Fractyl Health Receives Investigational Device Exemption from FDA for Revita Weight Loss Procedure

Metabolic therapeutics company, Fractyl Health (Nasdaq: GUTS) has received FDA approval of a pivotal Investigational Device Exemption (IDE) to study its lead product candidate, 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. Revita is an outpatient endoscopic procedure that is designed to reverse pathology in the duodenal lining that is a root cause of obesity and Type 2 diabetes (T2D).

Fractyl expects to launch its randomized, double-blind trial Remain-1 study in the second half of 2024. The study will evaluate Revita’s efficacy in patients who have lost at least 15% total body weight on tirzepatide therapy. The company will also initiate Reveal-1, an open-label cohort that will follow a similar patient population and management protocol with anticipated open-label data updates as the study progresses.

GLP-1 drugs have altered the treatment landscape for patients with obesity and T2D and there is a new unmet need for therapeutic solutions that can offer durable weight maintenance without ongoing medical therapy. Real world studies report high discontinuation rates and clinical trials have indicated the risk of substantial weight rebound after discontinuation in many participants.

“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.”

Obesity affects over 40% of the US population and is a critical precursor to chronic conditions such as type 2 diabetes, metabolic dysfunction-associated steatohepatitis (MASH), and cardiovascular disease.

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.

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Fractyl Health Receives Investigational Device Exemption from FDA for Revita Weight Loss Procedure

Catie Corcoran

Biotech Editor