Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from a
Phase 1 clinical trial (GS-US-279-0110) of GS-6615, an investigational,
selective late sodium current inhibitor, showing a shortening of the QTc
interval (the time interval between the start of the Q-wave and end of
the T-wave in the heart’s electrical cycle) in patients with long QT-3
(LQT3) syndrome. LQT3 is a genetic disorder that prolongs the heart’s
QTc interval and can cause life-threatening cardiac arrhythmias
(abnormal heartbeats). Results from this study (Abstract #AB34-05) will
be presented today in San Francisco at the annual meeting of the Heart
Rhythm Society.
The congenital long QT syndromes (LQTS) are a group of inherited
disorders that affect the heart’s electrical system and are
characterized by irregular or rapid heartbeats that can lead to syncope
(fainting), cardiac arrest or sudden cardiac death. Normal QTc intervals
range from 380-460 milliseconds (ms) and LQTS patients typically have a
QTc above 470 ms. LQTS symptoms can occur during strenuous exercise,
emotional stimulation or sleep. The most common types are LQT1, LQT2 and
LQT3. LQT3 is linked to a mutation in the gene encoding the cardiac
sodium channel (SCN5A). Currently, there are no approved medications for
patients with LQT3.
“Over the last several decades, knowledge about LQTS has increased
greatly, including our understanding of genetics associated with
different forms of the disease,” said Arthur J. Moss, MD, Professor of
Cardiology, Department of Medicine, University of Rochester Medical
Center, Rochester, NY. “A key example of this progress is the discovery
that LQT3 is caused by SC5NA mutations in cardiac sodium channels.
Discoveries such as this have helped enable the discovery and
development of much-needed novel therapies for patients with this
life-threatening disease.”
In this study, ten LQT3 patients were evaluated at the Clinical Research
Center at the University of Rochester, where they received single oral
doses of GS-6615 ranging from 10 mg to 60 mg. The study enrolled
patients with a QTc above 480 ms. The QTc pre-dose (Day -1) was compared
to QTc on drug (Day 1) during time-matched 12-hour periods. In the
study, QTc shortening was observed at all dose levels, with maximal QTc
shortening ranging from -44 ms to -80 ms. No safety concerns were
observed during administration with GS-6615.
“QTc shortening observed in this study provides clinical evidence
suggesting that GS-6615 is an inhibitor of the late sodium current with
the potential to play an important role in the treatment of patients
with LQT3,” said Wojciech Zareba, MD, PhD, lead investigator for the
Phase 1 GS-6615 study and Professor of Medicine, Director of Cardiology
Clinical Research and Director of the Heart Research Follow-Up Program
at University of Rochester Medical Center.
Based on these results, Gilead plans to initiate a Phase 2 study of
GS-6615 in LQT3 patients later this year. Additionally, based on
pre-clinical data for GS-6615 and clinical data involving the role of
late sodium current inhibition in other cardiovascular diseases, Gilead
plans to initiate Phase 2 clinical trials in patients with hypertrophic
cardiomyopathy (HCM) and ventricular tachycardia and ventricular
fibrillation (VT/VF).
About GS-6615
GS-6615 is a potent and selective inhibitor of the cardiac late sodium
current, which is associated with various genetic and acquired
cardiovascular disorders, including long QT-3 (LQT3) syndrome,
hypertrophic cardiomyopathy (HCM) and ventricular tachycardia and
ventricular fibrillation (VT/VF).
GS-6615 is an investigational product and its safety and efficacy have
not 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 and South
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 the
possibility of unfavorable results from additional clinical trials
involving GS-6615 in patients with LQT3, HCM and/or VT/VF. In addition,
Gilead may be unable to initiate the Phase 2 trials in the currently
anticipated timelines, may be unable to enroll patients in the studies
and may need to modify or delay these studies. Further, Gilead may make
a strategic decision to discontinue development of GS-6615 if, for
example, Gilead believes commercialization will be difficult relative to
other opportunities in its pipeline. As a result, GS-6615 may never be
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
March 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.
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.
Copyright Business Wire 2014