Fractyl Laboratories has announced the enrolment of the first patient in a pivotal clinical trial of Revita DMR (duodenal mucosal resurfacing) for patients with type 2 diabetes. The REVITA-T2Di trial will evaluate the ability of a single Revita DMR treatment to allow patients currently on insulin therapy but with inadequate glycaemic control to achieve durable insulin-free glycaemic control. Specifically, the trial will assess potential of outpatient Revita DMR treatment to eliminate need for daily insulin and is designed to form the basis for a marketing application to the FDA.
“We are pleased to initiate this global pivotal study of Revita DMR, a procedural therapy which we believe could significantly impact the lives of people living with type 2 diabetes whose blood sugar levels remain uncontrolled despite being on insulin therapy,” said Dr Harith Rajagopalan, co-founder and CEO of Fractyl. “In collaboration with clinical sites in the US and Europe, we look forward to evaluating Revita DMR in a segment of the type 2 diabetes population who are most at risk for hypoglycsemia, weight gain and other significant complications of insulin therapy.”
REVITA-T2Di (NCT #04419779) is a prospective, randomised, double-blind, sham-controlled study that is expected to enrol more than 300 patients at up to 35 sites in the US and Europe. It will evaluate the efficacy of Revita DMR, a first-in-class intervention targeting the role of the intestine in metabolic disease. The trial’s primary endpoint is the percentage of patients who are able to achieve target glycaemic control (HbA1c less than or equal to 7%) without the need for insulin at 24 weeks, comparing Revita DMR to the sham arm.
The trial has begun enrolling patients at its first clinical site at Indiana University Health, and additional trial sites will be announced in the coming months. More information about the study can be found at revitastudy.com.
“We would like to thank our investigators and partners for their collaboration in bringing this trial to patients whose only treatment option available today is insulin dose escalation,” said Dr Juan Carlos Lopez-Talavera, Chief Medical Officer of Fractyl. “By targeting the root cause of type 2 diabetes in the intestine, our preliminary clinical findings suggest that treatment with Revita DMR may be able to decrease insulin resistance. If these data are borne out in the REVITA-T2Di trial, Revita DMR may, in the future, represent an additional option for addressing the significant health and economic burden of type 2 diabetes for patients, healthcare systems, and society at large.”
Revita DMR is an outpatient endoscopic procedure, Revita DMR resurfaces the lining of the upper intestine (duodenal mucosa). During the minimally invasive technique, DMR is delivered via an integrated over-the-wire catheter attached to a custom console that performs a synchronised lifting of the duodenal mucosa and then ablation of the treatment area. Although the process is not yet fully understood, mucosal cells are believed to undergo alterations in a response to unhealthy diets that are high in fat and sugar. This leads to changes in the production and signalling of key hormones that impact insulin resistance and diabetes. Resurfacing the lining appears to rejuvenate and reset this process.
Revita DMR has been studied in clinical trials involving close to 300 patients. In April 2016, the Revita DMR System received a CE mark in the European Union. In the US, the device has not yet been authorized for marketing, but is the subject of an FDA-approved Investigational Device Exemption (IDE) study. The Revita DMR System may be available for investigational use in other regions.
Fractyl believes offer the potential to address other metabolic diseases in the future, including nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH), in an effort to reduce the global economic and healthcare burden of metabolic disease.