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Fractyl Health Announces New Results From Its Rejuva® Platform Demonstrating Potent and Durable Effects of a Single Dose of a Human GLP-1 Pancreatic Gene Therapy Transgene Compared to Semaglutide in the db/db Mouse Model of Diabetes and Obesity
Data provides first demonstration of glucose lowering and weight loss potency from pancreas-produced native human GLP-1, highlighting the capacity of
About this update from Fractyl Health, Inc.
[{"type":"text","content":"Data provides first demonstration of 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 human GLP-1 transgene sequence used in RJVA-001 was administered to eight-week-old db/db mice with established disease and resulted in up to 50% blood sugar lowering and 11% weight loss vs vehicle at four weeks after a single administration, compared to 32% glucose lowering and 2% weight loss vs vehicle with chronic semaglutide. These results with a native, short half-life human GLP-1 sequence to be used in RJVA-001 build upon earlier results with a prototype transgene GLP-1 analogue. BURLINGTON, Mass., March 12, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced promising 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. “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 Dr. Timothy Kieffer, Fractyl Health 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.” These results show that the human GLP-1 coding sequence of RJVA-001 demonstrates potency on both glucose lowering and weight loss in db/db mice, the standard rodent T2D efficacy model used for clinical development. The Company has reached alignment with European regulators on the use of this efficacy model to support the submission of a Clinical Trial Application (CTA) in Europe. “While there are clear benefits of GLP-1 for weight loss, glucose control, and metabolic health in general, there remains a need for advances in care that can offer a major step forward in GLP-...