Fractyl Health, Inc. announced promising new preclinical findings for the first clinical candidate in its Rejuva®?pancreatic gene therapy platform. RJVA-001 is the Company?s first GLP-1 gene therapy candidate to emerge from the platform, setting the stage for a potentially transformative approach to treating metabolic diseases, including obesity and T2D. These results show that the human GLP-1 coding sequence of RJVA-001 demonstrates potency on both glucose lowering and weight loss in db/db mice, the standard rodent T2D efficacy model used for clinical development.

The Company has reached alignment with European regulators on the use of this efficacy model to support the submission of a Clinical Trial Application (CTA) in Europe. Fractyl Health anticipates progressing RJVA-001 through IND-enabling toxicity studies in 2024 and initiating First-in-Human clinical studies in 2025.