Fractyl Health (GUTS) said Monday that it has submitted the first module of its clinical trial application in Europe for RJVA-001, a gene therapy candidate from its Rejuva platform targeting type 2 diabetes.
The metabolic therapeutics company said it expects to begin first-in-human dosing and share preliminary data next year, pending regulatory approval.
The upcoming phase 1/2 trial will assess safety, tolerability, and early efficacy in adults with poorly controlled type 2 diabetes, even while taking multiple glucose-lowering medications, including GLP-1 receptor agonists, the company said.
The study will consist of a dose-escalation phase followed by a potential expansion cohort, with participants receiving the gene therapy via endoscopic ultrasound-guided injection and being monitored for up to 12 months, as well as a five-year long-term follow-up, the company said.
Shares of the company rose nearly 3% in recent premarket activity on Monday.
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