Fractyl Health to Present Compelling Preclinical Data from its Rejuva® Single-Administration Smart GLP-1 Pancreatic Gene Therapy Platform at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting

Rhea-AI Summary

Fractyl Health (Nasdaq: GUTS) announced an upcoming presentation of preclinical data for their innovative Rejuva Smart GLP-1 pancreatic gene therapy platform at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting in New Orleans.

Key highlights:

• The presentation focuses on a single-administration therapy targeting obesity and type 2 diabetes root causes
• Research title: "Endoscopic Ultrasound-Guided Delivery of Human Glucagon-like Peptide-1 Pancreatic Gene Therapy: Safety and Feasibility in a Porcine Model"
• Scheduled for May 17, 2025, at 9:15 AM CT in NOLA Theater A
• Part of the AAV Preclinical and Proof-of-Concept Studies session

The presentation materials will be accessible through the Presentations & Publications section of Fractyl's website after the event concludes on May 17, 2025.

Positive

• Planned presentation of preclinical data for Smart GLP-1 pancreatic gene therapy platform at major scientific conference (ASGCT)
• Development of innovative single-administration therapy targeting obesity and type 2 diabetes
• Company advancing novel endoscopic ultrasound-guided delivery method for gene therapy

Negative

• Data is only preclinical stage, indicating long pathway to potential commercialization
• Current studies limited to porcine (pig) models, showing early stage of development
• No efficacy data mentioned in the announcement

BURLINGTON, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (“the Company”), a metabolic therapeutics company focused on pattern-breaking approaches to treat the root causes of obesity and type 2 diabetes (T2D), today announced that it will deliver an oral presentation of compelling preclinical data from its Rejuva single-administration Smart GLP-1 pancreatic gene therapy platform at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting, taking place May 13-17, 2025, in New Orleans, Louisiana.

Oral Presentation Details:

Title: Endoscopic Ultrasound-Guided Delivery of Human Glucagon-like Peptide-1 Pancreatic Gene Therapy: Safety and Feasibility in a Porcine Model
Session: AAV Preclinical and Proof-of-Concept Studies
Date and Time: Saturday, May 17, 2025, 9:15 a.m. – 9:30 a.m. CT
Location: NOLA Theater A

The presentation will be available via the Presentations & Publications section of the Fractyl website once it concludes on May 17, 2025.

About Fractyl Health
Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. Fractyl Health is based in Burlington, MA. For more information, visit www.fractyl.com.

About Rejuva^®
Fractyl Health’s Rejuva platform focuses on developing next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies for the treatment of obesity and T2D. The Rejuva platform is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use. Rejuva leverages advanced delivery systems and proprietary screening methods to identify and develop metabolically active gene therapy candidates targeting the pancreas. The program aims to transform the management of metabolic diseases by offering novel, disease-modifying therapies that address the underlying root causes of disease. The Company plans to submit the first Clinical Trial Application (CTA) module for RJVA-001 in type 2 diabetes to regulators in H1 2025, and if the CTA is authorized, expects to report preliminary data in 2026.

Contacts 

Media Contact 
Jessica Cotrone, Head of Corporate Communications 
jcotrone@fractyl.com, 978.760.5622

Investor Contact
Brian Luque, Head of Investor Relations and Corporate Development
IR@fractyl.com, 951.206.1200

FAQ

What will Fractyl Health (GUTS) present at ASGCT 2025 Annual Meeting?

Fractyl Health will present preclinical data from its Rejuva single-administration Smart GLP-1 pancreatic gene therapy platform at ASGCT 2025 on May 17, 2025, in New Orleans.

When is Fractyl Health's (GUTS) presentation at ASGCT 2025?

Fractyl Health's presentation is scheduled for Saturday, May 17, 2025, from 9:15 AM to 9:30 AM CT at the NOLA Theater A in New Orleans.

What is Fractyl Health's (GUTS) new gene therapy treatment targeting?

Fractyl Health's gene therapy platform targets the root causes of obesity and type 2 diabetes through a pancreatic gene therapy approach using GLP-1.

How can investors access Fractyl Health's (GUTS) ASGCT 2025 presentation?

Investors can access the presentation through the Presentations & Publications section of Fractyl's website after it concludes on May 17, 2025.

What type of study is Fractyl Health (GUTS) presenting at ASGCT 2025?

Fractyl Health is presenting a porcine model study on endoscopic ultrasound-guided delivery of human glucagon-like peptide-1 pancreatic gene therapy, focusing on safety and feasibility.