Breakthrough Device Designation is granted by the U.S. FDA to expedite the review of promising technologies that may address a high unmet need and improve the lives of people with life-threatening or debilitating conditions.
The REMAIN-1 pivotal trial to accelerate Revita’s path to a weight maintenance indication is ongoing, with data readout expected in Q4 2024.
BURLINGTON, Mass., July 30, 2024 (GLOBE NEWSWIRE) — Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches to treat the underlying causes of obesity and type 2 diabetes (T2D), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Company’s Revita System for use in maintaining weight loss after discontinuation of GLP-1 medications. Breakthrough device designation allows for priority regulatory review by the FDA upon successful completion of the REMAIN-1 trial and may increase the likelihood of an earlier or expedited decision on reimbursement by the Centers for Medicare and Medicaid Services (CMS).
Revita is an outpatient endoscopic procedure that regenerates the mucosal surface of the duodenum. The duodenum is the first part of the small intestine just after the stomach and is responsible for breaking down food into absorbable nutrients. Revita targets the duodenal lining, which can thicken with a high-fat, high-sugar diet, making it difficult to maintain a healthy metabolism and blood sugar levels. By regenerating the duodenal lining and reversing disease, if approved, Revita could be the first disease-modifying therapy to target the underlying causes of obesity and type 2 diabetes.
Obesity is a highly prevalent and complex disease with multiple cardiometabolic complications, including type 2 diabetes. GLP-1 agonists have become breakthrough drugs in the treatment of diabetes and obesity. Over 40% of US diabetic patients have tried GLP-1, and over 12 million US adults use GLP-1 for weight loss alone.1 2 However, patients are not offered a sustainable solution to these chronic problems. Discontinuation rates are high due to gastrointestinal side effects, cost, difficulty in access, and other unexplained reasons. Clinical studies have revealed a significant risk of weight gain of 66% within one year of discontinuing GLP-1 drugs.3, Four
To receive breakthrough device designation, a device technology must demonstrate the potential to address an unmet need and provide a more effective treatment for a life-threatening or irreversible debilitating condition. The goal of the program is to accelerate the development, evaluation and review of these breakthrough therapies while maintaining the regulatory standards of premarket approval, ensuring timely access for patients and clinicians.
“Patients who discontinue GLP-1 medications need a reliable off-ramp to maintain weight loss without having to continue taking these medications. The FDA’s breakthrough device designation validates Revita’s potential for these patients. We believe sustained weight maintenance is the greatest unmet need in obesity today, and Revita is one of the few investigational agents being evaluated in a pivotal study to test its potential for sustained weight maintenance,” said Harith Rajagopalan, MD, PhD, co-founder and chief executive officer of Fractyl. “We expect to report data from our open-label study of weight maintenance in the fourth quarter of this year, followed by a midpoint randomized analysis of the REMAIN-1 pivotal study in the second quarter of 2025. We believe these data will provide further evidence that Revita is unique among the obesity drug market and has the potential to change the treatment paradigm for the majority of patients seeking a sustainable solution to obesity.”
From previous clinical trials of Revita in patients with type 2 diabetes in the US and EU, a pooled analysis of weight data provided evidence supporting the potential for durable weight maintenance after a single Revita treatment. Revita is approved for the treatment of type 2 diabetes in Germany and has FDA Breakthrough Device Designation for insulin-treated type 2 diabetes, as well as reimbursement support from CMS, which means that participants’ day-to-day costs and certain study-related costs will be covered by CMS.
About Revita
Fractyl Health’s lead product candidate, Revita, is based on the company’s insights into the potential role of the gut in obesity and type 2 diabetes. Revita is designed to remodel the duodenal lining through hydrothermal ablation (i.e., duodenal mucosal resurfacing) and edit abnormal intestinal nutrient sensing and signaling mechanisms that are a potential underlying cause of metabolic disease. Revita has received CE Mark in Europe and received reimbursement approval through Germany’s NUB in January 2022 for the treatment of type 2 diabetes. In the United States, Revita is available for investigational use only under U.S. law. REVITALIZE-1, a pivotal study of Revita in patients with type 2 diabetes not adequately controlled with any glucose-lowering agents, is currently enrolling in the United States and Europe. Revita’s pivotal study, REMAIN-1, in obese patients following discontinuation of a GLP-1-based agent is currently ongoing, with data from the open-label study on weight maintenance expected in Q4 2024 and a midpoint randomized analysis of the REMAIN-1 pivotal study scheduled for Q2 2025.
About Fractil Health
Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and type 2 diabetes. Despite treatment advances over the past 50 years, obesity and type 2 diabetes remain the fastest growing causes of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform the treatment of metabolic diseases from chronic, symptomatic care to durable, disease-modifying therapies that target the root causes of disease at the organ level. Fractyl Health is based in Burlington, Massachusetts. For more information, please visit www.fractyl.com or https://twitter.com/FractylHealth.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to historical facts are deemed to be forward-looking statements, including, but not limited to, statements regarding the prospects and potential impact of preclinical or clinical trial data, the design, initiation, timing and results of clinical registration and clinical trials or readouts, the potential launch or commercialization of our product candidates or products, the potential therapeutic populations for our product candidates or products, and our strategy and product development objectives and goals, including enabling long-term management of obesity and type 2 diabetes without the burden of chronic treatment. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These include, but are not limited to, our limited operating history, the occurrence of significant net losses and the fact that we expect to continue to incur significant net losses for the foreseeable future, our need for substantial additional financing, our ability to continue as a going concern, the restrictive and financial covenants in our credit agreement, the lengthy and unpredictable regulatory approval process for our product candidates, uncertainties regarding our clinical trials, the fact that our product candidates may cause significant adverse events or undesirable side effects or have other characteristics that could result in the suspension or cessation of clinical trials, delay or prevention of regulatory developments, prevention of regulatory approval, limit our commercial profile or have other characteristics that could have a material adverse effect, our reliance on third parties to conduct certain aspects of our preclinical studies and clinical trials, the regulatory approval process with the FDA or comparable foreign regulatory authorities is lengthy, time-consuming and inherently unpredictable and, even if we complete the required clinical trials, we cannot predict when or if we will be able to obtain regulatory approval or certification for our product candidates, and any such regulatory approval or certification may be for a narrower indication than we seek. the potential launch or commercialization of our product candidates or products, our strategy and product development objectives and goals, and other factors discussed under the heading “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on May 13, 2024, and in our other filings with the SEC. These forward-looking statements are based on management’s current estimates and expectations. Although the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause our views to change.
contact address
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Lisa Davidson, Chief Financial Officer
email address781.902.8800
Media Contact
Jessica Cotrone, Corporate Communications
inquiry978.760.5622
Investor Contacts
Stephen Jasper, The Gilmartin Group
email address619.949.3681
1 https://www.kff.org/health-costs/poll-finding/kff-health-tracking-poll-may-2024-the-publics-use-and-views-of-glp-1-drugs/
2 U.S. Census Bureau data as of July 1, 2023
3 Wilding JPH et al. Diabetes Obes Metab. Weight gain and cardiometabolic effects after discontinuation of semaglutide: STEP 1 trial extension (2022).
Four Aron LJ et al. JAMATirzepatide Continuation Treatment for Maintenance of Weight Loss in Obese Adults: The SURMOUNT-4 Randomized Clinical Trial (2023).
