EnteroMedics ($ETRM) produced mixed results in a pivotal clinical trial testing its VBLOC antiobesity device. Still, the company will proceed with an FDA premarket approval application in the second quarter of 2013.
VBLOC did not meet its defined primary efficacy measures in the ReCharge double-blind sham-controlled trial involving 239 randomized patients in the U.S. and Australia, 233 of which had the actual implanted device. EnteroMedics noted, however, that the trial met its primary safety endpoint and helped more than half of patients lose at least 20% of their excess weight.
"Right now it is our belief that this was a very positive outcome in this trial," CEO Mark Knudson said during a Feb. 7 evening conference call held to discuss the results. "We have a very strong dataset to go to the FDA with. We do not anticipate that we will need to do any more work to be able to show very high benefit, and low risk, and move very confidently forward with our application to the agency."
Knudson also noted during that call that "this was the first device trial with a sham control in this space to achieve a positive outcome."
Specifically, EnteroMedics said the trial achieved a 24.4% statistically significant excess weight loss overall for patients treated with the VBLOC therapy. And at least 52.5% of patients achieved at least 20% excess weight loss. Researchers surgically implanted either a functional device in patients with leads to the vagus nerve, or a device without leads. VBLOC is delivered to patients through the company's Maestro rechargeable system: two electrodes laparoscopically implanted and placed against the trunk of the vagus nerve near the esophagus and stomach. Intermittent high-frequency, low-energy electrical impulses are designed to reduce hunger and create a feeling of fullness. The Maestro system has approval both in the E.U. and Australia.
Obesity treatment remains a multibillion-dollar opportunity in the U.S., and EnteroMedics has fought long and hard to get to this point. In 2009, the company faced a major setback when an anticipated study showed the therapy didn't meet a key goal, though EnteroMedics evaluated the data and determined the device had functioned better than initially thought. After a 40% reduction in its workforce, the money-losing company continued on to raise additional funding and pass the needed regulatory milestones. It remains to be seen how the PMA filing will fare, and EnteroMedics also faces competition from rivals with a similar approach including IntraPace and others.
- read the release