Biopharmas are looking to incorporate wearables when it comes to patient monitoring within clinical trials. Questions about how this data will or should be used still remain for regulators.
But Gilead Sciences has started a Phase II/III trial of its novel hypertrophic cardiomyopathy candidate eleclazine that incorporates the iRhythm ZIO Patch to measure an exploratory endpoint (a patch worn to monitory changes in arrhythmia).
The patch monitors things like premature ventricular complexes, non-sustained ventricular tachycardia and paroxysmal atrial fibrillation – the goal is to catch hypertrophic cardiomyopathy (HCM) quick. This is the most common cardiac disorder, but it is commonly not diagnosed, and there is not approved treatment currently.
The current Gilead study is called LIBERTY-HCM. A 180-patient study started in February and is designed to test iRhythm’s ZIO Service.
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. This is the first study of its kind for looking how to optimize treatment for 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.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Photos: Flickr user aussiegall, iRhythm
