needs of people living with HIV and
to contribute to global efforts to end the pandemic,” said Dr. Joan
Butterton, vice president, global clinical development, infectious
diseases, Merck Research Laboratories.
Both islatravir and lenacapavir have long half-lives and have
demonstrated activity at low dosages in independent clinical
studies, which support the development as an investigational
combination regimen with long-acting formulations, both oral and
injectable. While daily, single tablet oral regimens are available
for people living with HIV, oral or injectable regimen options that
allow for less frequent dosing have the potential to address
preference considerations, as well as issues associated with
stigma, adherence, and privacy.
The Phase 2 study is designed to evaluate the safety and
antiviral effect of an oral weekly regimen of Merck’s
investigational nucleoside reverse transcriptase translocation
inhibitor, islatravir, in combination with Gilead’s investigational
capsid inhibitor, lenacapavir. The primary endpoint is the
proportion of study participants with HIV-1 RNA viral load ≥ 50
c/mL at Week 24.
Lenacapavir and islatravir, alone and in combination, are
investigational and not approved anywhere globally. Their safety
and efficacy have not yet been established.
There is currently no cure for HIV or AIDS.
About NCT05052996
This Phase 2, open-label, active-controlled, multicenter study
is designed to evaluate the safety and antiviral effect of an oral
weekly regimen of islatravir in combination with lenacapavir in
virologically suppressed people with HIV. Participants age 18 years
and older will be enrolled in this study, which is being conducted
at 25 sites in the United States.
In the trial, 75 participants who meet all eligibility criteria
will be randomly allocated in a 2:1 ratio to receive oral weekly
islatravir (20 mg) administered with oral lenacapavir (300 mg) on
day 8 following a loading dose of islatravir (40 mg) and
lenacapavir (600 mg) on days 1 and 2 or oral daily B/F/TAF
(bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg
tablets). Participants will receive study drugs for 48 weeks.
Following completion of the Week 48 visit, participants in
Treatment Group 1 will continue to receive an oral weekly regimen
of islatravir in combination with oral lenacapavir and be evaluated
every 12 weeks. Participants in Treatment Group 2 will switch from
daily oral B/F/TAF tablets to an oral weekly regimen of islatravir
in combination with oral lenacapavir (starting with the loading
doses over 2 days) and continue the study with visits every 12
weeks thereafter.
For further information, please see:
https://clinicaltrials.gov/ct2/show/NCT05052996
About Lenacapavir
Lenacapavir is Gilead’s potential first-in-class,
investigational long-acting HIV-1 capsid inhibitor in development
for the treatment and prevention of HIV-1 infection. Lenacapavir's
multi-stage mechanism of action is distinguishable from currently
approved classes of antiviral agents and is designed to provide a
new avenue for the development of long-acting therapy options for
people living with or at risk for HIV-1. While most antivirals act
on just one stage of viral replication, lenacapavir is designed to
inhibit HIV-1 at multiple stages of its lifecycle.
About Islatravir (MK-8591)
Islatravir (MK-8591) is Merck’s investigational nucleoside
reverse transcriptase translocation inhibitor under evaluation in
more than 10 clinical trials. For treatment, islatravir is being
evaluated in combination with other antiretrovirals, including the
ILLUMINATE clinical trials program for a once-daily regimen. In the
IMPOWER clinical trials, islatravir is also being studied for
pre-exposure prophylaxis (PrEP) of HIV-1 infection as a single
agent across a variety of formulations, including an oral
once-monthly regimen. An overview of the islatravir treatment and
prevention development program is available here. In 2012, Merck
licensed islatravir (4’-ethynyl-2-fluoro-2’-deoxyadenosine or EFdA)
from the Yamasa Corporation based in Choshi, Japan.
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.
For more than 30 years, Gilead has been a leading innovator in
the field of HIV, driving advances in treatment, prevention and
cure research. Gilead researchers have developed 11 HIV
medications, including the first single tablet regimen to treat HIV
and the first antiretroviral for pre-exposure prophylaxis (PrEP) to
reduce the risk of acquiring HIV infection. These advances in
medical research have helped to transform HIV into a preventable,
chronic condition for millions of people.
Gilead is committed to continued scientific innovation to
provide solutions for the evolving needs of people affected by HIV
around the world. Through partnerships and collaborations, the
company also aims to improve education, expand access and address
barriers to care, with the goal of ending the HIV epidemic for
everyone, everywhere.
Gilead operates in more than 35 countries worldwide, with
headquarters in Foster City, California.
About Merck
For more than 130 years, Merck, known as MSD outside the United
States and Canada, has been inventing for life, bringing forward
medicines and vaccines for many of the world’s most challenging
diseases in pursuit of our mission to save and improve lives. We
demonstrate our commitment to patients and population health by
increasing access to health care through far-reaching policies,
programs and partnerships. Today, Merck continues to be at the
forefront of research to prevent and treat diseases that threaten
people and animals – including cancer, infectious diseases such as
HIV and Ebola, and emerging animal diseases – as we aspire to be
the premier research-intensive biopharmaceutical company in the
world. For more information, visit www.merck.com and connect with
us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
For more than 35 years, Merck has been committed to scientific
research and discovery (R&D) in HIV. Today, we are developing a
series of antiviral options designed to help people manage HIV and
protect people from HIV, with the goal of reducing the growing
burden of infection worldwide. We remain committed to working
hand-in-hand with our partners in the global HIV community to
address the complex challenges that hinder continued progress
toward ending the epidemic.
Gilead 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 the risk that Gilead may not realize any anticipated
benefits from this collaboration; difficulties or unanticipated
expenses in connection with the collaboration and the potential
effects on Gilead’s revenues and earnings; the ability of the
companies to initiate and complete clinical trials in the
anticipated timelines or at all, including those involving
lenacapavir, the combinations of lenacapavir and islatravir and
other investigational oral integrase inhibitors; the possibility of
unfavorable results from ongoing and additional clinical trials,
including those involving lenacapavir, the combinations of
lenacapavir and islatravir and other investigational oral integrase
inhibitors; the ability of the companies to successfully co-develop
and co-commercialize long-acting HIV treatments; uncertainties
relating to regulatory applications and related filing and approval
timelines, including the risk that regulatory authorities may not
approve such applications in the anticipated timelines or at all,
and any marketing approvals, if granted, may have significant
limitations on its use; the possibility that the companies may make
a strategic decision to terminate this collaboration; the
possibility that Gilead may make a strategic decision to
discontinue development of lenacapavir and as a result, lenacapavir
may never be successfully commercialized; 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 June 30, 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.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of the global outbreak of novel coronavirus disease
(COVID-19); the impact of pharmaceutical industry regulation and
health care legislation in the United States and internationally;
global trends toward health care cost containment; technological
advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining
regulatory approval; the company’s ability to accurately predict
future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign
risk; dependence on the effectiveness of the company’s patents and
other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2020
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
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Gilead Brian Plummer, Media +1
(202) 309-5207
Jacquie Ross, Investors + 1 (650) 358-1054
Merck Sienna Choi, Media +1 (908)
873-4311
Peter Dannenbaum, Investors +1 (908) 740-1037
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