Fractyl Health receives FDA Breakthrough Device Designation for Revita in weight maintenance for people with obesity who discontinue GLP-1 based drugs

BURLINGTON, Mass., July 30, 2024 (GLOBE NEWSWIRE) — Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat the root cause of obesity and type 2 diabetes (T2D), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Company’s Revita System for use in the maintenance of weight loss after discontinuation of GLP-1 drugs. Breakthrough Device Designation will enable priority regulatory review with the FDA upon successful completion of the REMAIN-1 study, as well as the potential for an early or accelerated decision on reimbursement by the Centers for Medicare & Medicaid Services (CMS).

Revita is an outpatient endoscopic procedure that involves resurfacing the mucosal lining of the duodenum, the first part of the small intestine just after the stomach, which is responsible for breaking down food into absorbable nutrients. Revita targets the duodenal lining, which can become thickened by high-fat and high-sugar diets, making it hard for the body to maintain a healthy metabolism and blood glucose levels. By resurfacing and reversing the pathology of the duodenal lining, Revita, if approved, has the potential to become the first disease-modifying therapy that targets a root cause of obesity and T2D.

Obesity is a highly prevalent, complex disease that is associated with multiple cardiometabolic complications, including T2D. GLP-1 agonists have become game-changers in the treatment of diabetes and obesity: over 40% of patients with diabetes in the U.S. have tried GLP-1s and over 12 million U.S. adults have used them just to lose weight,^{1 2} yet they are not providing patients with sustained solutions to these chronic problems. Discontinuation rates are high due to gastrointestinal side effects, cost, access challenges, and other unexplained reasons. Clinical studies have highlighted the risk of substantial weight regain — as much as 66% — within one year of discontinuing GLP-1 drugs.^{3, 4}

To qualify for a Breakthrough Device Designation, a device technology must address an unmet need and show that it has the potential to provide for a more effective treatment of life-threatening diseases or irreversibly debilitating conditions. The goal of the program is to provide patients and clinicians with timely access to these Breakthrough treatments by accelerating their development, assessment and review while maintaining regulatory standards for pre-market approval.

“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. 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,” said Harith Rajagopalan, M.D., Ph.D., Co-founder and Chief Executive Officer of Fractyl. “We look forward to reporting data from our open-label study in weight maintenance in the fourth quarter of this year and anticipate a mid-point randomized analysis of the REMAIN-1 pivotal study in Q2 2025. We believe these data will provide further proof that Revita stands alone in the crowded obesity landscape and has the potential to change the treatment paradigm for the majority of patients who want a sustainable solution for their obesity.”

In prior clinical studies of Revita conducted in people with T2D in the U.S. and EU, pooled analyses of weight data provided evidence to support the potential for durable weight maintenance after a single Revita procedure. Revita is approved in Germany for the treatment of T2D and has both an FDA Breakthrough Device designation in insulin-treated T2D and reimbursement support from CMS, meaning that CMS will cover routine costs and certain study-related expenses for participants.

About Revita
Fractyl Health’s lead product candidate, Revita, is based on the company’s insights surrounding the potential role of the gut in obesity and T2D. Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e., duodenal mucosal resurfacing) to edit abnormal intestinal nutrient sensing and signaling mechanisms that are a potential root cause of metabolic disease. Revita has received a CE mark in Europe and, in January 2022, received reimbursement authorization through NUB in Germany for the treatment of T2D. In the United States, Revita is for investigational use only under US law. A pivotal study of Revita in patients with T2D who are inadequately controlled on any glucose lowering agent, REVITALIZE-1, is currently enrolling in the United States and Europe. A pivotal study of Revita in patients with obesity after discontinuation of GLP-1 based drugs, called REMAIN-1, is underway with anticipated data readouts from the open-label study in weight maintenance in the fourth quarter of 2024 and an anticipated mid-point randomized analysis of the REMAIN-1 pivotal study in Q2 2025.

About Fractyl Health
Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. Fractyl Health is based in Burlington, MA. 

Source: Globe Newswire