Gilead Announces Investigational Long-Acting HIV-1 Capsid Inhibitor, Lenacapavir, Achieves Primary Endpoint in Phase 2/3 Stud...
November 18 2020 - 8:35AM
Business Wire
– CAPELLA Trial Results Support Further
Study of Lenacapavir in People with Multidrug Resistant HIV-1
Infection Who are Failing Current Treatment Regimen –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline
results from the Phase 2/3 CAPELLA trial evaluating the company’s
investigational, long-acting HIV-1 capsid inhibitor, lenacapavir,
in heavily treatment-experienced people with multidrug resistant
HIV-1 infection. The study found that 88% of participants receiving
lenacapavir (n=21/24) experienced at least a 0.5 log10 reduction in
HIV-1 viral load by the end of 14 days of functional monotherapy as
compared with 17% of those receiving placebo (n=2/12).
“Treatment options that address the complex needs of heavily
treatment-experienced people living with multidrug resistant HIV
remain a significant unmet need. Lenacapavir, a novel
investigational capsid inhibitor that is being evaluated to be
administered subcutaneously every six months, represents a
potential substantial advance in the field of HIV treatment,” noted
Diana Brainard, MD, Senior Vice President and Virology Therapeutic
Area Head, Gilead Sciences. “We look forward to sharing data from
longer-term follow-up of CAPELLA study participants next year and
submitting these data for regulatory approval.”
Lenacapavir is being developed as a component of a long-acting
regimen in combination with other antiretroviral agents for the
treatment of HIV-1 infection. If approved, lenacapavir would be the
first HIV capsid inhibitor available for the treatment of HIV-1
infection. 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
multidrug resistance in combination with other antiretroviral
drugs.
In CAPELLA, 36 adults with multi-class HIV drug resistance and a
detectable viral load while on a failing regimen were randomized
2:1 to receive oral lenacapavir or placebo for 14 days, in addition
to continuing their failing regimen (functional monotherapy). Of
the 24 people randomized to the lenacapavir group, the median
baseline viral load was 4.2 log10 copies/mL and 67% had a CD4 count
of less than 200 cells/uL. A statistically significant greater
proportion of participants receiving lenacapavir met the primary
endpoint of a viral load reduction of at least 0.5 log10 copies/mL
from baseline compared with those receiving placebo at the end of
the 14-day functional monotherapy period (88% vs. 17%,
p<0.0001). Additionally, the lenacapavir group achieved a
statistically significant greater mean change in viral load versus
the placebo group (-1.93 log10 copies/mL vs. -0.29 log10 copies/mL,
p<0.0001).
Lenacapavir was generally safe and well-tolerated, with no
serious adverse events related to study drug observed and no study
drug discontinuations for any reason through the 14-day period,
including no discontinuations due to adverse events. The most
common adverse events observed in this portion of the study include
injection site swelling (21%) and injection site nodules (17%), the
majority of which were Grade 1 or 2 in severity.
“There is an urgent and critical need for innovative treatment
options for people living with HIV who have limited treatment
options and are not able to maintain virologic suppression on their
current therapy, whether from challenges adhering to a complex
regimen or HIV mutations that cause drug resistance,” said Edwin
DeJesus, MD, FACP, FIDSA, Medical Director, Orlando Immunology
Center. “The initial CAPELLA trial results demonstrate that
lenacapavir led to a rapid decline in viral load in heavily
treatment-experienced people with multidrug resistance living with
HIV. This clinical response could potentially have an important
impact on individual patients and public health.”
Additional data from the study will be presented at a future
scientific conference.
Following the 14-day functional monotherapy period of the study,
all participants are offered open-label lenacapavir added to an
optimized background regimen. This ongoing maintenance period of
the study is evaluating the subcutaneous administration of
lenacapavir every six months as well as the safety and efficacy of
lenacapavir in addition to an optimized background regimen at Weeks
26 and 52.
Lenacapavir is an investigational compound and is not approved
by any regulatory authority for any use and its safety and efficacy
are not known. There is no cure for HIV or AIDS.
About Lenacapavir
Lenacapavir acts in a novel way compared with currently
available antiretroviral agents by interrupting the activity of HIV
capsid, a protein that surrounds and protects the virus’ genetic
material and essential enzymes. In in vitro studies, lenacapavir
interrupts multiple distinct stages of the viral lifecycle,
potentially preventing the virus from becoming infectious and
gaining access to uninfected cells.
The safety, efficacy and dosing of lenacapavir are being
evaluated in multiple ongoing clinical studies. Data presented at
AIDS 2020 from the ongoing Phase 1 study support subcutaneous every
six-month administration of lenacapavir for both HIV treatment and
prevention studies. During IDWeek 2020, the company announced the
addition of a new study arm to the Women’s HIV Prevention Study
evaluating the use of lenacapavir as an injectable PrEP option
administered every six months. An additional lenacapavir for PrEP
study in men who have sex with men and persons of trans experience
is planned, with a projected trial initiation date of mid-late
2021.
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.
For more than 30 years, Gilead has been a leading innovator in
the field of HIV, driving advances in treatment, prevention,
testing and linkage to care, and cure research. Today, it’s
estimated that more than 12 million people living with HIV globally
receive antiretroviral therapy provided by Gilead or one of the
company’s manufacturing partners.
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 lenacapavir, and the
possibility that Gilead may be unable to complete one or more of
such trials on the currently anticipated timelines or at all. In
addition, it is possible that Gilead may make a strategic decision
to discontinue development of lenacapavir, or that FDA and other
regulatory agencies may not approve lenacapavir, and any marketing
approvals, if granted, may have significant limitations on its use.
As a result, lenacapavir 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 trademarks of
Gilead Sciences, Inc. or its related companies. 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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Douglas Maffei, PhD, Investors (650) 522-2739
Brian Plummer, Media (202) 309-5207
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