Fractyl Health Eyes Q4 Revita Data, Launches Rejuva Gene Therapy Trial
GUTS
Fractyl HealthGUTSis advancing two one-time treatment approaches intended to provide durable benefits for obesity, type 2 diabetes and related metabolic diseases, Chief Executive Officer Harith Rajagopalan said during a Canaccord discussion
The company’s lead program, Revita, uses an outpatient endoscopic procedure to ablate a section of the duodenum, the first part of the small intestine. Rajagopalan said the approach is designed to address duodenal dysfunction, which the company views as a root contributor to abnormal nutrient sensing, body weight and glucose regulation in metabolic disease
Fractyl’s second program, Rejuva, is a pancreatic gene therapy platform. Its lead candidate, RJVA-001, has received clearance to begin a first-in-human study, with site activation expected imminently and initial patient enrollment and dosing anticipated later this year, Rajagopalan said
Revita Pivotal Data Expected in Early Fourth Quarter
Revita was initially developed for type 2 diabetes, where Fractyl generated sham-controlled data in hundreds of patients The company later shifted emphasis toward post-GLP-1 weight maintenance after observing that patients receiving a single Revita procedure showed initial weight loss followed by sustained weight maintenance over one and two years without reported changes to diet or lifestyle
Rajagopalan said Fractyl now has one-year results from two post-GLP-1 weight-maintenance studies: the open-label REVEAL-1 trial and a randomized, double-blind, sham-controlled pilot study known as the Midpoint Cohort
In those pilot studies, patients who had lost 40 to 50 pounds while taking tirzepatide maintained more than 80% of that weight loss at one year, Rajagopalan said. By comparison, he said the sham group and historical controls had regained about 60% of lost weight by one year
The company expects results in early fourth quarter from a 300-patient pivotal trial evaluating Revita following GLP-1-assisted weight loss. The study enrolls patients with obesity but without prior GLP-1 treatment or type 2 diabetes, gives them tirzepatide until they reach at least 15% total body weight loss, and then randomizes eligible participants two-to-one between Revita and a sham procedure
The study’s first co-primary endpoint compares Revita and sham at six months. Rajagopalan said Fractyl expects the sham arm to regain roughly 10% of body weight, while the Revita group is expected to regain less than half that amount. A second co-primary endpoint evaluates durability at 12 months in the Revita arm, with the FDA requiring that at least 50% of patients maintain at least 5% total body weight loss relative to their pre-GLP-1 baseline
Fractyl expects 12-month data in the first quarter. Rajagopalan said the company intends to compile the six-month efficacy results and safety package for a filing by year-end, followed by an update to the FDA once 12-month data are available
Commercial Strategy Focuses on Procedure Centers
Rather than adopting a pharmaceutical-style distribution model, Fractyl plans a center-by-center commercial rollout if Revita is approved. Rajagopalan said the company has conducted clinical-trial work at nearly 50 U.S. centers, including major health systems such as UCLA Health, Northwell Health and West Virginia University Health System
The company expects to target gastroenterologists performing the procedure as well as bariatric surgeons with established referral networks. Rajagopalan said most U.S. endoscopies are performed in the top 200 to 400 academic and private health systems, potentially allowing for a focused commercial sales force
Fractyl also has a letter of intent with Bariendo, now called Everself, a provider of bariatric and metabolic endoscopy services. Rajagopalan said Everself had 15 centers when the agreement was signed and has since doubled that number. He said the relationship could provide access to an additional private-center distribution network following approval
The initial patient-identification opportunity may include people taking GLP-1 therapies who are already scheduled for endoscopies, as well as patients visiting gastrointestinal clinics because of GLP-1-related side effects. Rajagopalan said there are more than 100 million Americans with obesity and 30 million Americans taking GLP-1 therapies for obesity, with approximately 1 million discontinuing such treatment each month
Rejuva’s RJVA-001 is designed to deliver a gene therapy locally to the pancreas, enabling beta cells to produce human GLP-1. Rajagopalan said the candidate uses an AAV9 viral vector and an insulin promoter intended to produce low circulating GLP-1 levels that more closely mimic normal physiology
In preclinical models, he said RJVA-001 generated low GLP-1 levels that Fractyl believes could potentially reduce the nausea and vomiting associated with higher-dose GLP-1 pharmacology, while delivering efficacy that the company said exceeded existing GLP-1 treatments in those models
Rajagopalan said Fractyl plans to discuss its commercial model and rollout strategy further at an investor day scheduled for Sept. 1
About Fractyl HealthGUTS
Fractyl Health, Inc is a clinical-stage medical technology company focused on the development and commercialization of minimally invasive, endoscopic therapies for metabolic diseases. Headquartered in Lexington, Massachusetts, Fractyl is advancing treatments that target the underlying physiology of conditions such as type 2 diabetes, obesity and nonalcoholic fatty liver disease (NAFLD) by modifying the duodenal mucosa to improve metabolic control
The company’s lead product, Revita® Duodenal Mucosal Resurfacing (Revita DMR), employs a catheter-based hydrothermal ablation technique to remodel the lining of the upper small intestine
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com
Where Should You Invest $1,000 Right Now?
Before you make your next trade, you’ll want to hear this
MarketBeat keeps track of Wall Street’s top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis
Our team has identified thefive stocksthat top analysts are quietly whispering to their clients to buy now before the broader market catches on… and none of the big name stocks were on the list
They believe these five stocks are the five best companies for investors to buy now
MarketBeat
Read more from MarketBeat
