Fractyl Health Presents Compelling Preclinical Data from Single-Administration GLP-1 Pancreatic Gene Therapy Rejuva at Digestive Disease Week 2024

Results showed single-administration GLP-1 pancreatic gene therapy candidate reduced liver weight by 42% (p<0.01) and liver triglycerides by 67% (p<0.0001) compared to placebo two months after administration

Data also demonstrated reductions of 36% in total cholesterol and 51% in low density lipoprotein (LDL) cholesterol (both, p<0.0001) compared to placebo two months after administration

New results highlight potential for profound, durable, and broad metabolic benefit that can be achieved from single-administration GLP-1-based pancreatic gene therapy

BURLINGTON, Mass., May 20, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), presented new data from its preclinical Rejuva pancreatic gene therapy program as part of an oral presentation (abstract number 4029196) on Sunday, May 19^th, at Digestive Disease Week (DDW) 2024 in Washington, D.C.

“Metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction associated steatohepatitis (MASH) are the leading cause for liver transplant in the U.S. today. These diseases are caused by metabolic disease-associated accumulation of liver triglycerides and consequent liver inflammation. GLP-1-based drugs have demonstrated improved MASH in humans and are under investigation as a potential therapy for MASH. This is the first demonstration of a GLP-1-based pancreatic gene therapy (GLP-1 PGTx) on liver metabolic health in an obesity murine model – one that has strong potency, durable results, and a single administration,” said Harith Rajagopalan, M.D., Ph.D., co-founder and Chief Executive Officer of Fractyl. “These data potentially open the door to a curative intervention for MASLD/MASH that is accessible to gastroenterologists to perform. Fractyl plans to nominate its first GLP-1 PGTx candidate for obesity in the second half of 2024 and is eager to explore potential effects on MASLD/MASH.”

In the presentation titled “Single-Dose GLP-1-Based Pancreatic Gene Therapy Maintains Weight Loss After Semaglutide Withdrawal and Reduces Hepatic Triglycerides in a Murine Model of Obesity,” data showed that Rejuva reduced liver weight by 42% (p<0.01) and liver triglyceride content by 67% (p<0.0001) compared to placebo two months after administration.