Gilead Announces Data for Investigational, All-Oral, Pan-Genotypic Three-Drug Regimen of Sofosbuvir, GS-5816 & GS-9857 for Ch...
April 23 2015 - 1:00AM
Business Wire
-- Data Support Ongoing Trials Evaluating
Shortened Course of Therapy --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced
pre-clinical data and results from Phase 1 and Phase 2 studies
supporting the development of an investigational all-oral,
pan-genotypic regimen of Sovaldi® (sofosbuvir 400 mg/SOF), the
investigational NS5A inhibitor GS-5816 and GS-9857, an
investigational NS3/4A protease inhibitor. These data will be
presented at the 50th Annual Meeting of the European Association
for the Study of the Liver (The International Liver Congress™ 2015)
in Vienna, Austria.
In pre-clinical studies, GS-9857 demonstrated similarly potent
antiviral activity against HCV replicons of all tested genotypes
(1-6), as well as an improved resistance profile compared to other
HCV protease inhibitors (ePoster #P0899). In a healthy volunteer
study, GS-9857 demonstrated a favorable pharmacokinetic profile
(ePoster #P0861). Data from a three-day monotherapy study also
demonstrated that GS-9857 was well-tolerated and achieved median
HCV RNA reductions of more than 3 log10 IU/mL for HCV patients with
genotypes 1, 2, 3 and 4 at the 100 mg dose (ePoster #P0901).
Presented as a late-breaker ePoster (ePoster #LP03), a Phase 2
study of triple-combination therapy with a fixed-dose combination
of SOF/GS-5816 plus GS-9857 among genotype 1 patients demonstrated
sustained virologic response (SVR12) rates following six weeks of
treatment of 93 percent (n=14/15) among treatment-naïve,
non-cirrhotic patients, 87 percent (n=13/15) among treatment-naïve,
cirrhotic patients, and 67 percent (n=20/30) among those who had
failed therapy with two or more direct-acting antiviral agents
(DAAs). The four-week regimen resulted in a sub-optimal SVR12 rate
of 27 percent (n=4/15).
“These data support the ongoing development of GS-9857 and the
potential for an all-oral, triple combination therapy containing
Sovaldi, GS-5816 and GS-9857 to attempt to further reduce treatment
duration for hepatitis C patients,” said Norbert Bischofberger,
PhD, Executive Vice President of Research and Development and Chief
Scientific Officer, Gilead Sciences. “We are encouraged by the
six-week SVR12 rates and other data presented at EASL demonstrating
this regimen’s pan-genotypic potential, and have recently initiated
additional Phase 2 studies to further evaluate the appropriate
treatment duration of this regimen for all patients, regardless of
genotype, including those who have failed prior therapy with
directly acting antivirals and those with cirrhosis.”
SOF/GS-5816 plus GS-9857 was generally well tolerated. There
were no Grade 3 or 4 adverse events nor serious adverse events. The
most frequent adverse events were nausea (25 percent), headache (24
percent) and fatigue (16 percent). Transient, asymptomatic,
elevated lipase (Grade 3 or 4) occurred in four patients (5
percent).
GS-5816 and GS-9857 are investigational products and their
safety and efficacy have not been established. Additional
information about these studies can be found at
www.clinicaltrials.gov.
About Gilead
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. Gilead has
operations in more than 30 countries worldwide, with headquarters
in Foster City, California.
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 risk that Gilead may observe unfavorable results from
additional clinical trials involving GS-9857, including in
combination with Sovaldi and GS-5816. In addition, Gilead may make
a strategic decision to discontinue development of GS-9857,
including in combination with Sovaldi and GS-5816 if, for example,
Gilead believes commercialization will be difficult relative to
other opportunities in its pipeline. As a result, GS-9857 may never
be successfully commercialized. 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 Annual Report
on Form 10-K for the year ended December 31, 2014, 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 Sovaldi
is available at www.gilead.com.
Sovaldi is a registered trademark 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.
Gilead Sciences, Inc.Sung Lee, +1 650-524-7792 (Investors)Nathan
Kaiser, +1 650-522-1853 (Media)Michele Rest, +1 650-577-6935
(Media)
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