Fractyl Health presents preclinical data for RJVA-001 gene therapy; CTA submission expected June 2025

FRACTYL HEALTH, INC.

Single dose RJVA-001 in db/db mice reduced fasting blood sugar >200 mg/dL, increased fasting insulin >2-fold, prevented weight gain.
Systemic GLP-1 levels 10-20 pM, >5-fold lower than pharmacologic GLP-1 drugs (50-150 pM), potentially reducing side effects.
Nutrient-responsive GLP-1 secretion demonstrated in human beta cells and islets, mimicking natural hormone regulation.
Endoscopic ultrasound delivery in pigs achieved targeted pancreatic expression in <20 min with no observed toxicity.
First CTA module submission for RJVA-001 expected by June 2025; preliminary human data anticipated in 2026.

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