The data demonstrate for the first time the hypoglycemic and weight loss efficacy of native human GLP-1 produced in the pancreas and highlight the ability of pancreatic GLP-1 to provide metabolic control.
The human GLP-1 transgene sequence used in RJVA-001, when administered to 8-week-old db/db mice with established disease, reduced blood glucose levels by up to 50% compared to vehicle 4 weeks after a single dose. and an 11% weight loss occurred. Chronic semaglutide administration resulted in 32% glucose reduction and 2% weight loss compared to vehicle.
These results using the native short half-life human GLP-1 sequence used in RJVA-001 build on previous results using prototype transgene GLP-1 analogs.
BURLINGTON, Mass., March 12, 2024 (Globe Newswire) — Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”) is pioneering a new approach for the treatment of obesity and type 2 diabetes. We are a focused metabolic therapy company. (T2D) today announced promising new preclinical findings for Rejuva's first clinical candidate.® Pancreatic gene therapy platform. RJVA-001 is the company's first GLP-1 gene therapy candidate to emerge from this platform, setting the stage for potentially innovative approaches to treating metabolic diseases, including obesity and T2D.
“As we progress the Rejuva program through preclinical development, a single dose of the human GLP-1 transgene (similar to RJVA-001) achieves sustained reductions in blood glucose and body weight compared to vehicle or chronic semaglutide. It has been observed that administration under well-tested conditions decibel/decibel It’s a mouse model of diabetes,” said Dr. Timothy Kieffer, chief scientific officer at Fractyl Health. “These data move him one step closer to his IND of RJVA-001 as part of our extensive preclinical development package.”
These results demonstrate that the human GLP-1 coding sequence of RJVA-001 demonstrates efficacy in both hypoglycemia and weight loss. decibel/decibel Mice, the standard rodent T2D efficacy model used for clinical development. The Company has reached coordination with European regulatory authorities regarding 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 in weight loss, glycemic control, and overall metabolic health, therapeutic advances that will significantly advance GLP-1 therapy are still needed,” said Dr. Harris-Rajagopalan. , Representative Director of Fractyl Health. “Our goal with RJVA-001 is to change the trajectory of both obesity and T2D with a single-dose therapy that offers the potential for durable remission of metabolic diseases.”
Fractyl Health expects to advance RJVA-001 through IND-enabling toxicity studies in 2024 and begin first-in-human clinical studies in 2025.
About Fractyl Health
Fractyl Health is a metabolic therapy company focused on pioneering new approaches to treating metabolic diseases such as T2D and obesity. Despite treatment advances over the past 50 years, T2D and obesity continue to be rapidly increasing factors in morbidity and mortality in the 21st century. Fractyl Health's goal is to transform the treatment of metabolic diseases from chronic symptomatic treatments to sustained disease-modifying therapies that target the root causes of disease at the organ level. Fractyl Health is based in Burlington, Massachusetts. For more information, please visit: www.fractyl.com or www.twitter.com/FractylHealth.
About Rejuva
Fractyl Health Rejuva® This platform is focused on developing next-generation adeno-associated virus (AAV)-based locally delivered gene therapies for the treatment of T2D and obesity. The Rejuva platform is in preclinical development and has not yet been evaluated by any regulatory agency for clinical trials or commercial use. Rejuva leverages advanced delivery systems and proprietary screening methods to identify and develop metabolically active gene therapy candidates that target the pancreas. This program aims to transform the management of metabolic diseases by delivering new disease-modifying therapies that address the underlying root causes of the disease.
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to historical facts are deemed forward-looking statements. These statements are neither promises nor guarantees, but are subject to known and unknown risks and uncertainties, and which may cause our actual results, performance or achievements to be materially different from those expressed or implied. Contains other important factors that may cause the difference. Statements regarding statements including, but not limited to: our limited operating history; the incurrence of significant net losses and the fact that we expect to continue to incur significant net losses for the foreseeable future; The Company requires significant additional financing. our ability to continue as a going concern; Restrictive and Financial Covenants in Our Credit Agreement. lengthy and unpredictable regulatory approval processes for our product candidates; Uncertainties regarding clinical research. Our product candidates may cause serious adverse events or undesirable side effects or disrupt or discontinue clinical studies, delay or prevent regulatory development, preclude regulatory approval, limit our commercial profile; The fact that it has other characteristics that can cause consequences such as: Material Adverse Effect; additional time may be required to develop and obtain regulatory approval or certification for our Rejuva gene therapy candidate; our reliance on third parties to conduct certain aspects of our preclinical and clinical research; We rely on third parties to manufacture materials for our Rejuva gene therapy platform for preclinical studies and ongoing clinical studies. changes in the manufacturing or formulation methods of our Rejuva gene therapy candidate; In addition, contamination or interruptions in the manufacturing process for our Rejuva gene therapy candidate, shortages of raw materials, or the inability of our plasmid and viral suppliers to supply the required components could adversely affect the preclinical development and clinical development of our Rejuva gene therapy candidate. Development delays may occur. Or marketing schedule. These and other factors described under the caption “Risk Factors” in our prospectus filed with the Securities and Exchange Commission (“SEC”) on February 2, 2024 and other filings with the SEC. Important factors may cause actual results to differ. materially differ from those expressed in the forward-looking statements contained in this press release. Such forward-looking statements represent management's expectations as of the date of this press release. Although we may choose to update such forward-looking statements at some point in the future, we undertake no obligation to do so, even if subsequent events cause our views to change. .
contact address
Corporate contact
Lisa Davidson, Chief Financial Officer
ir@fractyl.com781.902.8800
media contact
Beth Brett, Corporate Communications
Bbrett@fractyl.com,720.656.6544
Investor contact information
stephen jasper
gilmartin group
stephen@gilmartinir.com619.949.3681
