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Revita DMR outcomes

Revita DMR improves hyperglycaemia in T2DM

The Revita DMR device allows physicians to easily separate the mucosal layer of the duodenum from the sub-muscosa
DMR significantly improved glycaemic control in patients with type 2 diabetes, with a predominant effect of lowering fasting hyperglycaemia, suggestive of a potential insulin-sensitising mechanism

Fractyl Laboratories has announced the publication of data in the Diabetes Care journal from its first-in-human study of Revita duodenal mucosal resurfacing (Revita DMR) technology. The company claims procedure has the potential to delay the need for insulin therapy and free patients from the burdens associated with managing type 2 diabetes, particularly when oral medications have failed. 

The paper, ‘Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis from the First-in-Human Proof-of-Concept Study’, is the first comprehensive analysis and publication of data from 39 patients in the first-in-human Revita DMR trial.

“This is the first peer-reviewed publication of human clinical data from the proof-of-concept trial,” said Dr Harith Rajagopalan, co-founder and CEO of Fractyl. “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.”

The Revita DMR device allows physicians to easily separate the mucosal layer of the duodenum from the sub-muscosa

Revita DMR is a trans-oral procedure targeting the duodenum, a portion of the intestine that plays an important role in regulating insulin sensitivity and metabolic homeostasis. Using proprietary balloon catheters, Revita DMR uses a combination of circumferential mucosal lift and hydrothermal ablation to rejuvenate the surface of the duodenum and potentially alter gut signalling in patients with metabolic diseases driven by insulin resistance. It is designed to be a short (<60min) procedure with the potential to restore metabolic health, while avoiding many of the challenges patients and physicians face managing complicated medical regimens. 

After the mucosal layer is separated, the ablation balloon catheter is delivered into the duodenum

In the study, 39 patients with type 2 diabetes (screening HbA1c 9.5% [80mmol/mol]; BMI31) were treated and included in the interim efficacy analysis: 28 had a long duodenal segment ablated (LS; ∼9.3 cm treated) and 11 had a short segment ablated (SS; ∼3.4 cm treated). Overall, DMR was well tolerated with minimal gastrointestinal symptoms postprocedure. Three patients experienced duodenal stenosis treated successfully by balloon dilation.

HbA1c was reduced by 1.2% at six months in the full cohort (p<0.001). More potent glycaemic effects were observed among the LS cohort, who experienced a 2.5% reduction in mean HbA1c at three months post-procedure vs. 1.2% in the SS group (p<0.05) and a 1.4% reduction at 6 months vs. 0.7% in the SS group (p=0.3). This occurred despite net medication reductions in the LS cohort between 0 and six months. Among LS patients with a screening HbA1c of 7.5–10% (58–86 mmol/mol) and on stable antidiabetic medications post-procedure, HbA1c was reduced by 1.8% at six months (p<0.01).

Overall, Revita DMR was well tolerated with minimal gastrointestinal symptoms post procedure. In the study, DMR significantly improved glycaemic control in patients with type 2 diabetes, with a predominant effect of lowering fasting hyperglycaemia, suggestive of a potential insulin-sensitising mechanism.

“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,” said Dr Francesco Rubino, Chair of Bariatric Surgery at King’s College London and Consultant Surgeon at King’s College Hospital in London, UK. “There is now a solid biological rationale to consider the gastrointestinal tract as an ideal target for anti-diabetes interventions. In fact, recently recognised 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.”

The company has initiated a 50-patient, multi-centre, international clinical trial in patients with type 2 diabetes, in which 40 patients have already been treated across sites in the UK, Chile, Italy, Netherlands and Belgium.

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