Nectero Therapeutics announced this week new data from a first-in-human (FIH) multicentre study evaluating the treatment of small- to medium-sized abdominal aortic aneurysms (AAAs) with pentagalloylglucose (PGG) using its investigational Nectero endovascular aneurysm stabilisation treatment (EAST) system. The study met safety endpoints and AAA growth rates were significantly lower than expected through two years post-treatment.
At the Society for Vascular Surgery’s (SVS) Vascular Annual Meeting (VAM26; 10–13 June, Boston, USA), the impact of PGG treatment on proximal neck dynamics was presented by Matthew Eagleton (Massachusetts General Hospital, Boston, USA).
The FIH study enrolled 46 patients with AAAs of a median maximum diameter of 4.3cm. Patients were treated with a PGG drug solution delivered directly to the aneurysm wall through a dual-balloon catheter. Patient follow-up was completed with 44 patients through year one and 41 patients through year two.
While the endpoints of the FIH study focused on patient safety, procedural success, and AAA growth dynamics, investigators also examined the morphology of the adjacent proximal neck tissue, including changes in diameter, length, angulation, and thrombus burden. A Nectero press release notes that the proximal neck is the most critical anatomical factor dictating whether a patient will qualify for endovascular aneurysm repair (EVAR) versus open surgical repair.
Eagleton concluded: “The data show stable proximal neck diameters in the first 15mm below the lowest main renal artery with angulation remaining stable and a slight reduction in proximal neck thrombus through two years. Maintaining proximal neck anatomy and future seal zone eligibility would allow these patients to retain access to less invasive endovascular repair should they eventually reach treatment thresholds. Patients will continue to be followed through three years.”
In addition to ongoing follow-up in the FIH study, the company shares that it is currently enrolling in a pivotal 400-patient randomised controlled clinical trial evaluating the effect of PGG treatment versus standard-of-care surveillance of small- to medium-sized AAA.
