Fractyl Health Unveils New Rejuva Smart GLP-1 Pancreatic Gene Therapy Preclinical Data Highlighting Durable Potency and Safety with Limited Systemic GLP-1 Exposure at ASGCT 2025

Data suggests that single dose of RJVA-001 leads to durable metabolic improvements with low systemic GLP-1 exposure in db/db mouse model of T2D— potentially simultaneously addressing durability, adherence, and tolerability challenges seen with current GLP-1 drugs

Endoscopic ultrasound-guided delivery achieves targeted pancreatic expression in a large animal model with no toxicity observed to date

Data show nutrient-responsive GLP-1 secretion in human beta cells and human islets, demonstrating that Rejuva mimics natural hormone regulation rather than constant drug-driven stimulation

Rejuva advancing toward first-in-human studies; first CTA module submission for RJVA-001 expected by June 2025

BURLINGTON, Mass., May 17, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company), a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced an oral presentation of new preclinical data from its Rejuva smart GLP-1 gene therapy platform at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting. The data highlight RJVA-001’s potential to deliver durable, nutrient-responsive GLP-1 secretion from pancreatic beta cells—mimicking natural hormone regulation with low circulating levels of GLP-1, offering a potentially profound mechanistic advantage over pharmacologic GLP-1 drugs. RJVA-001 also showed strong efficacy, targeted delivery, and a favorable safety profile, reinforcing its readiness for first-in-human studies.

The data were featured in an oral presentation at ASGCT titled “Endoscopic Ultrasound-Guided Delivery of Human Glucagon-like Peptide-1 Pancreatic Gene Therapy: Safety and Feasibility in a Porcine Model.”

“RJVA-001 represents a fundamentally different approach to treating metabolic disease - one that delivers the power of GLP-1 in a more natural manner,” said Professor Randy Seeley, Ph.D., Henry King Ransom Professor of Surgery and Director of Michigan Nutrition Obesity Research Center at Michigan School of Medicine. “The ability to drive durable metabolic effects with physiologic hormone levels, from a one-time treatment, would be a scientific breakthrough with huge potential implications for patients. This has the potential to reshape how we think about treating T2D and obesity at scale.”