The latest weight maintenance data from a pooled analysis of patients enrolled in Revita (Fractyl Health) clinical studies across the EU and US has revealed those who underwent the Revita procedure demonstrated a 3.4% (+/- standard deviation of 2.9; n=100) reduction in total body weight by Week 4, which increased to a 4.0% (+/- 5.0% standard deviation; n=94) reduction in total body weight by Week 48. These results were statistically significant, with p-values of <0.0001 for change from baseline at Week 4 and Week 48.
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 signalling mechanisms that are a potential root cause of metabolic disease.
The analysis interrogated patterns of weight change (a prespecified secondary endpoint in all included trials) in patients with inadequately controlled T2D on multiple glucose-lowering agents who have been followed through at least 48 weeks post-treatment with Revita.
In total, 157 participants were included in the analysis, with an average baseline weight of 93kg and a mean BMI of 31. Patients were on average 57 years of age with a T2D duration of ten years and baseline HbA1c of 8.3%. 118 of these subjects underwent Revita, and another 39 underwent a sham endoscopy procedure. Following the procedure, all subjects in both Revita and sham cohorts were prescribed a short post-procedure graduated diet and continued glucose lowering agents without further active lifestyle intervention.
Those who underwent a sham procedure showed a 2.1% (+/- 1.9% standard deviation; n=38) weight reduction at Week 4, but unlike in the Revita cohort, the initial weight loss in the sham arm was not sustained between Week 4 and Week 24, at which time sham subjects crossed over to Revita treatment.
“We now have potent GLP-1-based drugs that can induce weight loss while a patient is on therapy, but many patients would like to discontinue therapy without suffering from immediate weight regain,” said Dr John Amatruda, scientific advisor to Fractyl Health. “We therefore need interventions to help maintain weight loss in patients who cannot remain on chronic pharmacotherapy for the duration of their lives. These Revita results demonstrating sustained weight loss maintenance represent a promising potential approach to addressing this massive problem.”
“These new results in over 100 human subjects from our controlled clinical studies build on earlier data demonstrating that a single treatment with Revita can enable sustained weight maintenance in people who are at risk of weight gain,” said Dr Harith Rajagopalan, Fractyl Health Co-Founder and CEO. “The data raise the urgent question of whether Revita may help maintain weight in individuals who wish to discontinue GLP-1-based drugs, and we are eager to address this question in our ongoing clinical programme.”
Revita has received a CE mark in Europe and, in January 2022, received reimbursement authorization through NUB in Germany. In the US, 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 US and Europe.