Gilead Sciences, Inc. (Nasdaq: GILD) today announced the
initiation of a Phase 2 clinical trial evaluating GS-7340 for the
treatment of HIV-1 infection in treatment-naïve adults. GS-7340 is
a novel prodrug of tenofovir, the active agent in Viread®
(tenofovir disoproxil fumarate). In previous studies, GS-7340 has
demonstrated the ability to provide greater antiviral efficacy at a
dose that is ten times lower than Viread.
“The advancement of GS-7340 into this Phase 2 study is an
important milestone in Gilead’s efforts to develop the next
generation of best-in-class therapies for HIV,” said Norbert
Bischofberger, PhD, Executive Vice President, Research and
Development and Chief Scientific Officer, Gilead Sciences. “Because
it can be used once-daily at one-tenth the dose of Viread, which is
a much lower dose compared to other currently available anti-HIV
compounds, GS-7340 could enable the development of a new range of
single-tablet regimens for HIV that optimize clinical efficacy,
safety and tolerability for patients.”
The Phase 2 study will evaluate GS-7340 as part of a once-daily,
co-formulated single-tablet regimen that will also contain the
boosting agent cobicistat, the integrase inhibitor elvitegravir,
and Emtriva® (emtricitabine). The GS-7340-containing single-tablet
regimen will be compared to Gilead’s Quad single-tablet regimen,
which contains Viread and Emtriva (as Truvada®), elvitegravir and
cobicistat, and is currently under review for marketing approval by
U.S. and European regulatory agencies.
Gilead plans to initiate a second Phase 2 trial for GS-7340
later in 2012 that will assess GS-7340 as part of another
single-tablet regimen containing cobicistat, Emtriva and Tibotec
Pharmaceuticals’ protease inhibitor Prezista® (darunavir). Gilead
announced an agreement with Tibotec to develop this single-tablet
regimen on November 15, 2011.
Viread was approved for HIV treatment in 2001 and has
accumulated more than 4.4 million patient years of clinical
experience to date.
About the GS-7340 Phase 2
Study
The Phase 2 study is a randomized, double-blind 48-week clinical
trial among HIV-1 infected adults with HIV RNA levels (viral load)
greater than or equal to 5,000 copies/mL and CD4 cell counts
greater than 50 cells/mm3. A total of 150 patients will be
randomized (2:1) to receive a once-daily tablet containing GS-7340
10 mg/cobicistat 150 mg/elvitegravir 150 mg/emtricitabine 200 mg
(n=100) or the Quad (tenofovir disoproxil fumarate 300
mg/cobicistat 150 mg/elvitegravir 150 mg/emtricitabine 200 mg)
(n=50). The HIV virus of participants must be sensitive to both
tenofovir and emtricitabine, prior use of antiretrovirals is not
allowed and participants must have adequate renal function (defined
as an estimated glomerular filtration rate of greater than or equal
to 70 mL/min, according to the Cockcroft-Gault formula).
The primary endpoint will be the proportion of patients with
viral load less than 50 copies/mL at 24 weeks of treatment as
determined by the FDA-defined snapshot analysis. Secondary
endpoints will include the proportion of patients who achieve viral
load of less than 50 copies/mL at 48 weeks of therapy, and change
from baseline in HIV-1 RNA and in CD4+ cell count to Weeks 24 and
48. After week 48, patients will continue to take their blinded
study drug until treatment assignments have been unblinded, at
which point all will be given the option to participate in an
open-label rollover extension and receive the GS-7340-based
single-tablet regimen.
Additional information about the study can be found at
www.clinicaltrials.gov.
About GS-7340
GS-7340 is a novel prodrug of tenofovir, the active agent in the
company's HIV drug Viread. Like Viread, GS-7340 is a nucleotide
reverse transcriptase inhibitor (NtRTI). Phase 2a dose-ranging
studies have identified a dose that is ten times lower than Viread
and provides greater antiviral efficacy. The smaller milligram size
of GS-7340 may enable the development of new fixed-dose
combinations and single-tablet regimens for HIV therapy that are
not feasible with Viread.
About Cobicistat
Cobicistat is a potent mechanism-based inhibitor of cytochrome
P450 3A (CYP3A), an enzyme that metabolizes drugs in the body.
Gilead is evaluating cobicistat in three separate pivotal Phase 3
studies, both as a stand-alone boosting agent for protease
inhibitors, as well as part of the Quad regimen. Gilead has
exclusive rights to develop cobicistat worldwide, except for Japan,
where JT is licensed to develop and commercialize the product.
About Elvitegravir
As an integrase inhibitor, elvitegravir interferes with HIV
replication by blocking the ability of the virus to integrate into
the genetic material of human cells. Elvitegravir was licensed by
Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms
of Gilead’s agreement with JT, Gilead has exclusive rights to
develop and commercialize elvitegravir in all countries of the
world, excluding Japan, where JT retains rights.
About Quad
The Quad is a single-tablet regimen that contains elvitegravir,
cobicistat, emtricitabine and tenofovir disoproxil fumarate. In
October 2011, Gilead submitted a New Drug Application to the U.S.
FDA for the Quad for the treatment of HIV among treatment-naïve
patients.
GS-7340, cobicistat, elvitegravir and the Quad are
investigational products and their safety and efficacy have not yet
been established.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of
unmet medical need. The company’s mission is to advance the care of
patients suffering from life-threatening diseases worldwide.
Headquartered in Foster City, California, Gilead has operations in
North America, Europe and Asia Pacific.
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 risks related to our ability to enroll patients in the
Phase 2 clinical trial of a single-tablet regimen containing
elvitegravir, cobicistat, emtricitabine and GS-7340, our ability to
initiate the Phase 2 trial of a single-tablet regiment containing
cobicistat, emtricitabine, darunavir and GS-7340, the possibility
of unfavorable results of this or other clinical trials involving
GS-7340, the need to modify or delay the clinical trials or to
perform additional trials and the risk of failing to obtain U.S.
Food and Drug Administration and other regulatory body approvals
for GS-7340 and single-tablet regimens containing GS-7340,
including the Quad. As a result, GS-7340 may never be successfully
commercialized. Further, we may make a strategic decision to
discontinue development of GS-7340 if, for example, we believe
commercialization will be difficult relative to other opportunities
in our pipeline. 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, 2011, 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.
U.S. full prescribing information for Viread is
available at www.Viread.com.U.S. full prescribing information for
Truvada is available at www.Truvada.com.U.S. full prescribing
information for Emtriva is available at www.GileadHIV.com.Viread,
Truvada and Emtriva are registered trademarks of Gilead Sciences,
Inc.
For more information on Gilead Sciences, please
visit the company's website at www.gilead.com or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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