Fractyl Health (GUTS) announced that it has submitted the first module of its Clinical Trial Application, CTA, in Europe for RJVA-001, the Company’s gene therapy candidate from its Rejuva platform. RJVA-001 is designed to express glucagon-like peptide-1, GLP-1, locally in pancreatic beta cells using nutrient-responsive control, potentially enabling physiologic hormone secretion without the high circulating levels that contribute to side effects seen with systemic GLP-1 drug therapy. Pending regulatory clearance, Fractyl anticipates initiating first-in-human dosing and reporting preliminary data in 2026.
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