May 09, 2014
Gilead Announces Phase 1 Data for Investigational Therapy, GS-6615, in Patients with Long QT-3 Syndrome
Data Presented at Heart Rhythm 2014 Support Plans for Phase 2 Clinical Trial in LQT3 Patients
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
In this study, ten LQT3 patients were evaluated at the
“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
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).
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,
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
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