Business
Fractyl Health Reports Second Quarter 2024 Financial Results and Provides Business Updates
Updated clinical results from German Real-World Registry demonstrate potential for Revita® to meaningfully sustain weight loss and lower blood sugar for at
About this update from Fractyl Health, Inc.
[{"type":"text","content":"Updated clinical results from German Real-World Registry demonstrate potential for Revita® to meaningfully sustain weight loss and lower blood sugar for at least one-year post-treatment in a real-world setting Granted U.S. FDA Breakthrough Device designation for Revita in weight maintenance after discontinuation of GLP-1 based drugs REMAIN-1 pivotal study for Revita in weight maintenance now initiated with anticipated data readouts beginning in Q4 2024 REVITALIZE-1 on-track to report topline data in mid-2025 in expanded Type 2 Diabetes patient population Presented head-to-head preclinical data comparing Rejuva® versus semaglutide in #1 abstract at ADA 2024 Conference call today at 4:30 p.m. ET BURLINGTON, Mass., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (“the Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today reported its second quarter 2024 financial results and provided business updates. “GLP-1 drugs have demonstrated impressive results in clinical studies. However, we are seeing that a majority of patients stop taking GLP-1 drugs within one year of starting them and are at risk of rapid weight regain and loss of hard-won benefits,” said Harith Rajagopalan, M.D., Ph.D., Co-founder and Chief Executive Officer of Fractyl. “These limitations extend to almost all drugs in the class and has created an urgent need for a durable solution to weight maintenance for a growing number of patients. We are proud to be pioneers in addressing this unmet need, which led us to accelerate our Revita weight maintenance study, REMAIN-1. We believe the recent FDA Breakthrough Device designation for Revita underscores our differentiated approach to the weight maintenance problem and provides further validation for this platform. This quarter we were also pleased to share new preclinical data showing that our Rejuva GLP-1 pancreatic gene therapy platform can durably improve body composition and blood sugar compared to semaglutide, and prevent weight regain after stopping semaglutide. This abstract was chosen as the top submission at this year’s American Diabetes Association (ADA)’s meeting.” Dr. Rajagopalan continued, “Across the Company, we have had strong execution through the first half of the year and are now entering what ...