01:31 PM EDT, 03/12/2024 (MT Newswires) -- Fractyl Health ( GUTS ) said Tuesday new preclinical findings for its first clinical candidate, RJVA-001, in its Rejuva pancreatic gene therapy platform showed "promising" results.

The data provided glucose lowering and weight loss potency from pancreas-produced native human GLP-1, highlighting the capacity of pancreatic GLP-1 to provide metabolic control, the company said.

"We now observe that a single-dose administration of a human GLP-1 transgene (as in RJVA-001) can achieve durable lowering of blood sugar and body weight compared to vehicle or chronic semaglutide administration in the well-validated db/db mouse model of diabetes," said Chief Scientific Officer Timothy Kieffer.

"We are one step closer to IND enablement for RJVA-001 as part of our broader preclinical development package," he added.

Fractyl said it plans to put RJVA-001 through toxicity studies in 2024 and start first-in-human trials in 2025.

The stock was down more than 10% in recent trading.

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