Gilead Presents Proof-of-Concept Data for GS-6207, a First-in-Class Capsid Inhibitor, in People Living With HIV
July 22 2019 - 11:00AM
Business Wire
– Phase 1b Study Demonstrates Potent
Antiviral Efficacy Following a Single Subcutaneous Injection of
GS-6207, No Discontinuations Due to Adverse Events –
Gilead Sciences, Inc. (NASDAQ: GILD) today presented the first
clinical data in people living with HIV on GS-6207, an
investigational, novel, selective, first-in-class inhibitor of HIV
capsid function. The Phase 1b data demonstrate the first proof of
concept that HIV capsid inhibition can lead to significant declines
in viral load in vivo. In addition, Gilead presented preclinical
data demonstrating that resistance to GS-6207 in vitro did not lead
to resistance to other classes of drugs used in the treatment of
HIV. These data were presented at the 10th International AIDS
Society Conference on HIV Science (IAS 2019) in Mexico City.
GS-6207 is an investigational long-acting antiretroviral agent
that can be delivered subcutaneously. GS-6207 recently received
breakthrough therapy designation from the U.S. Food and Drug
Administration (FDA) as a potential therapy for heavily
treatment-experienced people living with multi-drug resistant HIV.
GS-6207 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. GS-6207 may interrupt multiple distinct stages
of the viral lifecycle, potentially preventing the virus from
becoming infectious and gaining access to uninfected cells.
“The data presented at IAS underscore our commitment to
scientific discovery, building on Gilead’s legacy of transformative
advances in HIV therapies,” said Diana Brainard, MD, Senior Vice
President, HIV and Emerging Viruses, Gilead Sciences. “GS-6207's
multi-stage mechanism of action profile is distinguishable from
currently approved classes of antiretroviral agents and may provide
a new avenue for the development of long-acting treatment regimens
for people living with HIV."
Studies on GS-6207 presented at IAS 2019 include:
Poster LBPEB13: Safety and antiviral activity over 10 days
following a single dose of subcutaneous GS-6207, a first-in-class,
long-acting HIV capsid inhibitor in people living with HIV
This ongoing Phase 1b trial randomized people living with HIV
with no prior capsid inhibitor treatment to receive a single
subcutaneous injection of GS-6207 (50 mg, 150 mg and 450 mg doses;
n=6 per dose) versus placebo (n=6). The primary endpoint was
maximum reduction of HIV-1 RNA through 10 days of treatment. In
each dose group, mean maximum reduction in HIV-1 RNA by day 10
ranged from 1.8 to 2.2 log10copies/mL, which were all significantly
greater compared with placebo (all p<0.0001). No participant
experienced a serious adverse event or discontinued due to adverse
events. The most common adverse events were mild to moderate
reactions at the injection site (63 percent; 15 of 24), all of
which were self-limiting.
“This study provides the first clinical evidence that HIV capsid
inhibition can lead to a significant decline in viral load and
supports further evaluation of GS-6207 as a component of an
effective antiretroviral regimen. In addition, a long-acting
regimen can help some people living with HIV by reducing the burden
of daily pill taking,” said Eric Daar, MD, Chief, Division of HIV
Medicine at Harbor-UCLA Medical Center and lead study author.
“These early trial results support advancing GS-6207 into the next
phase of clinical development to understand its role as part of
long-acting HIV therapy.”
Poster TUPEA075: In vitro resistance profile of GS-6207, a
first-in-class picomolar HIV capsid inhibitor in clinical
development as a novel long-acting antiretroviral agent
This in vitro study evaluated the emergence of resistance to
GS-6207 in HIV-infected cells for the first time. At subtherapeutic
concentrations, GS-6207 selected for L56I, Q67H, N74D/S or T107N
mutations in HIV capsid. Virus containing one or more of these
capsid mutations showed reduced susceptibility to GS-6207 but
remained fully susceptible to other antiretroviral classes.
GS-6207-selected variants occurred at highly conserved capsid
residues (94 to 100 percent) and were extremely rare (<1
percent) in viral isolates from treatment-naïve people living with
HIV. In vitro resistance to GS-6207 was commonly associated with
reduced infectivity and impaired replication capacity, highlighting
the importance of capsid in the viral replication cycle.
GS-6207 is an investigational therapy and is not approved by any
regulatory authority globally; its safety and efficacy have not
been established. There is no cure for HIV or AIDS.
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 nearly 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.
For more information on Gilead Sciences, please visit the
company’s website at www.gilead.com.
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 studies of GS-6207. 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 March 31, 2019, 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.
For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com, follow Gilead on
Twitter (@GileadSciences) or call Gilead Public Affairs at
1-800-GILEAD-5 or 1-650-574-3000.
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Sung Lee, Investors (650) 524-7792 Ryan McKeel, Media (650)
377-3548
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