Fractyl touts 1st-in-human data, grabs ex-GI Dynamics medical chief Maggs

Fractyl Laboratories today touted the publication of 1st-in-human data from a trial of its Revita duodenal mucosal resurfacing device and said it picked up former GI Dynamics medical chief Dr. David Maggs, who was fired last June, as its new chief medical officer.

Results from the study were published in Diabetes Care this month, Fractyl said.

The Revita is designed to separate the mucosa and sub-mucosa in the duodenum before ablating the mucosa to help regulate insulin production in Type II diabetics, the Waltham, Mass.-based company said.

“This is the 1st peer-reviewed publication of human clinical data from the proof-of-concept trial. This study is part of a growing body of evidence that suggests Revita DMR may address the underlying metabolic complications of insulin resistance and could represent a new treatment option for patients with type 2 diabetes who are failing oral medications or have evidence of fatty liver disease,” CEO Dr. Harith Rajagopalan said in a press release.

Data from the 30-patient trial indicated “significant improvement” in rates of hyperglycemia in patients with poorly controlled type 2 diabetes who are on one or more oral antidiabetic agent, the company said. Fractyl reported that the treatment was “well tolerated with minimal gastrointestinal symptoms post procedure.”

“The gastrointestinal tract plays a major role in the physiologic regulation of glucose metabolism, so it is plausible that gastrointestinal changes in response to years of exposure to certain foods might contribute to the development of metabolic diseases, especially type 2 diabetes. There is now a solid biological rationale to consider the gastrointestinal tract as an ideal target for anti-diabetes interventions.  In fact, recently recognized new guidelines from international diabetes organizations recommend the use of gastrointestinal surgery as a standard treatment option in certain patients with type 2 diabetes.  However, because surgery is not suitable as mass treatment for the hundreds of millions of patients suffering from diabetes, less invasive approaches that harness the mechanisms of major surgery and reproduce some of its beneficial effects could provide a real opportunity for improvement of diabetes care. The early results with Revita DMR are quite encouraging in this regard,” Dr. Francesco Rubino of London’s King’s College Hospital said in prepared remarks.

The company is currently carrying out a 50-patient, multicenter, international clinical trial in patients with type 2 diabetes, with 40 patients enrolled and treated so far.

Fractyl said it hired on Dr. Maggs, who was axed by GI-Dynamics last June. At the time of the firing, GI Dynamics did not otherwise elaborate on the reason for Maggs’s departure, according to the filing.

Maggs joined GI Dynamics in April 2013 to oversee the clinical development of its EndoBarrier device, a gut liner designed to induce weight loss and help control diabetes in obese patients.

Fractyl said it also opened new 30,000 square-foot headquarters in Lexington, Mass., and hired on Nimesh Shah as its chief business operator.

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