Fractyl Health Provides Initial Clinical Update on Open-Label REVITA-T2Di

• REVITA-T2Di is an open-label cohort evaluating Revita DMR^® in patients with insulin-treated type 2 diabetes
• Revita^® in the T2Di cohort has been observed to be well tolerated and all patients previously on long-acting insulin have discontinued insulin therapy in the initial follow-up period
• Regular updates on the extended follow-up of the REVITA-T2Di cohort in comparison to population-matched controls are planned, alongside previously announced pivotal and controlled Revitalize T2D program studies

Fractyl Health, an organ-editing metabolic therapeutics company focused on pioneering a new approach to the treatment of type 2 diabetes (T2D), announced today initial interim feasibility data from human clinical experience in its REVITA-T2Di (T2Di) long-term open-label cohort. Revita has previously obtained Breakthrough Device Designation from the FDA to improve glycemic control and eliminate insulin needs in T2D patients who are inadequately controlled on long-acting insulin. In T2Di, clinical assessments observed in eight treated patients followed through at least four weeks demonstrated no adverse events of special interest (AESI) and all patients have discontinued insulin therapy in the initial follow-up period.

"We are thrilled to be participating as a leading center in the Revitalize T2D program,” said Carlos Galvani, M.D., Professor and Chief Division of Minimally Invasive Bariatric Surgery at Tulane University. “We are encouraged by our initial clinical experience with Revita in our patients and look forward to longer-term outcomes as well as our efforts in the ongoing Revitalize-1 pivotal study.”

About REVITA-T2Di

Ten subjects were enrolled in the T2Di cohort. One subject was found to have an intercurrent condition and was excluded at the time of endoscopy. Nine subjects were therefore treated with Revita. The baseline characteristics of the T2Di patients are as follows:

Prior to study procedure, all antidiabetic agents other than metformin and basal insulin were washed out for at least eight weeks, followed by an additional four-week run-in period. Post-Revita procedure, all patients discontinued their insulin and received only metformin and empagliflozin. Patients were closely monitored for glucose control; pre-specified criteria for insulin re-introduction will be followed to assess for the safety and effectiveness of glucose control.

All nine procedures were successfully completed across four treating centers by five different endoscopists, including three endoscopists new to Revita as part of this trial. Average procedure time was less than one hour in this outpatient endoscopic procedure.

In the nine treated subjects, there have been no device- or procedure-related Serious Adverse Events (SAEs) and no AESI (such as nausea, vomiting, or diarrhea, as defined in conjunction with the FDA). One subject who did not tolerate empagliflozin therapy withdrew from the study for reasons that were not related to Revita.

As of January 10, 2022, 100% of the eight patients with at least 4 weeks of follow-up remain off insulin and any other anti-diabetic agents they had previously been prescribed prior to enrollment, except for metformin and empagliflozin. Per protocol, insulin therapy will be re-introduced, if and when necessary, to help patients achieve good glycemic control.

“This early experience in REVITA-T2Di is preliminary, but beginning to demonstrate the potential feasibility and tolerability of Revita in patients with insulin-treated T2D who remain inadequately controlled. If ongoing studies are successful, it represents a potentially exciting treatment option to help achieve glycemic control in patients for whom the alternative would otherwise be insulin intensification,” said Vivian Fonseca, M.D., Chief of Endocrinology, Professor of Medicine and Pharmacology and Assistant Dean for Clinical Research at Tulane University.

“These encouraging early results from our REVITA-T2Di cohort build on our earlier clinical experience with Revita in nearly 300 patients, including the earlier INSPIRE pilot study testing Revita to help improve glucose control and eliminate use of insulin,” said Juan Carlos Lopez-Talavera, M.D., Ph.D., Chief Medical Officer of Fractyl Health. “We are encouraged by the technical success and patient tolerability profile we have seen thus far and impressed by the excellent clinical management of the patients at treating centers. While we do not expect that all patients will be able to successfully discontinue and remain off long-acting insulin therapy, we are encouraged by the initial experience thus far in this cohort and look forward to providing additional data as well as long-term comparisons to matched controls.”

About Revita^®

Fractyl Health’s lead product candidate, Revita, is based on the company’s insights surrounding the potential role of the gut in metabolic diseases. Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e., duodenal mucosal resurfacing) to edit abnormal intestinal nutrient sensing and signaling mechanisms that are a potential root cause of metabolic diseases. In April 2016, Revita received a CE mark in Europe. In the United States, Revita is for investigational use only and has received Breakthrough Device Designation from the FDA to improve glycemic control and eliminate insulin needs in T2D patients who are inadequately controlled on long-acting insulin.

About the Revitalize T2D Clinical Development Program

The Revitalize T2D program is a series of ongoing and planned clinical studies sponsored by Fractyl Health to investigate the potential utility of Revita in patients with, or at high risk for, T2D. The company’s ongoing pivotal clinical study, Revitalize-1, is designed as a randomized, double-blind crossover, sham-controlled, multi-center study in patients with inadequately controlled T2D despite being on metformin or multiple ADAs, and long-acting insulin. The T2Di cohort were the first ten enrolled subjects in Revitalize-1’s open-label stage 1 cohort who underwent a drug washout period that other subjects in the Revitalize-1 study will not undergo. The Revitalize-2 study is a planned profile optimization study in T2D patients who qualify for insulin and are failing guideline-directed therapy. The Revitalize-3 proof-of-concept pilot study is a planned study in patients with high-risk prediabetes to evaluate the effects of hydrothermal ablation of the duodenal mucosa using Revita to reduce the risk of developing T2D.

About Fractyl Health

Fractyl Health is focused on pioneering a new approach to the treatment of T2D. Despite advances in treatment over the last 50 years, metabolic diseases in general, and T2D in particular, continue to be a principal and rapidly growing driver of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform T2D treatment from chronic blood glucose management to disease-modifying therapies that target the organ-level root causes of the disease. Fractyl Health’s lead product candidate, Revita, is designed to remodel the duodenal lining via hydrothermal ablation (i.e., duodenal mucosal resurfacing) in order to edit abnormal intestinal nutrient sensing and signaling mechanisms that are a potential root cause of metabolic diseases. Fractyl Health is a private organ-editing metabolic therapeutics company based in Lexington, MA. For more information, visit www.fractyl.com or www.twitter.com/FractylHealth

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