Tuesday, Fractyl Health Inc ( GUTS ) released new preclinical findings for the first clinical candidate in its Rejuva pancreatic gene therapy platform. 

RJVA-001 is the company’s first GLP-1 gene therapy candidate to emerge from the platform, setting the stage for a potentially transformative approach to treating metabolic diseases, including obesity and T2D.

Related Content: Weight-Loss Drug Gold Rush Gets Larger As New Player Fractyl Health Files For $100M IPO.

“As we advance our Rejuva program through preclinical development, 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 Timothy Kieffer, Fractyl Health ( GUTS ) Chief Scientific Officer. “With these data, we are one step closer to IND enablement for RJVA-001 as part of our broader preclinical development package.”

Novo Nordisk A/S’s breakthrough semaglutide is marketed as Wegvoy for weight loss and Ozempic for diabetes.

These results show that the human GLP-1 coding sequence of RJVA-001 demonstrates potency on glucose lowering and weight loss in db/db mice, the standard rodent T2D efficacy model used for clinical development. 

The company has aligned with European regulators to use this efficacy model to support submitting a clinical trial application in Europe.

Fractyl Health ( GUTS ) anticipates progressing RJVA-001 through IND-enabling toxicity studies in 2024 and initiating First-in-Human clinical studies in 2025.

Fractyl Health’s lead candidate, the Revita DMR System, is an outpatient procedural therapy designed to modify duodenal dysfunction. 

Revita is approved for patients with inadequately controlled type 2 diabetes in Europe. 

Price Action: GUTS shares are down 10.9% at $7.06 on the last check Tuesday.

Illustration of Phrama lab worker created with MidJourney.