EnteroMedics Inc (NASDAQ:ETRM) announced the publication of three-year data from the Company’s VBLOC DM2 Study of vBloc® Neurometabolic Therapy in obese patients with Type 2 diabetes. The publication, entitled “Vagal Nerve Block for Improvements in Glycemic Control in Obese Patients with Type 2 Diabetes Mellitus: Three-Year Results of the VBLOC DM2 Study,” was published in the Journal of Diabetes and Obesity.
“In addition to maintaining weight loss over time, successful management of comorbid conditions such as diabetes is critical,” said Charles Billington, M.D., Professor, Department of Medicine, University of Minnesota. “The three-year data from the VBLOC DM2 study continue to demonstrate that vBloc Therapy not only provides durable improvements in weight loss through three years, but also improved glycemic control in obese patients with Type 2 diabetes who do not wish to undergo anatomy-altering weight-loss procedures.”
Results from the study demonstrate that after three years, the average percentage excess weight loss (%EWL) was 21% with reductions in hemoglobin A1c (HbA1c) of 0.6 percentage points from a baseline of 7.8%. This clinically meaningful reduction in HbA1c resulted in 39% of participants either reducing or stopping their diabetes medications. Additionally, 71% of study participants were at or below the American Diabetes Association target for HbA1c for people with diabetes of 7%. Also at three years, mean estimated fasting plasma glucose was significantly decreased by 18 mg/dL from 151 mg/dL at baseline.
“We are encouraged by the strong three year results seen in the VBLOC DM2 study, as the data provides additional evidence of the benefit that vBloc Therapy can offer to patients battling obesity and Type 2 diabetes,” said Dan Gladney, EnteroMedics President, Chief Executive Officer and Chairman of the Board. “Obesity and Type 2 diabetes are two of the most serious societal health concerns throughout the world today, and innovative treatments like vBloc Therapy have the potential to stem the tide against these dangerous and debilitating conditions.”
The DM2 Study is an international, open-label, prospective, multi-center study designed to evaluate the safety and efficacy of vBloc Therapy in 28 diabetic subjects with obesity by measuring average percentage excess weight loss (EWL), HbA1c (blood sugar), fasting plasma glucose (FPG, blood sugar) and blood pressure, following device activation. No deaths, unanticipated adverse device effects, or life-threatening complications occurred through three years.
vBloc Therapy is approved for use in helping with weight loss in people aged 18 years and older who are obese, with a BMI of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with a related health condition such as Type 2 diabetes, high blood pressure, high cholesterol levels or obstructive sleep apnea who have had a poor response to trying to lose weight under supervision in the last 5 years.
Shares of Enteromedics are up nearly 16% to $8.27 in early trading Thursday. ETRM has a 1-year high of $102.20 and a 1-year low of $1.75. The stock’s 50-day moving average is $7.16 and its 200-day moving average is $1.80.
EnteroMedics, Inc. is a clinical development stage medical device company that engages in the design and development of devices that use neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders. Its proprietary neuroblocking technology is designed to intermittently block the vagus nerve using high frequency, low energy, electrical impulses. Its initial product Maestro System, which uses VBLOC therapy to affect metabolic regulatory control, limit the expansion of the stomach, help control hunger sensations between meals, reduce the frequency and intensity of stomach contractions and produce a feeling of early and prolonged fullness.