(By Balaseshan) Abbott Laboratories (NYSE: ABT) said it has began ABSORB III clinical trial in patients in the United States for the treatment of coronary artery disease, which is a narrowing of one or more arteries that supply blood to the heart.
This randomized, controlled trial is designed to enroll about 2,250 patients, the majority in the U.S., and compare the performance of Abbott's drug eluting Absorb Bioresorbable Vascular Scaffold (BVS) device to its XIENCE family of drug eluting stents, the company noted.
The start of this trial in the U.S. follows the recent international commercial launch of Absorb in Europe and parts of Latin America and Asia, including the recent regulatory approval and launch in India, a country with a significant and growing prevalence of heart disease. Data from the ABSORB III trial will support U.S. regulatory filings for Absorb.
The ABSORB III clinical trial is designed to evaluate potential benefits of Absorb in patients with coronary artery disease. Unlike a permanent metallic stent, preliminary evidence of natural vessel function suggests that treatment with an Absorb BVS could provide important clinical benefits.
The primary endpoint of ABSORB III is target lesion failure, a combined measure of safety and efficacy, at one year. In addition, a subset of patients within the trial will be evaluated for novel endpoints such as vasomotion, a measure of how much natural motion returns to the vessel as Absorb dissolves into the arterial tissue.
Absorb, a drug eluting, fully bioresorbable vascular scaffold, is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.
Absorb works by opening a clogged vessel and restoring blood flow to the heart similar to a drug eluting metallic stent, the current standard of care. Absorb then dissolves into the blood vessel, leaving behind a treated vessel that may resume more natural function and movement because it is free of a permanent metallic implant.
Abbott's BVS delivers everolimus, an anti-proliferative drug used in Abbott's XIENCE coronary stent systems. Everolimus was developed by Novartis Pharma AG (NYSE: NVS) and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent or scaffold implantation.
ABT is trading down 0.15% at $33.29 on Tuesday. The stock has been trading between $31.64 and $72.47 for the past 52 weeks.