New GI Dynamics (ASX:GID) CEO Scott Schorer is looking to reboot the company’s flagship EndoBarrier weight loss device, after a higher-than-expected rate of liver abscesses forced the halt of a clinical trial last year.
The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract. Schorer, a medical device veteran with stints as an executive or advisor at a raft of companies under his belt, told MassDevice.com that the EndoBarrier is a unique product.
“There’s nothing that does what this device does,” Schorer told us. “When you look at combination therapy, there are no drug-drug interaction issues [with EndoBarrier], because we are not a drug. The clinical benefit of this device is why I’m here. This product has to be saved.”
The company is looking into possible causes for the hepatic abscess cases, and reviewing different clinical approaches used with the EndoBarrier treatment, to standardize best practices.
“We are doing more basic science than was done here before,” Schorer said. “We’re looking at what builds up on the EndoBarriers in the field and bringing those to labs and doing a DNA analysis to see what type of bugs are on there.
“A lot of it is how the big sites around the world have evolved their practice and patient selection and education, maybe little tweaks they’re doing in the procedure room during the implants,” he said, noting that some sites take differing approaches to proton-pump inhibitors and antibiotics. GI Dynamics is running a Six Sigma audit of the clinical sites to help establish the root cause of the abscess issue and establish best practices across its clinical sites Schorer told us.
Schorer wasn’t long in the corner office in Lexington, Mass., before instituting a 30% cut to the workforce, in an effort to cut the company’s cash burn as it pursues FDA approval for the EndoBarrier. The company is also looking at the data from the halted Endo trial, and has several other studies either planned or already under way. The hepatic abscess issue is now well-known to physicians using EndoBarrier in Europe, he said.
“We’ve shipped more than 3,600 EndoBarriers worldwide and have 39 cases of hepatic access. None have resulted in death; all have been treated. We think that we can reduce the rates of hepatic abscess. That 39-over-3,600 is a less than 1.1% rate. Many clinicians say they are totally comfortable with that rate – or higher, 2% or 3% in their practice – because of the benefits,” he explained. “They are now aware of it, especially in Europe. They’ve been aware of hepatic abscess, they are just really focused on early detection.”
Data presented earlier this month at the Endocrine Society’s annual meeting showed that patients treated with the EndoBarrier along with the anti-diabetes drug liraglutide showed the largest benefit in both reduced hbA1c levels and weight loss. When combined with EndoBarrier treatment, patients on liraglutide required fewer medicines than subjects in the liraglutide arm.
“The really remarkable stuff [from the trial] doesn’t come across immediately. One, 25% of the combination therapy patients reduced their diabetes medication, including insulin. A full quarter went lower on medication and our baseline in the liraglutide combo therapy was 33% lower,” he said. “What is really interesting here is the EndoBarrier alone produced an extraordinary delta in weight loss. At least 8 kilos more weight loss. Then that was the same weight loss in the combination therapy.
“I think that once people get more comfortable with the safety profile, we’re in an entirely different place.”
