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| ZIO XT Patch--Courtesy of iRhythm |
Biopharmas are interested in incorporating wearables that offer continuous patient monitoring into clinical trials of their drug candidates. But it's still early in terms of understanding how these sorts of data can be used--and what regulators will make of them.
One biotech, Gilead Sciences ($GILD) has started a major Phase II/III trial of its novel hypertrophic cardiomyopathy candidate eleclazine that incorporates the iRhythm Zio Patch to measure an exploratory endpoint.
The cardiac monitoring patch, which can be worn continuously for up to two weeks with subsequent data analysis, is being used to measure an exploratory trial endpoint--the change in arrhythmia burden including premature ventricular complexes, nonsustained ventricular tachycardia and paroxysmal atrial fibrillation.
Hypertrophic cardiomyopathy is the most common inherited cardiac disorder. It's also the most common cause of sudden cardiac death in young adults and a major cause of morbidity due to chronic heart failure symptoms. It occurs in about one in 500 adults, but only a fraction of them are diagnosed. There is no approved treatment for HCM.
As the disease progresses, a number of cardiac problems can occur such as diastolic heart failure, microvascular dysfunction, atrial fibrillation and sudden cardiac death.
The ongoing Gilead eleclazine study is called LIBERTY-HCM; as part of the study patients will receive "periodic arrhythmic burden assessments using iRhythm's ZIO Service to determine if the investigational treatment improves symptoms such as AFib in patients with symptomatic HCM," according to iRhythm.
The 180-patient trial started in February 2015; it's slated to have final primary endpoint data in January 2017 with study completion in June 2019. The primary outcome is change in peak oxygen uptake (VO2) from baseline screening to 24 weeks. The LIBERTY-HCM trial is the first and largest randomized, double-blind, placebo-controlled clinical trial to test eleclazine, a late sodium current (INaL) inhibitor, in patients with symptomatic HCM.
The iRhythm patch is also in a massive up to 6,100 patient trial by the Scripps Translational Science Institute (STSI) to identify asymptomatic atrial fibrillation (AFib) patients that launched late last year.
- here is the iRhythm trial description
- here is a recent paper in Circulation: Heart Failure on the trial
- and here is the ClinicalTrials.gov trial record
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