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Fractyl Health to Present Preclinical Proof-of-Concept Data for Rejuva® Pancreatic Gene Therapy Platform Program at the American Society of Gene & Cell Therapy Congress

LEXINGTON, Mass.–(BUSINESS WIRE)– Fractyl Health, an organ-editing metabolic therapeutics company focused on pioneering new approaches to the treatment of type 2 diabetes (T2D), announced today that it will be presenting two oral presentations describing its Rejuva® pancreatic gene therapy platform at the American Society of Gene & Cell Therapy (ASGCT) Congress from May 16-20, 2023, in Los Angeles, CA.

The first oral presentation, “A Pancreatic Gene Therapy Delivery Platform for the Treatment of Type 2 Diabetes,” abstract number 191, will be presented on Thursday, May 18, 2023, from 5:00 pm to 5:15 pm PDT. The session, “Metabolic, Storage, Endocrine, Liver, and Gastrointestinal Diseases II,” will take place in Room 403 AB. This presentation will provide new preclinical proof-of-concept efficacy data of Fractyl Health’s pancreatic gene therapy delivery platform with GLP-1 receptor analog-based gene therapy for T2D and obesity.

The second oral presentation, “Tissue-Restricted Promoter Selection as a Mitigation Strategy for Dorsal Root Ganglia Toxicity Due to AAV9 Treatment of Yucatan Pigs,” abstract number 312, will be presented on Saturday, May 20, 2023, from 8:00 am to 8:15 am PDT. The session, “Pharmacology/Toxicology Studies: In Vitro and In Vivo Safety,” will be held in Petree Hall C. This presentation will focus on Fractyl Health’s investigation of tissue-restricted promoter selection as a strategy to mitigate potential toxicity risks associated with AAV9-based gene therapy.

Fractyl Health further announced that the two oral presentations at ASGCT will follow on the heels of data presentations of its Rejuva program at a Keystone Symposium and at Digestive Disease Week (DDW) earlier in May. At Keystone Symposium, Fractyl Health presented data on progress identifying optimized, islet-targeted gene therapy candidates capable of improving pancreatic beta cell function in vitro and in preclinical models with localized GLP1-based gene therapy in the pancreas. At DDW, Fractyl Health presented initial large animal feasibility and proof-of-concept safety of its prototype medical device that may provide a novel route of administration for pancreatic gene therapy candidates directly to the pancreas.

“We are enthusiastic about sharing our latest findings and advancements in the field of pancreatic gene therapy at the upcoming ASGCT Congress,” said Dr. Harith Rajagopalan, CEO of Fractyl Health. “These presentations will showcase our progress in addressing the critical challenges required to enable gene therapy in the pancreas. Progress on our Rejuva program shows that we are committed to developing innovative solutions for T2D while carefully addressing potential safety concerns in gene therapy applications.”

About Fractyl Health

Fractyl Health is focused on pioneering new approaches to the treatment of T2D. Despite advances in treatment over the last 50 years, metabolic diseases in general, and T2D, in particular, continue to be a principal and rapidly growing driver of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform T2D treatment from chronic blood glucose management to disease-modifying therapies that target the organ-level root causes of the disease. Fractyl Health is a private organ-editing metabolic therapeutics company based in Lexington, MA. For more information, visit www.fractyl.com or www.twitter.com/FractylHealth

About Rejuva®

Rejuva® platform focuses on developing next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies for the treatment of T2D and other metabolic diseases. 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.

About ASGCT

The American Society of Gene & Cell Therapy (ASGCT) is a leading international organization for researchers, clinicians, and industry professionals dedicated to the advancement of gene and cell therapies. ASGCT’s annual congress brings together experts from around the world to discuss the latest developments in gene editing, gene therapy, stem cell therapy, and cell therapy. The event offers a platform for sharing groundbreaking research, fostering collaborations, and shaping the future of these rapidly evolving fields. More information can be found at www.asgct.org.

Contacts

Corporate

Lisa Davidson, Chief Financial Officer
Lisa@fractyl.com, 781.902.8800

Media

Beth Brett, Corporate Communications
Bbrett@fractyl.com, 720.656.6544