A clearly elated Stu Randle told MassDevice.com today that the FDA’s decision to allow GI Dynamics (ASX:GID) to skip directly to a pivotal trial for its EndoBarrier gastrointestinal liner represented a "huge milestone" for the medical device company.
GID announced earlier that the company won conditional FDA approval for a U.S. pivotal clinical trial of the EndoBarrier in treatment of diabetes and obesity, skipping the pilot trial process, a move the CEO of the Lexington, Mass.-based company said could help speed up a U.S. launch.
"This is something we were hopeful for and we’re thrilled with the outcome," Randle told us in a telephone interview.
The FDA signed off on the overall pivotal trial design using study data from outside the U.S., allowing GI Dynamics to move forward with Institutional Review Board approval while hashing out the details of the new study. The pivotal trial will span 25 U.S. sites, enrolling about 500 patients with uncontrolled diabetes and assessing improvements in diabetes over a period of 12 months.
We spoke to Randle to figure out how this could impact the company in the near future:
MassDevice: The FDA allowed you use data from outside the U.S. Is that a unique scenario?
Stuart Randle: Unique is not a bad word for it. It doesn’t happen all the time. What they evaluated was the data from outside the U.S. from all of our studies in composite, as they evaluated whether there was sufficient safety and efficacy data to allow us to go directly into the pivotal trial. They obviously concluded that the answer to that is yes.
I think it confirms that we ran very well-designed studies with good control and good data outside of the U.S. It make FDA more comfortable that this is a solid data set and a solid plan and foundation.
MassDevice: In terms of capital, you told us that the initial public offering GID raised last year provided enough capital to push through to U.S. clinical studies. Is that still the case, or will you need to raise some more funds?
SR: We haven’t commented on that, but the capital raised in the IPO assumed we would run a pilot study, not a pivotal study. We now have approval for this pivotal study, so we’re continuing to evaluate and look at current capital in the company. The pivotal study is much larger than the pilot study, so we’re evaluating what we’re going to do relative to the capital.
MassDevice: Tell us how this accelerates any timelines for a U.S. commercial launch of the EndoBarrier?
SR: We expect that it will accelerate approval from what we had previously laid out. How much of an impact is yet to be determined, based on negotiation of contracts and IRB approval once we have full FDA approval. The enrollment period is really the key variable. In addition to that, we hope to work closely with the FDA once the trial is concluded, to move as rapidly as we can from data collection through to whatever panel meeting may be required.
I think given that we’re going right into a pivotal trial, it will clearly shave time off a pathway that included a pilot. How much [time] is unclear at this moment.
MassDevice: How confident do you feel that the bariatrics market is still as robust as you’ve predicted?
SR: We feel very confident, because we’re going after a diabetes indication in the obese population and that’s a pretty large market with patients in desperate need for new options and less invasive options. We feel great about the market opportunity and the uniqueness of the patient population and uniqueness of our technology and results. So we’re really optimistic about that.
MassDevice: How does the reimbursement picture look for the EndoBarrier?
SR: We’ve started down the path of understanding that process and putting elements into the pivotal trial that will be important for reimbursement. That’s where we’re at today and that’s where we would like to be.
This is a huge milestone for the company. Everyone inside the company is thrilled. It’s been a lot of hard work by a lot of people here. We’ve had good conversations in collaboration with the FDA and we’re excited to get started here. It’s a great therapy for these patients and we’re excited to provide this treatment to patients inside the U.S. now