– If Approved, Lenacapavir Would be
the First Capsid Inhibitor and the Only HIV-1 Treatment Option
Administered Every 6 Months –
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the
company completed submission of a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) seeking approval of
lenacapavir, an investigational, long-acting HIV-1 capsid
inhibitor, for the treatment of HIV-1 infection in heavily
treatment-experienced (HTE) people with multi-drug resistant (MDR)
HIV-1 infection.
The submission is supported by data from the Phase 2/3 CAPELLA
trial, which evaluated the safety and efficacy of lenacapavir
administered subcutaneously every six months in combination with an
optimized antiretroviral background regimen. Key data on
lenacapavir will be presented during the 11th International AIDS
Society (IAS) Conference on HIV Science in July 2021.
In May 2019, the FDA granted Breakthrough Therapy Designation
for the development of lenacapavir for the treatment of HIV-1
infection in heavily treatment-experienced patients with multi-drug
resistance in combination with other antiretroviral drugs.
Lenacapavir, which is being studied as an every-six-month
subcutaneous injection, is a potential first-in-class capsid
inhibitor for the treatment of HIV-1 infection without overlapping
resistance with any currently approved antiretroviral therapy
(ART).
“Lenacapavir is an important breakthrough innovation with the
potential to be transformative for people living with multi-drug
resistant HIV who have very limited treatment options,” said Merdad
Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “The
filing moves us one step closer to providing an innovative
treatment option that helps to address barriers to achieving viral
suppression and meet the unmet needs of people living with
multi-drug resistant HIV.”
Lenacapavir is being developed in combination with other
antiretroviral agents for the treatment of HIV-1 infection in
adults and pediatric patients weighing at least 35 kg with MDR
HIV-1 infection who are currently on a failing antiretroviral
treatment regimen due to resistance, intolerance or safety
considerations. Lenacapavir is designed to inhibit HIV-1
replication by interfering with multiple, essential steps of the
viral lifecycle, including capsid-mediated uptake of HIV-1 proviral
DNA, virus assembly and release, and capsid core formation.
Gilead plans to submit marketing authorization applications for
lenacapavir to the European Medicines Agency and other global
agencies in the coming months.
Lenacapavir is an investigational compound and is not approved
by any regulatory authority for any use and its safety and efficacy
are not established. There is no cure for HIV or AIDS.
About CAPELLA
(NCT04150068)
CAPELLA is a Phase 2/3 double-blinded, placebo-controlled global
multicenter study designed to evaluate the antiviral activity of
Gilead’s investigational, long-acting HIV-1 capsid inhibitor
lenacapavir administered every 6 months as a subcutaneous injection
in HTE people with MDR HIV-1 infection. CAPELLA includes men and
women living with HIV-1 and is being conducted at research centers
in North America, Europe and Asia.
In CAPELLA, 36 participants with multi-class HIV-1 drug
resistance and a detectable viral load while on a failing regimen
were randomly allocated to receive oral lenacapavir or placebo for
14 days, in addition to continuing their failing regimen
(functional monotherapy). An additional 36 participants were
enrolled in a separate treatment cohort. The primary endpoint was
the proportion of participants randomly allocated to receive oral
lenacapavir or placebo for 14 days, in addition to continuing their
failing regimen, achieving ≥ 0.5 log10 copies/mL reduction from
baseline in HIV-1 RNA at the end of the functional monotherapy
period.
The study achieved its primary endpoint by demonstrating that a
significantly higher proportion of participants randomly allocated
to receive lenacapavir achieved a clinically meaningful viral load
reduction of at least 0.5 log10 copies/mL from baseline compared
with those receiving placebo during the 14-day functional
monotherapy period (88% vs. 17%, p<0.0001). These data were
previously presented at the virtual 28th Conference on Retroviruses
and Opportunistic Infections (virtual CROI 2021). Those who
received lenacapavir (n=24) achieved statistically significantly
greater mean decrease in viral load than those who received placebo
(n=12) during the functional monotherapy period (-1.93 log10
copies/mL vs. -0.29 log10 copies/mL, p<0.0001). Lenacapavir was
generally well-tolerated, with no serious adverse events related to
study drug observed and no study drug discontinuations through the
14-day period, including no discontinuations due to adverse events.
The most common adverse events observed were injection site
reactions.
Following the 14-day functional monotherapy period, participants
who were randomly allocated to receive lenacapavir or placebo, in
addition to continuing their failing regimen, started open-label
lenacapavir and an optimized background regimen, while those
enrolled in a separate treatment cohort received open-label
lenacapavir and an optimized background regimen on Day 1. This
ongoing maintenance period of the study is evaluating the
additional trial endpoints of safety and efficacy of subcutaneous
lenacapavir administered every six months in combination with an
optimized background regimen. The trial data for the first
six-month period (Week 26) have been submitted to the FDA as part
of the NDA filing, and will be presented at an upcoming
conference.
For further information, please see
https://clinicaltrials.gov/ct2/show/NCT04150068.
About Lenacapavir
Lenacapavir is a potential first-in-class, 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 and has no known cross resistance to other
existing drug classes.
The safety, efficacy and dosing of lenacapavir are being
evaluated in multiple ongoing clinical studies. Data presented at
AIDS 2020 from a completed Phase 1 study support further evaluation
of lenacapavir administered subcutaneously every six-month for both
HIV-1 treatment and prevention. During IDWeek 2020, the company
announced plans to evaluate the use of lenacapavir as an injectable
PrEP option administered every six months among cisgender women,
men who have sex with men and persons of trans experience. The
prevention trials have projected initiation dates in 2021.
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 eleven HIV
medications, including the first single tablet regimen to treat HIV
and the first once-daily oral antiretroviral tablet 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.
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 lenacapavir; the possibility
of unfavorable results from ongoing or additional clinical trials
or studies, including those involving lenacapavir; Gilead’s ability
to receive regulatory approvals in a timely manner or at all,
including FDA, European Medicines Agency or other regulatory
approval of lenacapavir, and the risk that any such approvals may
be subject to significant limitations on use; the possibility that
Gilead may make a strategic decision to discontinue development of
lenacapavir and that, 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 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.
GILEAD and the GILEAD logo are trademarks of
Gilead Sciences, Inc. All other trademarks are the property of
their respective owners.
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/20210628005788/en/
Jacquie Ross, Investors (650) 358-1054
Brian Plummer, Media (202) 309-5207
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