Fractyl Health, Inc. (Nasdaq: GUTS) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its Revita System for maintaining weight loss in individuals who have discontinued GLP-1 (glucagon-like peptide-1) drugs. This designation aims to expedite the review process for promising technologies addressing unmet medical needs. The anticipated data readouts from the REMAIN-1 pivotal study are expected to begin in Q4 2024.
Revita System: Targeting the Root Cause of Metabolic Disease
Revita is an outpatient endoscopic procedure designed to resurface the mucosal lining of the duodenum. The duodenum, located just after the stomach, plays a crucial role in breaking down food into absorbable nutrients. Research suggests that the duodenal lining can thicken due to high-fat and high-sugar diets, impairing the body's ability to maintain healthy metabolism and blood glucose levels. Revita aims to reverse this pathology, potentially offering a disease-modifying therapy for obesity and type 2 diabetes (T2D).
The Need for Sustainable Weight Management
Obesity is a prevalent and complex disease associated with cardiometabolic complications, including T2D. While GLP-1 agonists have transformed diabetes and obesity treatment, with over 40% of U.S. diabetes patients and 12 million U.S. adults using them for weight loss, discontinuation rates remain high due to side effects, cost, and access issues. Studies show that up to 66% of weight lost is regained within a year of stopping GLP-1 drugs, highlighting the need for sustainable solutions.
Clinical Trials and Future Data
The REMAIN-1 trial is a randomized, double-blind study comparing Revita to a sham procedure in individuals who have lost at least 15% of their total body weight on tirzepatide. This trial is designed to support regulatory filing for Revita. An open-label study is also underway to provide ongoing data updates. Previous studies in T2D patients in the U.S. and EU have suggested Revita's potential for durable weight maintenance after a single procedure. In Germany, Revita is approved for T2D treatment and has reimbursement support from CMS.
Expert Commentary
"Patients who discontinue GLP-1 drugs need a reliable off-ramp that will allow them to maintain weight loss without having to continue taking these medicines," said Harith Rajagopalan, M.D., Ph.D., Co-founder and Chief Executive Officer of Fractyl. "Breakthrough Device Designation from the FDA validates Revita’s potential for these patients. We believe durable weight maintenance is the single largest unmet need in obesity today, and we believe Revita is one of the only investigational products that is being evaluated in a pivotal study to test its potential to provide sustained weight maintenance."
