Fractyl Health Presented New Analysis from Pooled Data of Revita® Clinical Studies Demonstrating Durable Weight Loss Maintenance for One Year at ObesityWeek® 2024
Fractyl Health (Nasdaq: GUTS) presented new analysis from pooled data of Revita® clinical studies showing durable weight loss maintenance for one year. The analysis included 118 participants followed for 48 weeks post-Revita procedure. 90% of patients lost weight at one month, with 84% maintaining weight loss through one year without prescribed diet or lifestyle intervention. The study population had Type 2 Diabetes, with 62% having obesity and 34% being overweight. The Revita procedure, which resurfaces the duodenal lining, was well tolerated with no serious adverse events. The company expects to report pivotal trial data in Q4 2024.
Fractyl Health (Nasdaq: GUTS) ha presentato una nuova analisi dei dati aggregati degli studi clinici Revita® che mostrano una manutenzione durevole della perdita di peso per un anno. L'analisi ha incluso 118 partecipanti seguiti per 48 settimane dopo la procedura Revita. Il 90% dei pazienti ha perso peso dopo un mese, con l'84% che ha mantenuto la perdita di peso per un anno senza diete prescritte o interventi sullo stile di vita. La popolazione dello studio aveva il Diabete di Tipo 2, con il 62% in sovrappeso e il 34% obesi. La procedura Revita, che ripristina il rivestimento duodenale, è stata ben tollerata senza eventi avversi gravi. L'azienda prevede di riportare dati sui trial pivotal nel Q4 2024.
Fractyl Health (Nasdaq: GUTS) presentó un nuevo análisis de datos agrupados de estudios clínicos de Revita® que muestran un mantenimiento duradero de la pérdida de peso durante un año. El análisis incluyó a 118 participantes seguidos durante 48 semanas después del procedimiento Revita. El 90% de los pacientes perdió peso en un mes, y el 84% mantuvo la pérdida de peso durante un año sin una dieta prescripta ni intervención en el estilo de vida. La población del estudio tenía Diabetes Tipo 2, con el 62% con obesidad y el 34% con sobrepeso. El procedimiento Revita, que reestructura el revestimiento duodenal, fue bien tolerado sin eventos adversos graves. La compañía espera reportar datos de ensayos cruciales en el cuarto trimestre de 2024.
Fractyl Health (Nasdaq: GUTS)은 Revita® 임상 연구의 데이터 pooled 분석 결과를 발표하여 1년 동안의 지속적인 체중 유지 효과를 보여주었습니다. 이 분석은 Revita 시술 후 48주 동안 추적 관찰한 118명의 참가자를 포함했습니다. 환자의 90%가 1개월 내에 체중을 줄였으며, 84%는 처방된 식단이나 생활 습관 개입 없이 1년 동안 체중 감소를 유지했습니다. 연구 집단은 제2형 당뇨병을 앓고 있었으며, 62%가 비만, 34%가 과체중이었습니다. Revita 시술은 십이지장 내벽을 복원하며, 심각한 부작용 없이 잘 견뎌졌습니다. 회사는 2024년 4분기에 주요 임상 시험 데이터를 발표할 예정입니다.
Fractyl Health (Nasdaq: GUTS) a présenté une nouvelle analyse des données combinées des études cliniques Revita®, montrant un maintien durable de la perte de poids pendant un an. L'analyse a inclus 118 participants suivis pendant 48 semaines après la procédure Revita. 90 % des patients ont perdu du poids au bout d'un mois, et 84 % ont maintenu cette perte de poids pendant un an sans régime ni intervention sur le mode de vie prescrits. La population de l'étude souffrait de diabète de type 2, dont 62 % étaient obèses et 34 % en surpoids. La procédure Revita, qui restaure la muqueuse du duodénum, a été bien tolérée sans événements indésirables graves. L'entreprise prévoit de communiquer des données d'essai cruciales au quatrième trimestre 2024.
Fractyl Health (Nasdaq: GUTS) präsentierte eine neue Analyse der gepoolten Daten von Revita®-Klinikstudien, die eine nachhaltige Gewichtsreduktion über ein Jahr zeigen. Die Analyse umfasste 118 Teilnehmer, die 48 Wochen nach dem Revita-Verfahren verfolgt wurden. 90% der Patienten verloren Gewicht nach einem Monat, während 84% das Gewicht über ein Jahr ohne verordnete Diät oder Eingriffe in den Lebensstil halten konnten. Die Studienpopulation hatte Typ-2-Diabetes, wobei 62% übergewichtig und 34% fettleibig waren. Das Revita-Verfahren, das die Dünndarmwand erneuert, wurde gut vertragen und es gab keine schwerwiegenden Nebenwirkungen. Das Unternehmen plant, im 4. Quartal 2024 entscheidende Studiendaten zu melden.
- 90% of patients achieved weight loss at one month post-procedure
- 84% maintained weight loss through one year without intervention
- No device or serious adverse events reported
- FDA Breakthrough Device designation received for weight maintenance
- Well-defined timeline for pivotal trial data release in Q4 2024
- Study population to mostly hard-to-treat patients with T2D
- Results pending FDA approval for commercial use
Insights
The pooled data analysis from five clinical studies of Revita® presents significant implications for obesity and T2D treatment. The key findings show
The procedure's differentiated therapeutic profile - achieving rapid weight loss plateau after week four without requiring ongoing intervention - contrasts sharply with current GLP-1 medications that need extended dose titration and continuous use. The FDA Breakthrough Device designation for weight maintenance post-GLP-1 therapy discontinuation indicates strong potential for addressing a critical market gap.
However, investors should note that pivotal trial data is still pending, with key results expected in Q4 2024 for the REVEAL-1 cohort and Q2 2025 for REMAIN-1. The technology's commercial success will depend on these trial outcomes and eventual FDA approval.
Single Revita procedure led to sustained, clinically meaningful weight loss in majority of patients with Type 2 Diabetes
REMAIN-1 weight maintenance pivotal study on-track to report mid-point data analysis in Q2 2025
Company will report weight maintenance data after discontinuation of GLP-1 drugs in open-label REVEAL-1 cohort in Q4 2024
BURLINGTON, Mass., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), presented the poster, “Duodenal Mucosal Resurfacing (DMR) Durably Maintains Weight Loss in Metabolic Disease,” on Sunday, November 3, 2024, during The Obesity Society’s Annual Meeting at ObesityWeek 2024 in San Antonio, Texas.
The poster showcased compelling results of a pooled data analysis from five clinical studies, n=118, where participants were followed for 48 weeks post-Revita procedure. At baseline, prior to treatment, participants had longstanding, inadequately controlled T2D. Most had obesity (
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, if approved by the U.S. Food and Drug Administration (FDA), Revita has the potential to become the first disease-modifying therapy that targets a root cause of obesity and T2D.
“We are moving towards a new frontier in the treatment of obesity. While current GLP-1 drugs have helped patients lose weight, the critical unmet need is now how to durably keep this weight off,” said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl. “These data show that a single Revita procedure results in durable weight maintenance and holds the potential to advance the treatment of obesity by providing an off-ramp from GLP-1 therapies. We believe these data were valuable in the FDA Breakthrough Device designation granted to Revita for weight maintenance for people with obesity who discontinue GLP-1 drugs. This designation is only given to those technologies that address high unmet needs and may improve the lives of people with life-threatening or debilitating conditions. This validates the critical unmet need that Revita may be able to fill. We look forward to reporting data from our pivotal trial in weight maintenance in the fourth quarter of this year.”
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. For more information, visit www.fractyl.com or https://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 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.
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, including, without limitation, statements regarding the promise and potential impact of our preclinical or clinical trial data, the design, initiation, timing and results of clinical enrollment and any clinical trials or readouts, the content, information used for, timing or results of any IND-enabling studies or IND applications, the potential launch or commercialization of any of our product candidates or products, the sufficiency of our cash, cash equivalents, and investments to fund our operating activities for any specific period of time, and our strategic and product development objectives and goals, including with respect to enabling long-term control over obesity and type 2 diabetes without the burden of chronic therapies. 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 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 Company’s product candidates or products and our strategic and product development objectives and goals, and the other factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 14, 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
Jessica Cotrone, Corporate Communications
jcotrone@fractyl.com, 978.760.5622
Investor Contact
Stephen Jasper, Gilmartin Group
stephen@gilmartinir.com, 619.949.3681
FAQ
What were the key results of Fractyl Health's (GUTS) Revita clinical studies in 2024?
How does the Revita procedure work for weight loss maintenance?
When will Fractyl Health (GUTS) report their REMAIN-1 pivotal study results?
What regulatory status has Fractyl Health's (GUTS) Revita procedure received?
