Gilead Announces Positive Phase 2 Results for GS-9674 in Primary Sclerosing Cholangitis (PSC) at The Liver Meeting® 2018
November 09 2018 - 8:00AM
Business Wire
– GS-9674 Granted Orphan Drug Designation by
the U.S. Food and Drug Administration –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that
treatment with GS-9674, an investigational, selective, nonsteroidal
farnesoid X receptor (FXR) agonist, led to significant improvements
in liver biochemistry and markers of cholestasis in patients with
primary sclerosing cholangitis (PSC). Data were presented at The
Liver Meeting® 2018 in San Francisco.
PSC is a rare, chronic condition that causes the network of
ducts that drain bile from the liver to become inflamed and scarred
over time. Progressive damage to the bile ducts in patients with
PSC can lead to cirrhosis, liver failure, and cholangiocarcinoma
(cancer of the bile ducts). Fatigue, pruritus and abdominal
discomfort are common symptoms of PSC that can greatly impact
patients’ quality of life. There are no approved treatments for
PSC.
“Gilead is committed to applying our research expertise in liver
disease to address this debilitating condition which may lead to
serious liver-related complications for PSC patients,” said John
McHutchison, AO, MD, Chief Scientific Officer, Head of Research and
Development, Gilead Sciences. “These latest results from our Phase
2 program of GS-9674 are a positive step forward in the search for
effective therapy.”
In the Phase 2, double-blind, placebo-controlled trial, 52
non-cirrhotic patients with PSC were randomized to receive GS-9674
100 mg (n=22), GS-9674 30 mg (n=20), or placebo (n=10) orally once
daily for 12 weeks. After 12 weeks of treatment, patients receiving
GS-9674 100 mg demonstrated significant improvements in liver
biochemistry tests, with a median reduction in serum alkaline
phosphatase (ALP) of 20.5 percent vs. an increase of 3.4 percent
with placebo (p=0.029), median reduction in gamma-glutamyl
transferase (GGT) of 30.3 percent vs. an increase of 1.1 percent
with placebo (p<0.001), median reduction in alanine
aminotransferase (ALT) of 49.4 percent vs. 12.9 percent with
placebo (p=0.009), and a median reduction in aspartate
aminotransferase (AST) of 42.3 percent vs. 10.8 percent with
placebo (p=0.019). In both groups treated with GS-9674, reduced
serum levels of C4, an intermediate in the synthesis of bile acids,
were observed compared with placebo (-23.2 percent in the 100 mg
group, p=0.21; and -30.5 percent in the 30 mg group, p=0.024).
Reductions in serum bile acids were greatest with the 100 mg
dose.
GS-9674 was well tolerated and the incidence of Grade 2 or 3
pruritus was numerically lower with GS-9674 100 mg (13.6 percent)
and 30 mg (20 percent) compared with placebo (40 percent). There
were no elevations in serum lipids. Treatment was discontinued due
to adverse events in three patients treated with GS-9674 100 mg (14
percent), including one discontinuation due to pruritus, and one
patient with placebo (10 percent).
A separate analysis of health-related patient-reported outcome
measures (PROs) among patients enrolled in the Phase 2 trial
demonstrated significant impairment of PRO scores among PSC
patients with pruritus or fatigue. In the evaluation, patients
treated with GS-9674 100 mg experienced significant improvement of
the Primary Biliary Cholangitis – 40 (PBC-40) Emotional score
(p=0.04) compared with patients treated with placebo.
“Patients living with PSC urgently need effective and tolerable
treatment options,” said Michael Trauner, MD, presenting author and
Head of the Division of Gastroenterology and Hepatology at the
Medical University of Vienna, Austria. “These Phase 2 results are
encouraging in terms of beneficial changes in liver biochemistry,
markers of bile acid homeostasis, and patient-reported outcome
measures. We look forward to further determining the safety and
efficacy of this investigational agent.”
GS-9674 is an investigational compound and is not approved by
the U.S. Food & Drug Administration (FDA) or any other
regulatory authority. Its safety and efficacy have not been
determined.
About GS-9674
GS-9674 is an investigational, selective, non-steroidal agonist
of the farnesoid X receptor (FXR), a nuclear hormone receptor that
is highly expressed in the gastrointestinal tract and liver. FXR is
the primary regulator of bile acid synthesis and plays important
roles in glucose and lipid metabolism. GS-9674 is being
investigated for the treatment of PSC, primary biliary cholangitis
(PBC), and advanced fibrosis due to nonalcoholic steatohepatitis
(NASH), a chronic and progressive liver disease characterized by
fat accumulation and inflammation in the liver, which can lead to
scarring or fibrosis. GS-9674 is an investigational agent and its
efficacy and safety have not been determined.
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 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 Gilead’s ability to complete the clinical trial programs
evaluating GS-9674 for the treatment of primary sclerosing
cholangitis in the currently anticipated timelines, or at all. In
addition, there is the possibility of unfavorable results from
additional clinical trials involving GS-9674. Further, it is
possible that Gilead may make a strategic decision to discontinue
development of GS-9674, and as a result, GS-9674 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 Quarterly
Report on Form 10-Q for the quarter ended September 30, 2018, 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.
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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