Gilead Announces Phase 1 Data For GS-6615 In Patients With Long QT-3 Syndrome

(RTTNews) - Gilead Sciences, Inc. (GILD) announced results from a Phase 1 clinical trial of GS-6615, an investigational, selective late sodium current inhibitor, showing a shortening of the QTc interval in patients with long QT-3 or LQT3 syndrome.

The company said LQT3 is a genetic disorder that prolongs the heart's QTc interval and can cause life-threatening cardiac arrhythmias or abnormal heartbeats.

The congenital long QT syndromes or 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 fainting, cardiac arrest or sudden cardiac death, the company noted.

Gilead said normal QTc intervals range from 380-460 milliseconds 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. Currently, there are no approved medications for patients with LQT3.

In this study, ten LQT3 patients 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 was compared to QTc on drug 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, Gilead said.

Based on these results, Gilead plans to initiate a Phase 2 study of GS-6615 in LQT3 patients later this year.