HumaGraft is being developed to help provide reliable and robust vascular access for haemodialysis patients with end stage renal disease and to reduce or avoid certain serious complications that arise with the current standards of care associated with the current forms of vascular access for haemodialysis.
Fast Track designation means that the FDA will take actions to facilitate the development and review of the product for the designated medical use. Fast Track Development Programmes are eligible for more frequent meetings and written correspondence with FDA, for priority review if relevant criteria are met at the time when an application for approval is submitted, and potentially for “rolling review,” under which parts of the application may be accepted earlier than usual.
Carrie Cox, chairman and chief executive officer, comments, “The fast track designation for HumaGraft recognises the significant unmet need that exists and provides options for vascular access in haemodialysis patients. We will continue to work closely with the FDA to ensure the most efficient review process as we advance the development of HumaGraft for patients needing haemodialysis access.”
Potential Better Alternative to Current Synthetic Grafts
Current standard of care for patients with end stage renal disease requiring haemodialysis includes surgery to create a fistula in the patient or the use of synthetic polytetrafluoroethylene (PTFE) grafts. Up to 70% of high risk patients (eg., certain combinations of obese, diabetic patients, etc.) may not be candidates for a fistula. Likewise, PFTE grafts are subject to a range of complications, including clotting, high rates of stenosis, and high intervention rates to maintain blood flow. Preliminary clinical findings suggested that HumaGraft may provide an alternative to these current surgical options to maintain long-term vascular patency in haemodialysis patients. HumaGraft is designed to be available off-the-shelf in the operating room, with the potential to help reduce or avoid surgical interventions and hospitalisations for patients with end stage renal disease.
Humacyte recently announced that it has completed recruitment for two phase I/II studies (one in Europe and one in the United States) for HumaGraft as a vascular access for haemodialysis. A separate investigational trial involving 20 patients with peripheral arterial disease who received a HumaGraft implant as a femoropopliteal bypass is fully enrolled and ongoing in Poland.