Background: End-stage renal disease (ESRD) is a major cause of morbidity and mortality in the United States. The prevalent (and growing) population with ESRD has exceeded 300,000 subjects with approximately 180,000 subjects on hemodialysis. The most common form of dialysis vascular access is an arteriovenous graft, which is utilized in approximately 60-70% of hemodialysis patients.

Problem: While these grafts provide ready and adequate blood flow rates for dialysis treatment, they are prone to complications; the foremost of which is graft thrombosis and stenosis. This occurs with an event rate of nearly 50% per year, leading to a huge rate and expense of interventions to maintain the access including interventional thrombolysis and angioplasty and surgical thrombectomy and graft revision. This leads to a graft half-life of only two years. These complications lead to dialysis access costs contributing to 15-25% of the entire dialysis budget. There are no present treatments to slow or stop the process of graft stenosis that is chiefly caused by post-anastomotic intimal hypertrophy of the access vein.

Lumen Therapeutics' Solution: Lumen plans a second dosage form and administration strategy (product candidate LT-1945) to optimize oligo-L-arginine for patients having a vascular access arteriovenous graft (AVG). LT-1945 will be used during the procedure and possibly at subsequent procedures where the shunt is accessed during dialysis. Success in CABG and PABG indications with LT-1951 will lend significant weight to the viability of LT-1945 using the same type of pharmacological intervention with a different dosage form and a different delivery methodology.