Single administration of Rejuva decreased fats mass and improved glycemia within the well-validated diet-induced weight problems (DIO) mouse mannequin
Rejuva additionally prevented weight and glycemic rebound after semaglutide withdrawal
Knowledge present first demonstration that Rejuva therapy has potential to imitate pure launch of GLP-1 from pancreas
BURLINGTON, Mass., June 23, 2024 (GLOBE NEWSWIRE) — Fractyl Well being, Inc. (Nasdaq: GUTS) (the Firm), a metabolic therapeutics firm targeted on pioneering new approaches for the therapy of weight problems and kind 2 diabetes (T2D), at present offered new knowledge from its preclinical Rejuva pancreatic gene remedy program in an oral presentation on the American Diabetes Affiliation (ADA)’s 84th Scientific Periods in Orlando, FL. The presentation titled Single-Dose GLP-1-Based mostly Pancreatic Gene Remedy Durably Maintains Physique Composition and Glycemia After Semaglutide Withdrawal in a Murine Mannequin of Weight problems, and was chosen as noteworthy and certainly one of eight President’s Choose Abstracts at ADA this yr.
Rejuva is the Firm’s adeno-associated virus (AAV)-based GLP-1 pancreatic gene remedy program (PGTx), designed to allow sturdy manufacturing of GLP-1 within the pancreas for the therapy of weight problems and T2D. The examine offered at ADA in contrast the results of a single dose of Rejuva and each day semaglutide therapy on physique composition and glycemic parameters within the well-validated mouse mannequin of diet-induced weight problems (DIO). It additionally examined the results of single-dose Rejuva within the DIO mice after semaglutide was discontinued.
These knowledge reveal that Rejuva can durably enhance physique composition and fasting glucose, in comparison with or higher than semaglutide, by restoring GLP-1 manufacturing in a ˜one-and-done’ therapy, stated Harith Rajagopalan, M.D., Ph.D., co-founder and Chief Government Officer of Fractyl. These knowledge additionally present Rejuva may assist keep enhancements after semaglutide is withdrawn, highlighting our remedy’s potential to fill an rising and demanding want within the administration of weight problems and T2D: a dependable, ˜off ramp’ from persistent GLP-1 medicine that enables individuals to keep up the burden loss and blood sugar advantages, whilst they cease taking these medicines.
Within the examine offered at ADA, overweight (DIO) mice have been randomized 1:1:1 to one of many following and adopted for 4 weeks:
- Arm 1: single administration of a Rejuva GLP-1-based gene remedy candidate,
- Arm 2: each day semaglutide injections, or
- Arm 3: placebo
On the finish of 4 weeks, semaglutide was discontinued for mice in Arm 2 and people animals have been additional randomized 1:1 to obtain both a single administration of the Rejuva gene remedy candidate or placebo, and all animals have been adopted for an extra 4 weeks, resulting in the next evaluation arms at 8 weeks:
- Arm 1: continued follow-up of a single administration of a Rejuva GLP-1-based gene remedy candidate
- Arm 2a: semaglutide withdrawal at week 4
- Arm 2b: semaglutide withdrawal with crossover to single administration Rejuva at week 4
- Arm 3: continued comply with up of placebo
On the finish of 8 weeks, the pancreatic islets have been then remoted to review the impact of glucose publicity on GLP-1-based transgene launch from genetically modified islets.
At week 4, the Rejuva arm skilled decreased fats mass of 21% versus 16% of physique weight with semaglutide (each p
At week 8, fats mass rebounded to 1% beneath baseline (n.s.) within the semaglutide withdrawal group (Arm 2a), whereas semaglutide-withdrawn mice handled with Rejuva (Arm 2b) maintained fats discount of 17% (p
Glucose and insulin ranges in all intervention teams corresponded to adjustments noticed in fats mass, with statistically important enhancements in fasting glucose and fasting insulin in semaglutide-treated and Rejuva handled mice at 4 and eight weeks, however no enchancment in glucose or insulin in semaglutide-withdrawn mice that didn’t crossover to Rejuva at week 8.
Along with the compelling sturdiness of weight reduction, physique composition, and glucose enhancements seen on this mannequin, we’re happy that remoted, genetically modified islets from Rejuva-treated mice present this launch of GLP-1 in response to vitamins, stated Timothy Kieffer, Ph.D., Chief Scientific Officer of Fractyl. We consider this clearly demonstrates that Rejuva can mimic the physiologic launch of GLP-1 that happens naturally within the human physique.
About Fractyl Well being
Fractyl Well being is a metabolic therapeutics firm targeted on pioneering new approaches to the therapy of metabolic illnesses, together with weight problems and T2D. Regardless of advances in therapy over the past 50 years, weight problems and T2D proceed to be quickly rising drivers of morbidity and mortality within the twenty first century. Fractyl Well being’s purpose is to remodel metabolic illness therapy from persistent symptomatic administration to sturdy disease-modifying therapies that concentrate on the organ-level root causes of illness. Fractyl Well being is predicated in Burlington (NYSE:), MA. For extra data, go to‰www.fractyl.com‰or‰https://twitter.com/FractylHealth.
About Rejuva
Fractyl Well being’s Rejuva ®‰platform focuses on creating next-generation adeno-associated virus (AAV)-based, regionally delivered gene therapies for the therapy of weight problems and T2D. The Rejuva platform is in preclinical growth and has not but been evaluated by regulatory businesses for investigational or business use. Rejuva leverages superior supply techniques and proprietary screening strategies to establish and develop metabolically lively gene remedy candidates concentrating on the pancreas. This system goals to remodel the administration of metabolic illnesses by providing novel, disease-modifying therapies that handle the underlying root causes of illness.
Ahead-Trying Statements
This press release comprises forward-looking statements inside the that means of the Personal Securities Litigation Reform Act of 1995. All statements contained on this press release that don’t relate to issues of historic truth needs to be thought of forward-looking statements, together with, with out limitation, statements relating to the promise and potential affect of our preclinical or scientific trial knowledge, the design, initiation, timing and outcomes of scientific enrollment and any scientific trials or readouts, the content material, data used for, timing or outcomes of any IND-enabling research or IND functions, the potential launch or commercialization of any of our product candidates or merchandise, the sufficiency of our money, money equivalents, and investments to fund our working actions for any particular time period, and our strategic and product growth targets and objectives, together with with respect to enabling long-term management over weight problems and kind 2 diabetes with out the burden of persistent therapies. These statements are neither guarantees nor ensures, however contain identified and unknown dangers, uncertainties and different vital elements which will trigger the Firm’s precise outcomes, efficiency or achievements to be materially totally different from any future outcomes, efficiency or achievements expressed or implied by the forward-looking statements, together with, however not restricted to, the next: the Firm’s restricted working historical past; the incurrence of serious internet losses and the truth that the Firm expects to proceed to incur important internet losses for the foreseeable future; the Firm’s want for substantial further financing; the Firm’s potential to proceed as a going concern; the restrictive and monetary covenants within the Firm’s credit score settlement; the prolonged and unpredictable regulatory approval course of for the Firm’s product candidates; uncertainty relating to its scientific research; the truth that the Firm’s product candidates could trigger critical antagonistic occasions or undesirable unwanted effects or produce other properties which will trigger it to droop or discontinue scientific research, delay or stop regulatory growth, stop their regulatory approval, restrict the business profile, or lead to important adverse penalties; further time could also be required to develop and acquire regulatory approval or certification for the Firm’s Rejuva gene remedy candidates; the Firm’s reliance on third events to conduct sure points of the Firm’s preclinical research and scientific research; the Firm’s reliance on third events for the manufacture of the supplies for its Rejuva gene remedy platform for preclinical research and its ongoing scientific research; the regulatory approval strategy of the FDA, comparable overseas regulatory authorities and prolonged, time-consuming and inherently unpredictable, and even when we full the required scientific research, we can’t predict when, or if, we are going to get hold of regulatory approval or certification for any of our product candidates, and any such regulatory approval or certification could also be for a extra slim indication than we search; and the potential launch or commercialization of any of Firm’s product candidates or merchandise and our strategic and product growth targets and objectives, and the opposite elements mentioned beneath the caption Danger Components in our Quarterly Report on Kind 10-Q filed with the Securities and Change Fee (the SEC) on Might 13, 2024 and in our different filings with the SEC. These forward-looking statements are based mostly on administration’s present estimates and expectations. Whereas the Firm could elect to replace such forward-looking statements sooner or later sooner or later, the Firm disclaims any obligation to take action, even when subsequent occasions trigger its views to vary.
Contacts‰
Company Contact‰
Lisa Davidson, Chief Monetary Officer‰
ir@fractyl.com, 781.902.8800
Media Contact‰
Jessica Cotrone, Company Communications‰
jcotrone@fractyl.com, 978.760.5622
Investor Contact
Stephen Jasper Gilmartin Group
stephen@gilmartinir.com, 619.949.3681