Nectero’s EAST System Will Be Studied in Phase II/III STAAABLE Trial

July 24, 2023—Nectero Medical, a clinical-stage biotechnology company developing therapies to treat aneurysmal disease, announced that the FDA granted investigational new drug (IND) clearance for the company to initiate a prospective, multicenter, randomized clinical trial to evaluate the safety and efficacy of the Nectero endovascular aneurysm stabilization treatment (EAST).

According to the company, STAAABLE—small- to midsized abdominal aortic aneurysms (AAA) stabilization: evaluation of efficacy clinical trial—will include patients with infrarenal abdominal aortic aneurysms (AAAs) with maximum diameters of 3.5 to 5.0 cm.

Nectero’s EAST is a single-use, endovascular system for the treatment of infrarenal AAA. The system is comprised of a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG).

The system delivers PGG locally into the aneurysmal wall where it binds to elastin and collagen to strengthen the aortic vessel wall and potentially reduce the risk of further degradation. The procedure does not require any specialized tools or training, takes less than an hour to complete, leaves no permanent implant behind and does not preclude any future interventions, stated Nectero.

Dan Clair, MD, Professor and Chair, Department of Vascular Surgery, Vanderbilt University Medical Center, serves as coprincipal investigator for the STAAABLE study.

“I am very encouraged by the initial data of the Nectero EAST system to potentially slow the growth of AAAs and thereby minimize the likelihood of rupture and/or need for major intervention,” commented Dr. Clair in Nectero’s press release. “If proven safe and efficacious at stabilizing AAA growth, the Nectero EAST system has the potential to transform the lives of thousands of patients with aneurysmal disease.”

Dr. Clair added, “We are honored to be one of the centers to participate in this groundbreaking study that is likely to have a pronounced impact on the future management of AAA patients.”

Nectero Medical stated that the IND submission was supported by a prospective, first-in-human study of 21 patients treated outside the United States.

Early phase I clinical results were recently published online by Stephen W.K. Cheng, MS, et al in the Journal of Vascular Surgery. The study showed that a single, localized PGG administration to patients with small- to medium-sized infrarenal AAAs was safe and demonstrated the potential to slow the growth of AAAs.