BURLINGTON, Mass. - Fractyl Health, Inc. (NASDAQ:GUTS), a metabolic therapeutics company, has announced new preclinical findings for its GLP-1 gene therapy candidate, RJVA-001. The therapy, part of the Rejuva® pancreatic gene therapy platform, is designed to treat obesity and type 2 diabetes (T2D) and has shown significant potential in lowering blood sugar and body weight.
The study administered the human GLP-1 transgene sequence in RJVA-001 to eight-week-old db/db mice, a standard model for T2D clinical development. Results demonstrated up to a 50% reduction in blood sugar levels and 11% weight loss over four weeks with a single administration. This is compared to a 32% glucose reduction and 2% weight loss achieved with chronic semaglutide, a current treatment.
Dr. Timothy Kieffer, Chief Scientific Officer at Fractyl Health, stated that these findings bring them closer to Investigational New Drug (IND) enablement for RJVA-001. European regulators have agreed on the use of the db/db mouse model to support the submission of a Clinical Trial Application (CTA) in Europe.
Dr. Harith Rajagopalan, CEO of Fractyl Health, highlighted the need for advances in GLP-1 therapy and expressed the company's aim to change the trajectory of obesity and T2D with RJVA-001, potentially offering durable remission of metabolic diseases.
Fractyl Health plans to conduct IND-enabling toxicity studies throughout 2024 and intends to initiate First-in-Human clinical studies in 2025. The company is focused on transforming metabolic disease treatment from chronic management to durable disease-modifying therapies targeting root causes of disease.
The information in this article is based on a press release statement.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.