Fractyl Health Receives FDA IDE Approval for the Revita® Remain-1 Pivotal Study of Weight Maintenance in Obesity after Discontinuation of GLP-1 Based Drugs
- FDA approval obtained for pivotal Investigational Device Exemption (IDE) for Revita study by Fractyl Health, Inc.
- Remain-1 trial set to commence in the second half of 2024 to evaluate Revita's efficacy in maintaining weight loss post discontinuation of GLP-1RA drug therapy.
- Revita aims to address the unmet need for durable weight maintenance after stopping GLP-1 based drugs in obese individuals.
- Study to include randomized, double-blind trial comparing Revita versus sham in patients who have lost at least 15% total body weight on tirzepatide therapy.
- Revita procedure targets duodenum to reverse pathology linked to obesity and T2D, with potential for lasting weight maintenance shown in prior clinical studies.
- At least 315 subjects to be randomized 2:1 to Revita or sham, with primary objectives focusing on percent change in body weight and maintenance of weight loss post tirzepatide discontinuation.
- Fractyl Health aims to provide new therapeutic strategies for durable weight maintenance after stopping GLP-1 based drugs, addressing the evolving needs in obesity treatment.
- None.
Insights
As an endocrinologist, the announcement of Fractyl Health's FDA IDE approval for the study of Revita is a significant step forward in obesity management. The current landscape of obesity treatment is heavily reliant on pharmacotherapy with GLP-1 receptor agonists (GLP-1RAs) such as semaglutide and tirzepatide. These medications have shown efficacy in inducing substantial weight loss. However, the challenge of weight regain after discontinuation is a clinical hurdle that has not been adequately addressed.
The Remain-1 study's focus on weight maintenance post GLP-1RA discontinuation could fill a critical gap in sustainable obesity management. The duodenal mucosal resurfacing procedure, Revita, has shown promise in prior studies for its potential to induce metabolic changes that could contribute to weight maintenance. If successful, this could alter the treatment paradigm by providing a non-pharmacologic option to sustain weight loss, potentially reducing the long-term risk of obesity-related complications such as type 2 diabetes and cardiovascular diseases.
From an economic perspective, the IDE approval for the Remain-1 study is poised to have substantial implications on healthcare costs associated with obesity and type 2 diabetes (T2D). Obesity is a precursor to numerous chronic conditions that are not only detrimental to patient health but also contribute significantly to rising healthcare expenditures. The direct and indirect costs of obesity-related complications are a financial strain on both public and private healthcare systems.
Should the Revita procedure prove effective in maintaining weight loss, it could lead to a reduction in the necessity for long-term pharmacotherapy, which can be costly. Additionally, by potentially mitigating the progression of obesity-related diseases, Revita could decrease overall healthcare costs. It's important to analyze the cost-effectiveness of Revita compared to existing obesity management strategies to fully understand its economic impact.
The FDA's IDE approval for Fractyl Health's Remain-1 study represents a notable milestone in the field of medical devices for obesity intervention. The device in question, Revita, operates on a novel principle of duodenal mucosal resurfacing, which is quite distinct from the pharmacological approaches currently dominating the market. The primary objectives of the study not only aim to prove the efficacy of Revita but also to establish its superiority over a sham procedure, which is a rigorous standard in clinical trial design.
For stakeholders, the success of Revita could mean a diversification of treatment options and a potential shift in market dynamics. The medical device sector could see an increased interest in endoscopic solutions for metabolic diseases, which may stimulate innovation and investment in this area. However, the long-term success of Revita will depend on the outcomes of the Remain-1 study, regulatory hurdles, market adoption and reimbursement policies, which are all factors that must be closely monitored.
Revita aims to be the first approved therapeutic option for durable weight maintenance after discontinuation of GLP-1 based drugs, as an adjunct to diet and exercise
With this FDA IDE approval, Fractyl Health will initiate the Remain-1 randomized, double blind pivotal study and begin providing updates on the open label cohort, which we refer to as the Reveal-1 cohort, in the second half of 2024
BURLINGTON, Mass., April 01, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced U.S. Food and Drug Administration (FDA) approval of a pivotal Investigational Device Exemption (IDE) to study Revita’s efficacy in maintaining weight loss following the discontinuation of GLP-1 receptor agonist (GLP-1RA) drug therapy, addressing a key unmet need in the treatment of obesity. Obesity affects over
The IDE approval launches the groundbreaking Remain-1 study, set to begin in the second half of 2024. Remain-1 is a randomized, double-blind trial of Revita versus sham in patients who have lost at least
The rationale for the Remain-1 pivotal study is based on a new need for therapeutic solutions that can offer durable weight maintenance without ongoing medical therapy. Highly potent drugs in the GLP-1RA class, including semaglutide (Wegovy®) and tirzepatide (Zepbound®), are now approved for the management of obesity and have dramatically altered the treatment landscape. However, real world studies report high discontinuation rates and clinical trials have indicated the risk of substantial weight rebound after discontinuation in many participants. Strategies to maintain weight loss independent of ongoing medical therapy could provide substantial clinical and economic benefits by extending the value of GLP-1RA drugs even after these medicines are discontinued.
“The unmet need in obesity is shifting from ‘How do we help people lose weight?’ to ‘How do we help people keep the weight off?’” said Christopher Thompson, MD MSc, Director of Endoscopy at Brigham and Women’s Hospital, Co-Director, Center for Weight Management and Wellness at Brigham Health, and Professor of Medicine at Harvard Medical School. “We now need new therapeutic strategies that can offer durable weight maintenance, and I am excited for the prospect of the Remain-1 pivotal study to hopefully address this massive challenge in obesity today.”
Revita is an outpatient endoscopic procedure that targets the duodenum and is designed to reverse pathology in the duodenal lining that is a root cause of obesity and T2D. In prior clinical studies of Revita conducted in people with T2D in the US and EU, pooled analyses of weight data provided evidence to support the potential for durable weight maintenance after a single Revita procedure.
The patient population for Remain-1 will consist of obese individuals with a BMI ≥ 30 kg/m^2. These GLP-1RA-naïve individuals will initiate tirzepatide therapy, titrated to achieve at least a
The primary objectives of the study are
- to demonstrate that Revita is superior to sham in percent change in body weight from baseline to week 24, and
- to demonstrate that a majority of Revita participants maintain clinically significant weight loss after discontinuing tirzepatide therapy.
"We believe there is substantial clinical and economic value in new approaches to obesity that can enable durable weight maintenance after stopping GLP-1 based drugs," said Dr. Harith Rajagopalan, CEO of Fractyl Health. "We were very happy to work collaboratively with key advisors in obesity and gastrointestinal endoscopy by rapidly developing this protocol to address a huge, emergent unmet need in the field."
About Fractyl Health
Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including T2D and obesity. Despite advances in treatment over the last 50 years, T2D and obesity 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. For more information, visit www.fractyl.com or www.twitter.com/FractylHealth.
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 inadequately controlled T2D despite multiple medicines and insulin, called Revitalize-1, is currently enrolling in the United States and Europe.
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 matters of historical fact should be considered forward-looking statements. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the Company’s limited operating history; the incurrence of significant net losses and the fact that the Company expects to continue to incur significant net losses for the foreseeable future; the Company’s need for substantial additional financing; the Company’s ability to continue as a going concern; the restrictive and financial covenants in the Company’s credit agreement; the lengthy and unpredictable regulatory approval process for the Company’s product candidates; uncertainty regarding its clinical studies; the fact that the Company’s product candidates may cause serious adverse events or undesirable side effects or have other properties that may cause it to suspend or discontinue clinical studies, delay or prevent regulatory development, prevent their regulatory approval, limit the commercial profile, or result in significant negative consequences; the Company’s reliance on third parties to conduct certain aspects of the Company’s preclinical studies and clinical studies; the regulatory approval process of the FDA, comparable foreign regulatory authorities and notified bodies, are lengthy, time-consuming and inherently unpredictable, and even if we complete the necessary clinical studies, we cannot predict when, or if, we will obtain regulatory approval or certification for any of our product candidates, and any such regulatory approval or certification may be for a more narrow indication than we seek; and the potential launch or commercialization of any of product candidates or products and our strategic and product development objectives and goals. 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, including the factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and in our other filings with the SEC. These forward-looking statements are based on management's current estimates and expectations. While 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 its views to change.
Contacts
Corporate Contact
Lisa Davidson, Chief Financial Officer
ir@fractyl.com, 781.902.8800
Media Contact
Beth Brett, Corporate Communications
Bbrett@fractyl.com, 720.656.6544
Investor Contact
Stephen Jasper
Gilmartin Group
stephen@gilmartinir.com, 619.949.3681
FAQ
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