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Revita-1 and -2 outcomes

Fractyl reveals positive data from Revita-1 and Revita-2 studies

Revita-2 results help to establish the safety and effectiveness of Revita in improving glucose control, reducing liver fat content, enhancing insulin sensitivity, and reducing weight in patients with T2DM

Fractyl Laboratories has revealed positive results from the long-term follow-up from the Revita-1 Revita-2 clinical studies. The outcomes from Revita-1 clinical study presented at the Diabetes Technology Meeting in Bethesda, MD, showed that patients experienced a 1% reduction in HbA1c (from a baseline HbA1c of 8.5% to 7.5%; n=34; p< 0.01) through 24 months of follow-up from a single outpatient Revita DMR procedure.

Durable improvements in liver biomarkers were also observed over the same length of time, indicating the potential for Fractyl’s Revita DMR (duodenal mucosal resurfacing) to offer durable improvements in both type 2 diabetes and nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) for a full two years. In addition, the data shows an 80% response rate with a large magnitude reduction in responders. Patient satisfaction scores were significantly improved at 12 months and no late adverse events attributable to Revita were observed.

“Diabetes is a chronic progressive disease characterized by ongoing deterioration of glycaemic control, even in the presence of an increasing number of anti-diabetic medications. What is sorely needed is an effective means of changing the trajectory of disease for patients,” said Dr Alan Cherrington, Professor of Molecular Physiology and Biophysics, Professor of Medicine & Jacquelyn A Turner and Dr Dorothy J Turner Chair in Diabetes Research, Vanderbilt University. “This work shows that ablation of the duodenal mucosa via Revita may provide a safe and effective means of achieving that reversal, targeting the gut to address a core pathophysiological mechanism of disease.”

Revita-2

Fractyl also announced positive results from the Revita-2 trial evaluating Revita DMR for the treatment of T2DM patients with and without NAFLD. The results from Revita-2, Fractyl’s first sham-controlled, multi-centre clinical trial of Revita DMR, were presented at the annual meeting of the American Association for the Study of Liver Disease in Boston.

The Revita 2 study was a double-blinded study of the Revita DMR procedural therapy, in which patients enrolled in the study and the physicians caring for the patient after the procedure, were blinded to the treatment arm for 24 weeks through the primary endpoint. The trial tested a 10cm circumferential ablation length (10cm dose) versus a sham procedure (in which the Revita catheter was inserted into the duodenum for a similar duration, but not activated). In both treatment arms, all patients received a two-week post-procedure graduating diet from liquids to semi-solids and solids.

For the twin primary endpoints of reduction in HbA1c and liver MRI-PDFF, Revita DMR demonstrated a statistically significant improvement over sham, with a 0.8% reduction in HbA1c at 24 weeks and a 32% relative reduction in MRI-PDFF at 12 weeks (per protocol study results; p<0.05 for each endpoint). Reductions in HbA1c were caused by improvements in fasting glucose, and patients with higher fasting plasma glucose at baseline had a 1.2% reduction in HbA1c at 24 weeks (p<0.01).

“This data shows that duodenal mucosal resurfacing (DMR) can improve liver metabolic health, leading to improvements in both blood sugar and liver disease simultaneously,” said Dr Arun Sanyal, Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University. “This data supports Revita DMR as a non-pharmacological intervention for patients who are managing type 2 diabetes and NAFLD/NASH and shows that Revita DMR can provide significant improvements in blood glucose levels and liver insulin resistance, even for those patients with NAFLD.”

Sustained improvements in both liver insulin sensitivity and pancreatic beta-cell function were seen after the procedure. The data also showed that Revita DMR, is safe relative to a sham upper endoscopy procedure.

“Revita is a fundamentally different approach to treating type 2 diabetes and NAFLD/NASH that we believe provides significant and sustained metabolic benefits from a single, outpatient therapy,” said Dr Harith Rajagopalan, co-founder and CEO of Fractyl. “Revita’s effects appear to be durable through at least 24 months in a majority of patients, demonstrating its potential to ameliorate these two major pandemics with a straightforward, outpatient procedural therapy performed under an hour in a manner that is complementary to existing therapies. Revita-2 results help to establish the safety and effectiveness of Revita in improving glucose control, reducing liver fat content, enhancing insulin sensitivity, and reducing weight in patients with type 2 diabetes. These data will be critical to helping us continue development of Revita in type 2 diabetes with NAFLD.”

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