Fractyl Health Presents New Preclinical Data on Sustained Weight Maintenance and Improved Body Composition from its Rejuva® Single-Administration GLP-1 Pancreatic Gene Therapy in President’s Select Oral Presentation at the American Diabetes Association’s 84th Scientific Sessions
Single administration of Rejuva reduced fat mass and improved glycemia in the well-validated diet-induced obesity (DIO) mouse model
Rejuva also prevented weight and glycemic rebound after semaglutide withdrawal
Data provide first demonstration that Rejuva treatment has potential to mimic natural release of GLP-1 from pancreas
BURLINGTON, Mass., June 23, 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 presented new data from its preclinical Rejuva pancreatic gene therapy program in an oral presentation at the American Diabetes Association (ADA)’s 84th Scientific Sessions in Orlando, FL. The presentation titled “Single-Dose GLP-1-Based Pancreatic Gene Therapy Durably Maintains Body Composition and Glycemia After Semaglutide Withdrawal in a Murine Model of Obesity,” and was chosen as noteworthy and one of eight President’s Select Abstracts at ADA this year.
Rejuva is the Company’s adeno-associated virus (AAV)-based GLP-1 pancreatic gene therapy program (PGTx), designed to enable durable production of GLP-1 in the pancreas for the treatment of obesity and T2D. The study presented at ADA compared the effects of a single dose of Rejuva and daily semaglutide treatment on body composition and glycemic parameters in the well-validated mouse model of diet-induced obesity (DIO). It also examined the effects of single-dose Rejuva in the DIO mice after semaglutide was discontinued.
“These data demonstrate that Rejuva can durably improve body composition and fasting glucose, compared to or better than semaglutide, by restoring GLP-1 production in a ‘one-and-done’ treatment,” said Harith Rajagopalan, M.D., Ph.D., co-founder and Chief Executive Officer of Fractyl. “These data also show Rejuva could help maintain improvements after semaglutide is withdrawn, highlighting our therapy’s potential to fill an emerging and critical need in the management of obesity and T2D: a reliable, ‘off ramp’ from chronic GLP-1 drugs that allows people to maintain the weight loss and blood sugar benefits, even as they stop taking these medicines.”
In the study presented at ADA, obese (DIO) mice were randomized 1:1:1 to one of the following and followed for 4 weeks:
- Arm 1: single administration of a Rejuva GLP-1-based gene therapy candidate,
- Arm 2: daily semaglutide injections, or
- Arm 3: placebo
At the end of 4 weeks, semaglutide was discontinued for mice in Arm 2 and those animals were further randomized 1:1 to receive either a single administration of the Rejuva gene therapy candidate or placebo, and all animals were followed for an additional 4 weeks, leading to the following assessment arms at 8 weeks:
- Arm 1: continued follow-up of a single administration of a Rejuva GLP-1-based gene therapy candidate
- Arm 2a: semaglutide withdrawal at week 4
- Arm 2b: semaglutide withdrawal with crossover to single administration Rejuva at week 4
- Arm 3: continued follow up of placebo
At the end of 8 weeks, the pancreatic islets were then isolated to study the effect of glucose exposure on GLP-1-based transgene release from genetically modified islets.
At week 4, the Rejuva arm experienced reduced fat mass of 21% versus 16% of body weight with semaglutide (both p