Eleclazine: The Liberty HCM Trial
It appears to be the end of the road for the Gilead drug eleclazine, a late sodium channel inhibitor previously known as GS-6615. Eleclazine, with properties similar to the anti-angina drug ranolazine (which was approved by the FDA in 2006), was the subject of a recently terminated HCM clinical trial known as Liberty-HCM. The HCM eleclazine study focused on whether the drug would improve symptoms and exercise capacity in patients with HCM by increasing their peak oxygen uptake, resulting in improved VO2 max readings on exercise testing. The HCM study began enrolling patients in February 2015. Data collection had been scheduled to continue through June 2017.
In addition to Gilead’s research related to eleclazine in HCM, there were concurrent studies looking at the safety and efficacy of the drug in 2 other patient populations: patients with Long-QT syndrome type 3, and patients with ventricular tachycardia (VT) and ventricular fibrillation (VF) who also have implantable cardioverter-defibrillators.
Gilead’s 3rd Quarter Statements About Eleclazine
During a November 1, 2016 telephone report of Gilead’s 3rd quarter corporate earnings, Norman Bischofberger, the company’s Chief Scientific Officer, stated that eleclazine failed to show a reduction of ICD shocks and pacing events in patients with VT and VF when compared to a placebo. Hence, the company announced that it would cease development of eleclazine for VT/VF. However, during that call, Bischofberger also stated that the trials of the drug for long QT-3 syndrome and for hypertrophic cardiomyopathy would continue. However, it seems that Gilead later had a change of heart and reversed its position. Patients enrolled in the Liberty-HCM study began receiving phone calls informing them of the discontinuation of the study in mid-December.
What the Patients in the Study Were Told
According to several people with whom I spoke in connection with this article, enrolled patients were informed that the trial was terminating, effective immediately. They were instructed to schedule an appointment with their study coordinator as soon as possible, after which they should discontinue the drug. Finally, they were told to return all unused drugs and pill containers to the study site and to expect one final visit to the study site in 2017.
Gilead Confirms Discontinuation of the Study
After hearing of the discontinuation of the study from enrolled patients, I decided to contact Gilead and inquire whether there was a future for eleclazine. Nathan Kaiser, Associate Director of Public Affairs at Gilead, provided the following statement:
“After a thorough analysis of clinical information that has occurred since our announcement last month, Gilead has determined that the totality of the data do not support continuation of the eleclazine development program. Therefore, all ongoing trials including hypertrophic cardiomyopathy and long QT-3 syndrome will be stopped. Unfortunately, we are not able to comment further at this time. However, we are committed to sharing the data with the HCM community at a future scientific meeting and we would be happy to provide further information at that time.”
What Does This Mean for HCM Patients?
So, at least for the meantime, it appears that eleclazine has been abandoned as a potential treatment for HCM. This is unfortunate for all HCM patients; especially for those who thought that they had seen a benefit from eleclazine, though even these patients can’t be certain that the drug caused the improvement since they may not have actually been taking eleclazine. Liberty-HCM was structured as a double-blind study meaning that patients were randomly assigned to take either the drug or a placebo. Neither the patient nor those overseeing the study know which patients fell into each group.
The end of the eleclazine trial still leaves two other drugs in the pipeline for HCM: Myokardia’s MYK-461 for obstructive HCM, now in Stage 2 trials, and Heart Metabolic Limited’s Perhexiline, moving into Stage 3 trials for patients with moderate to severe heart failure.
Hopefully, other drug companies will see a benefit in developing drugs for HCM so that we may have more options in the future. Stay tuned to HCMBeat for future updates about new drugs and treatments for HCM.
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