Three-year results from EnteroMedics’ (ETRM) DM2 ENABLE Study, a small trial of the company’s VBLOC vagal blocking therapy (delivered via the Maestro System), indicate some positive outcomes in diabetic patients, including weight loss and reduced use of medications, though the study’s open-label and uncontrolled design make it difficult to attribute the results exclusively to the Maestro device. No deaths or serious adverse device events were reported in the trial. ETRM jumped 25% in pre-market trading on Thursday morning.
EnteroMedics filed a PMA with the FDA in 2013 based on the 239-patient placebo-controlled ReCharge Trial.
According to the company, at the three year mark 83% of patients who were being treated with one or more diabetic medications at the start of the trial reported no change, a decrease, or discontinuation of their medication; the data were not broken out by segment. ETRM also reported average excess weight loss of 24.3% (p < 0.0001). HbA1c levels dropped from 7.6% to 7.0% (p=0.04), on average, by the 3-year timepoint.
This June, the FDA’s Gastroenterology and Urology Devices Panel (GUDP) advisory panel voted 8 to 1 in favor of Maestro’s safety; voted 4 to 5 against a reasonable assurance of efficacy; and 6 to 2 with 1 abstention on whether the relative benefits outweighed the relative risks. EnteroMedics expects a final approval decision by the end of the year.
EnteroMedics will present the ENABLE data on Thursday at the 19th Meeting of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO).
