Fractyl Health, Inc. (GUTS) announced that regulators in the Netherlands have authorized the company to initiate a Phase 1/2 first-in-human study of RJVA-001, its lead candidate from the Rejuva Smart GLP-1 gene therapy platform. This marks the first adeno-associated virus (AAV)-based gene therapy to enter clinical development for type 2 diabetes.
RJVA-001 is designed as a one-time, pancreas-targeted gene therapy that enables nutrient-responsive GLP-1 secretion directly from beta cells, potentially reducing the need for chronic systemic dosing associated with current GLP-1 drugs. The therapy will be delivered via minimally invasive endoscopic ultrasound-guided infusion into the pancreas.
Fractyl expects to dose the first patient and report preliminary data in the second half of 2026, pending site activation. The company emphasized that the program is fully funded within its existing cash runway into early 2027, with no changes to capital plans, extending beyond the anticipated REMAIN-1 pivotal data readout for Revita, which is in late-stage development for post-GLP-1 weight maintenance.
CEO Harith Rajagopalan highlighted RJVA-001 as a potential breakthrough, noting that while GLP-1 medicines have transformed diabetes care, many patients struggle with long-term adherence to high-dose systemic therapy. RJVA-001 aims to provide a physiologic meal-triggered GLP-1 response through gene therapy.
This milestone advances Fractyl to a dual clinical-stage company, with Revita already in pivotal development for post-GLP-1 weight maintenance and Rejuva entering human trials for type 2 diabetes.
The company is scheduled to announce its Q1 2026 earnings call today at 4:00 p.m. ET, after market close.
GUTS has traded between $0.37 and $3.03 over the past year. The stock closed Monday's trading at $0.76, up 1.89%. In pre-market trading, the stock is at $0.80, up 5.29%.
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