Article preview reprinted from IN VIVO - October/November, 2009
In early October, EnteroMedics announced the preliminary results of its pivotaltrial on its vagal nerve blocking approach to obesity. The verdict: the study did not meet primary or secondary end points. This was the second neuromodulation company working in obesity (Medtronic was the first) to experience a disappointment in pivotal clinical trials after early results looked so good. Several neurostimulation companies are still targeting obesity. Should their investors be worried? Is this troubling news for the field of neuromodulation at large? Not surprisingly, executives from two neurostimulation companies--IntraPace and Leptos Biomedical--answer the questions simply: no and no. Read more...
Neurostim Companies Defend Their Role in Obesity
Article preview reprinted from IN VIVO - October/November, 2009
The promise of neuromodulation in obesity—and in medicine in general—is ease of use. The devices don't alter a patient's anatomy, are often easily implanted in an outpatient procedure, are non-invasively reprogrammable, and by every measure, safe. But comfort and safety aren't enough. Companies need to show that these devices work, and that's proven to be an elusive goal.
In early October, EnteroMedics Inc. announced the preliminary results of its vagal nerve blocking approach to obesity. Almost 300 patients with a BMI in the range of 35-45 were enrolled in the EMPOWER study, a randomized, double-blind placebo-controlled trial. The verdict: the study did not meet primary or secondary end points. In a conference call announcing the results, president and CEO Mark Knudson, PhD, revealed that for both the treated and placebo groups the percentage of excess weight loss was in "the mid-teens." In other words, the therapy did not outstrip the placebo.
EnteroMedics has since announced that it will reduce its workforce by 40% to conserve cash, while it studies the results and continues with clinical trials of a wholly implantable device in Europe. In its third quarter financial results, the company reported that as of September 30, it had cash of $27 million, enough to carry it into 2010, the company said. Maybe EnteroMedics faced some challenges that were unique to it—for example, a potential lack of compliance from treated patients, who would circumvent the therapy if they didn't wear external controllers. But this was the second neuromodulation company working in obesity to experience a disappointment in pivotal clinical trials after early results looked so good. Medtronic Inc. was the first. In 2005, it reported that its SHAPE trial of a gastric pacing device (gained via the company's acquisition of Transneuronix) failed to meet its efficacy end point.
Perhaps these companies ran up against the challenge that developers of all obesity devices face: the high placebo effect among patients in the control groups of obesity trials.
Several neurostimulation companies are still targeting obesity. Should their investors be worried? Is this troubling news for the field of neuromodulation at large? After all, Northstar Neuroscience Inc., another neurostimulation company, was forced to dissolve recently, despite an extremely successful initial public offering, when it too failed to meet its primary end point in clinical trials. While Northstar's technology was being used to treat stroke, not obesity, it does raise questions about the viability of neurostimulation technology, at least in the minds of investors, because even though Northstar was well-funded, investors chose to dissolve the company rather than pursue alternative clinical applications of the technology. (However, its assets live on under the aegis of St. Jude Medical Inc., which acquired them for $2 million in June 2009).
Not surprisingly, executives from two neurostimulation companies—IntraPace Inc. and Leptos Biomedical—answer the questions simply: no and no. Chuck Brynelsen, president and CEO of IntraPace, tells us that his company has designed an "intelligent" obesity intervention intended to detect when food or drink is consumed and then provide stimulation to cause the patient to feel satisfied well before the stomach is full. The company is focused on achieving significant weight loss without the complications and lifestyle restrictions of the current bariatric surgical procedures, namely gastric bypass and banding. Brynelsen says, "The majority of patients motivated to address their obesity through surgical means are concerned about the risks and complications of bariatric surgery and are therefore waiting for better alternatives to emerge."
The IntraPace technology is differentiated by providing sensor-driven control of the gastric stimulation so that the device only stimulates in response to a sensed eating event. Medtronic and EnteroMedics stimulated intermittently for at least half of the day, which may have led to a reduction in effect over time given the body's possible adaptation to the signal, Brynelsen says. IntraPace believes it will avoid this phenomenon by stimulating only in response to an eating event.
In addition to regulating the delivery of therapy, the sensors in the device collect information about a patient's eating habits and physical activity levels. According to Brynelsen, "Obese patients are often not honest with their physicians about their lifestyle choices. This misinformation makes it difficult for the physician to provide optimal health care management." Information recorded in the device can be downloaded by the clinician during an office visit and used to comprehensively manage the diet and exercise habits of the patient. Behavior modification or lifestyle coaching should be a part of any weight management program, but few companies address this aspect of care, Brynelsen feels. In addition, IntraPace has designed its system to minimize the effect of poor patient compliance. The system is fully implantable and automatic; it does not depend on the patient to recharge or activate it. It collects consumption and exercise data continuously, providing the clinician with objective information on patient behavior.
--Mary Stuart
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Companies mentioned in this article:
Northstar Neuroscience Inc.
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