Fractyl Health Updates on Revita® German Registry for Advanced T2D

Fractyl Health, Inc., a company specializing in metabolic therapeutics aimed at revolutionizing treatments for obesity and type 2 diabetes (T2D), has shared encouraging 6-month follow-up data from an ongoing German real-world registry study of its Revita treatment for T2D. The study involves 14 participants who have now experienced at least six months of post-treatment monitoring.

At the beginning of the study, the participants had a median age of 62 years and a median body weight of 111 kg. They were grappling with advanced T2D for an average of 14 years. Despite being on up to three glucose-lowering medications, their T2D was poorly controlled, as reflected by a median baseline HbA1c of 9.2%.

Following the Revita treatment, participants exhibited an average total body weight reduction of 8.1% at the six-month mark. This weight loss was not only significant but also generally sustained or improved from the first to the sixth month post-procedure. These findings underscore the potential of Revita for long-term weight loss maintenance.

Furthermore, fasting blood glucose levels among participants improved markedly, dropping from a median baseline of 153 mg/dL to 116 mg/dL at six months. HbA1c levels also showed improvement, decreasing from a median of 9.2% to 7.6%, indicating better glucose control. Importantly, these improvements were achieved even as patients either stabilized or reduced their use of glucose-lowering medications. To date, no serious adverse events related to the device or procedure have been reported.

Professor Stephan Martin, Director of the West German Diabetes Center of Excellence in Düsseldorf, Germany, recently presented the 3-month follow-up results of the Revita registry study at the German Diabetes Association annual meeting in Berlin. The center integrates Revita treatment with dietary and lifestyle support.

Timothy Kieffer, Chief Scientific Officer at Fractyl Health, emphasized the significance of these early results. He highlighted that the improvements in blood sugar levels, body weight, and medication burden are particularly noteworthy given that most participants had been struggling with advanced T2D for many years despite standard treatments. The sustained weight loss observed through six months further bolsters Fractyl Health's ongoing clinical development program focused on weight maintenance through the Remain-1 pivotal study.

Currently, 26 out of 33 participants treated with Revita in Germany have consented to join the Revita Registry. As the study continues to expand and enroll more participants, periodic updates on the clinical outcomes for patients undergoing Revita treatment in Germany will be provided.

Fractyl Health is committed to transforming the treatment paradigm for metabolic diseases, including obesity and T2D. The company aims to shift from chronic symptomatic management to durable, disease-modifying therapies that target the root causes of these conditions. Fractyl Health is based in Burlington, MA.

Revita, the company's leading product candidate, is designed to remodel the duodenal lining through hydrothermal ablation, potentially addressing abnormal nutrient sensing and signaling mechanisms that contribute to metabolic disease. While Revita has received CE mark approval in Europe and reimbursement authorization in Germany for T2D treatment, it is currently for investigational use only in the United States. The Revitalize-1 pivotal study for patients with inadequately controlled T2D is ongoing in the U.S. and Europe, with another study, Remain-1, set to begin in late 2024.

Additionally, Fractyl Health is advancing its Rejuva platform, which focuses on developing next-generation gene therapies for obesity and T2D. This platform is in preclinical development and aims to offer novel, disease-modifying treatments targeting the pancreas, leveraging advanced delivery systems and proprietary screening methods.