Fractyl Health has announced new weight maintenance and blood sugar clinical results from the Company’s German Real-World Registry for the first 11 patients who have completed at least 12 months of post-Revita procedure follow-up.
At 12 months, the patients’ median weight decreased from 111 kilograms (245 pounds) to 97 kilograms (214 pounds), representing a nearly 13% total body weight loss, and their median HbA1c decreased from 9.6% to 7.2%. In addition, the number of glucose lowering medications remained stable or decreased for 10 out of the 11 patients at 12 months.
It is important to note that weight loss was observed as early as 1-month post-Revita procedure, and weight loss was generally maintained through 1 year of follow-up, which demonstrates in a real-world setting the potential for a single Revita procedure to be a durable weight maintenance solution. Revita was well tolerated in these patients, and no procedure-related adverse safety events were observed.
“These are compelling initial results for one of the hardest to treat patient populations – older people living with obesity and uncontrolled T2D. These one-year post-procedure data confirm and build upon what we have seen from Revita in earlier clinical studies. What I am most impressed with is the magnitude of continued, sustained weight loss and blood sugar improvement these patients experienced despite multiple prior efforts via other means. This contrasts with the diminishing effectiveness of medicines over time due to non-adherence and other real-world issues,” said Professor Stephan Martin, Director of the West German Diabetes Center of Excellence, Düsseldorf, Germany. “From what I have seen, I believe patients with obesity and T2D who are looking for an alternative to ongoing medication escalation should consider Revita in conjunction with a diet and exercise program to potentially change the trajectory of their disease. These data show that using Revita in this way could break the pattern of chronic medication and shift the treatment paradigm for obesity and T2D.”
“Patients deserve a life free from disease, and these data show that Revita has the potential to offer a profound new option to lighten the burden for people living with obesity and/or T2D,” said Dr Harith Rajagopalan, Co-founder and Chief Executive Officer of Fractyl. “Further, we are reassured by how well-tolerated the procedure has been in real-world use and by the strength and durability of the clinical effects we have seen thus far. We continue to be encouraged as we ramp up our REMAIN-1 study for Revita in weight maintenance, which recently received FDA Breakthrough Device designation, and as we continue enrolment in our REVITALIZE-1 study in T2D. We look forward to helping patients find a sustained solution for their obesity and T2D.”
To date, 37 patients have been treated with Revita in Germany and 31 have consented to participate in the Real-World Registry. Periodic updates on the Registry and clinical outcomes will be shared as the study continues to expand and enrol. Additional registry data from a larger number of patients will be presented at a scientific congress later this year.
Revita is an outpatient endoscopic procedure designed to resurface the mucosal lining of the duodenum, the first part of the small intestine just after the stomach, which is responsible for nutrient sensing and signalling from the gut to the brain and rest of the body. The duodenal lining can become thickened and dysfunctional by high-fat and high-sugar diets, making it hard for the body to maintain a healthy weight and blood glucose levels. By resurfacing and reversing the pathology of the duodenal lining, Revita, if approved, has the potential to become the first disease-modifying therapy that targets a root cause of obesity and T2D.
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 US, Revita is for investigational use only under US law. It has US FDA Breakthrough Device designation in weight maintenance for people with obesity who discontinue GLP-1 based drugs, as well as in insulin-treated T2D.
A pivotal study of Revita in weight maintenance for 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 analysis of the REMAIN-1 in Q2 2025. 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 US and Europe.
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