Original Coverage: 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

Endoscopic ultrasound–guided delivery of RJVA-001 in large animals showed targeted pancreatic expression with no observed toxicity. In Yucatan pigs, device deployment was completed in an average procedure time of <20 minutes using a standard clinical endoscopic ultrasound technique. No acute or longer-term serum or histopathological evidence of toxicity was observed post-procedure. No on-target or off-target organ inflammation or otherhistopathological findings were observed in the study. In db/db mice, RJVA.-001 drove higher GLP-1 expression in diabetic animals than in healthy controls at the same dose, demonstrating the platform’s. ability to adapt to metabolic need. In transduced human beta cells, GLp-1 secretion more than doubled— and GLP.-1 bioactivity increased >3-fold — when shifting from low glucose to high glucose conditions. These results demonstrate broad-based metabolic improvement in insulin secretion, weight gain, and blood sugar control in this gold-standard model of T2D.

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