Nectero Medical today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Nectero Endovascular Aneurysm Stabilisation Treatment (Nectero EAST) system to treat patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5–5cm. Nectero Medical is initiating a randomised, controlled Phase II/III clinical trial (stAAAble) to evaluate the product’s safety and effectiveness with first subject enrolment targeted in Q4 2023.
Breakthrough Therapy designation is an FDA programme intended to facilitate design and conduct of an efficient product development programme. It is a challenging status to obtain. Designation requires that the novel drug treats a serious condition, and preliminary clinical evidence indicates that the drug may provide a substantial improvement over available therapy on a clinically significant endpoint(s). Nectero Medical’s Breakthrough Therapy designation is supported by results from the first-in-human (FIH) study of the Nectero EAST system. Early clinical results of the FIH study were recently published in the Journal of Vascular Surgery and showed that a single, localised pentagalloyl glucose (PGG) administration to patients with small- to medium-sized infrarenal AAAs was safe and demonstrated the potential to slow the growth of AAAs. Additional follow-up data will be presented at the VEITHsymposium 2023 (14–18 November, New York, USA).
In addition to the benefits of Fast Track (received in August 2023), which allows for more frequent FDA interactions and eligibility for priority and rolling review, Breakthrough Designation adds FDA’s organisational commitment to involve senior managers. Nectero Medical will meet with the Agency near term to review the development programme and establish a plan for ongoing communications.
“This designation reinforces Nectero Medical’s belief that the Nectero EAST system has the potential to have a significant impact for patients with AAA disease,” said Jack Springer, president and chief executive officer of Nectero Medical. “We look forward to working closely with the FDA to advance this product to patients as quickly and efficiently as possible.”