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Fractyl Health, Inc. (NASDAQ:GUTS) (the Company), a metabolic therapeutics company focused on pattern-breaking approaches to treat the root causes of obesity and type 2 diabetes (T2D), today announced potent new preclinical data from RJVA-002, the second candidate from the Company's Rejuva® Smart GLP-1™ platform, at the 2025 Cell & Gene Meeting on the Mesa. The new data expand the potential of the Rejuva platform from the durable treatment of T2D to obesity.
RJVA-002 encodes both GIP and GLP-1 hormones, driven by an engineered human insulin promoter to enable beta cell-specific, nutrient-responsive expression. In a diet-induced obesity (DIO) mouse model with a humanized GIP receptor, a single administration of RJVA-002 led to ~30% weight loss over 5 weeks, with the weight loss trajectory not yet plateaued. No adverse effects were observed in treated animals. These results suggest potent and durable activity in the translationally relevant diet-induced model of obesity, supporting the platform's potential as a next-generation alternative to chronic drug therapy in obesity.
"These RJVA-002 data further support our Smart GLP-1 gene therapy platform approach and suggest that dual gut hormone expression has the potential to produce powerful metabolic effects," said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. "Together with the recently reported REMAIN-1 data, and with RJVA-001 nearing the clinic in 2026, these results underscore the strength and breadth of our portfolio. We are advancing a multi-modality strategy with the goal of transforming the treatment paradigm for obesity and T2D from chronic disease management toward the durable remission of disease."
In this ongoing preclinical study, male mice engineered to express a humanized GIP receptor (Biocytogen) were fed a 60% high-fat diet (HFD) to induce obesity and were then randomized into one of four treatment cohorts: vehicle control, RJVA-001 mid-dose, RJVA-002 mid-dose, and RJVA-002 high-dose (n=7 per group). All mice were continued on HFD for the duration of the study. Treatment with RJVA-002 resulted in a robust, dose-dependent reduction in body weight compared to vehicle control (Figure 1). By day 35, mice in mid- and high-dose cohorts had lost a mean of 18% (p<0.01) and 29% (p<0.0001) of their body weight after a single dose of RJVA-002, respectively (Figure 1).
Results from this ongoing study at longer time points and with associated metabolic measurements will be presented at an upcoming scientific congress.
Rejuva is Fractyl's gene therapy platform designed to enable long-term remission of T2D and obesity by durably reprogramming pancreatic islet cells to endogenously produce metabolic hormones. RJVA-001, the first Rejuva candidate, is expected to enter first-in-human clinical trials in 2026 for patients with inadequately controlled T2D. RJVA-002 expands the platform into obesity, targeting dual incretin biology with the goal of achieving durable, well-tolerated, weight loss from a single intervention.
Posted In: GUTS
