Full Enrollment Achieved in Endogenex’s ReCET Clinical Study

Endogenex has ended enrollment in a study assessing the safety and effectiveness of the Endogenex System in adult type 2 diabetes (TD2) patients whose blood glucose levels are inadequately controlled with non-insulin, glucose-lowering medications.

The prospective, randomized double-blinded, sham-controlled ReCET trial has signed up 350 patients at 40 clinical sites in the United States and Australia. The study’s primary endpoint measures the change in HbA1c from baseline at six months after the procedure. All participants will be followed for 12 months, with participants in the sham arm offered the opportunity to cross over to receive the Endogenex procedure after the 12-month observation period.

“Completing enrollment of this study reflects the significant unmet need in type 2 diabetes and the growing recognition within the clinical community that treatment approaches reaching beyond pharmacotherapy can offer real value to patients,” said Barham Abu Dayyeh, M.D., Division of Gastroenterology and Hepatology at Cedars Sinai Medical Center and co-principal investigator for the ReCET Study. “The duodenum’s role in metabolic regulation is well established, and the feasibility data from the REGENT-1 program provided a strong scientific basis for this trial. We now have the opportunity to test that hypothesis at scale in a blinded, controlled design, and the results have the potential to open a new chapter in how clinicians approach the care of this disease.”

With enrollment now complete, Endogenex will focus on patient follow-up through the six-month primary endpoint and the full 12-month observation period.

“For many patients with type 2 diabetes, maintaining adequate blood glucose control remains a substantial challenge despite being on multiple medications,” stated Richard Pratley, M.D., senior investigator and Diabetes Program lead | AdventHealth Translational Research Institute and ReCET Study co-principal investigator. “Full enrollment in the ReCET Study is an important step toward determining whether targeted restoration of duodenal function can produce durable, clinically meaningful improvements in glycemic control. I look forward to what the results will show and to what they may mean for how we treat this disease going forward.”

The ReCET Clinical Study’s primary endpoint is the change in HbA1c from baseline at six months. Secondary endpoints include the proportion of participants achieving HbA1c of 7% or below without rescue medication, time in range, total body weight loss, and the incidence of adverse events. The study received IDE approval from the U.S. Food and Drug Administration (FDA) in November 2023.

“Reaching full enrollment in the ReCET Study is a defining moment for Endogenex and for the millions of patients living with type 2 diabetes who deserve better options,” Endogenex CEO Stacey Pugh commented. “Even with the best therapies available today, including GLP-1 receptor agonists and SGLT2 inhibitors, the disease often continues to progress because the gut has gone largely untreated. With 350 patients now enrolled across two countries in this rigorous, controlled study, we are focused entirely on generating the randomized evidence needed to bring this therapy to the patients who need it most.”

The Endogenex procedure is a minimally invasive, outpatient endoscopic procedure that targets the cellular pathology of the duodenum, the small intestine’s first section. Growing evidence suggests that when the duodenum is inflamed and damaged, it disrupts the gut’s ability to sense and communicate with the organs that regulate blood sugar, appetite, digestion, and metabolism. This dysfunction may worsen or even contribute TD2’s cause.

The Endogenex System applies highly controlled, nonthermal pulsed electric fields to the mucosa and submucosa of the duodenal tissue, supporting healthy cell regeneration and aiming to restore proper metabolic signaling from the gut. The system has been evaluated in feasibility studies, including REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands, with results published in Diabetes, Obesity and Metabolism and presented at medical conferences globally.

The Endogenex System has received FDA Breakthrough Device Designation for treating TD2 in adults whose blood glucose levels are inadequately controlled by glucose-lowering medications.

Founded in partnership with Mayo Clinic, Endogenex is pioneering a treatment for type 2 diabetes that targets the likely cause: duodenal damage. The company’s outpatient endoscopic procedure uses non-thermal pulsed electric field energy to treat inflamed and dysfunctional tissue associated with type 2 diabetic duodenopathy. A specialized Endogenex catheter delivers PEF to the mucosa and submucosa of duodenal tissue, initiating the body’s natural process of cell regeneration. The goal is to restore the gut to a healthier state so patients can better manage their symptoms and potentially slow or even stop disease progression.