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Fractyl Health Authorized to Initiate First-in-Human Trial of RJVA-001 in the Netherlands: First Gene Therapy Candidate to Enter Clinical Development for Type 2 Diabetes
Authorization advances Fractyl Health to a dual clinical-stage company, with Revita® in pivotal development for post-GLP-1 weight maintenance and Rejuva®
About this update from Fractyl Health, Inc.
[{"type":"text","content":"Authorization advances Fractyl Health to a dual clinical-stage company, with Revita® in pivotal development for post-GLP-1 weight maintenance and Rejuva® entering first-in-human studies for type 2 diabetes First-in-human dosing and preliminary data expected in the second half of 2026, subject to site activation Rejuva® clinical development funded within existing cash runway into early 2027, beyond anticipated REMAIN-1 Pivotal data readout; no change to capital plans BURLINGTON, Mass., May 11, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced that it has received Clinical Trial Application authorization in the Netherlands to initiate the Phase 1/2 first-in-human study of RJVA-001, the first clinical candidate from the Company’s Rejuva® Smart GLP-1™ gene therapy platform. With this authorization, Fractyl believes RJVA-001 is the first adeno-associated virus (AAV)-based gene therapy candidate to enter clinical development for T2D, and Fractyl now advances to a dual clinical-stage company, with Revita® in pivotal development for post-GLP-1 weight maintenance and Rejuva entering first-in-human studies for T2D in the Netherlands. Pending site activation, Fractyl expects to dose the first patient with RJVA-001 and report preliminary data in the second half of 2026. RJVA-001 is a one-time, beta-cell–targeted gene therapy designed to enable nutrient-responsive, physiologic GLP-1 expression within the pancreas, potentially avoiding the high circulating drug levels that contribute to side effects seen with systemic GLP-1 therapy. RJVA-001 is delivered via a minimally invasive endoscopic ultrasound-guided infusion directly into the pancreas, where it harnesses a proprietary, engineered version of the human insulin promoter and trafficking signals to drive nutrient-triggered secretion of GLP-1 from transduced pancreatic beta cells. \"GLP-1 medicines have changed what is possible in obesity and type 2 diabetes, but they require chronic, high-dose systemic exposure that many patients cannot or do not sustain. RJVA-001 takes a different path: a potential one-time, pancreas-targeted gene therapy designed to enable the body to produce GLP-1 in response to meals: phy...