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Fractyl Health, Inc. (Nasdaq: GUTS) is a pioneering metabolic therapeutics company based in Burlington, MA, dedicated to transforming the treatment of metabolic diseases such as type 2 diabetes (T2D) and obesity. The company aims to shift the paradigm from chronic symptomatic management to durable disease-modifying therapies that address the root causes of these conditions at the organ level.
Fractyl Health's leading product candidate, Revita®, focuses on remodeling the duodenal lining through hydrothermal ablation, known as duodenal mucosal resurfacing (DMR). This innovative approach aims to correct abnormal intestinal nutrient sensing and signaling mechanisms, which are potential root causes of metabolic diseases like T2D and obesity. Revita has received a CE mark in Europe and reimbursement authorization in Germany for T2D treatment. In the United States, Revita is for investigational use only. The company is currently enrolling patients in pivotal studies such as Revitalize-1 and Remain-1 to further investigate the efficacy of Revita.
Additionally, Fractyl Health's Rejuva® platform is in the preclinical development stage, focusing on next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies. The platform aims to offer novel, disease-modifying therapies that target the pancreas, leveraging advanced delivery systems and proprietary screening methods.
Recently, Fractyl Health presented new preclinical data from its Rejuva platform at the Digestive Disease Week (DDW) 2024, showcasing the potential of GLP-1 based pancreatic gene therapy to reduce liver fat in diet-induced obesity models. The company also shared impressive 6-month follow-up data from its German real-world registry study of Revita for T2D, highlighting significant improvements in blood sugar levels, body weight, and medication burden among participants.
Fractyl Health continues to advance its mission with promising research and active participation in major medical conferences. The company’s strategic goals include progressing towards regulatory approvals and expanding clinical studies to validate their innovative therapies.
For more information, visit www.fractyl.com or follow Fractyl Health on Twitter.
Fractyl Health (GUTS) reported Q2 2024 financial results and provided business updates. Key highlights include:
1. Updated clinical results from German Real-World Registry showing Revita®'s potential for sustained weight loss and blood sugar reduction for at least one year post-treatment.
2. FDA Breakthrough Device designation for Revita in weight maintenance after GLP-1 drug discontinuation.
3. Initiation of REMAIN-1 pivotal study for Revita in weight maintenance, with data readouts expected from Q4 2024.
4. REVITALIZE-1 study on track to report topline data in mid-2025 for an expanded Type 2 Diabetes patient population.
5. Presentation of preclinical data comparing Rejuva® to semaglutide at ADA 2024 Conference.
6. Q2 2024 financial results: R&D expenses $16.8M, SG&A expenses $6.2M, net loss $17.2M, cash position $102.4M.
Fractyl Health (Nasdaq: GUTS) announced promising clinical results from its German Real-World Registry for the Revita® endoscopic procedure. After 12 months, patients experienced:
- A median weight decrease from 111 kg to 97 kg (13% total body weight loss)
- A median HbA1c reduction from 9.6% to 7.2%
- Stable or decreased glucose-lowering medications in 10 out of 11 patients
The study involved 11 hard-to-treat patients with obesity and Type 2 Diabetes. Revita, designed to resurface the duodenal lining, shows potential as a durable weight maintenance solution. The procedure was well-tolerated with no reported adverse safety events.
Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focusing on innovative treatments for obesity and type 2 diabetes, has announced it will release its second quarter 2024 financial results and provide business updates on August 14, 2024, at 4:30 p.m. ET. The company will host a live webcast of the conference call, which can be accessed through the 'Events' section of Fractyl's investor relations website. For those unable to attend the live event, an archived version of the webcast will be made available for replay on the company's website.
Fractyl Health (Nasdaq: GUTS) has received FDA Breakthrough Device Designation for its Revita System in weight maintenance for people with obesity who discontinue GLP-1 drugs. Revita is an outpatient endoscopic procedure targeting the duodenal lining to potentially treat root causes of obesity and type 2 diabetes. The designation will enable priority FDA review upon completion of the REMAIN-1 study, with data readouts expected from Q4 2024.
Key points:
- Revita aims to address high discontinuation rates and substantial weight regain after stopping GLP-1 drugs
- Breakthrough status may accelerate development, assessment, and review processes
- Previous studies suggest potential for durable weight maintenance after a single Revita procedure
- Revita is already approved in Germany for T2D treatment
Fractyl Health will participate in the Piper Sandler 2nd Annual Virtual Obesity Day on June 26, 2024, at 9:30 a.m. EDT. CEO Dr. Harith Rajagopalan and CSO Dr. Timothy Kieffer will discuss recent corporate updates. Key highlights include the acceleration of their weight maintenance clinical study and compelling preclinical data from their Rejuva® pancreatic gene therapy. This data, presented at the American Diabetes Association’s 84th Scientific Session, demonstrated greater and more durable weight loss compared to semaglutide. Rejuva’s data was recognized as the top abstract out of 8,000 submissions. For more details and access to the webcast, please contact your Piper Sandler representative.
Fractyl Health (Nasdaq: GUTS) announced the acceleration of its REMAIN-1 clinical study, focusing on Revita's effectiveness in maintaining weight loss post-GLP-1 therapy discontinuation. Open label data from the REVEAL-1 cohort is expected in Q4 2024, with mid-point analysis by Q2 2025. The FDA approved an amendment expanding the Revita study (REVITALIZE-1) to include patients inadequately controlled on any glucose-lowering agent, significantly increasing the eligible U.S. treatment population. Additionally, Fractyl presented preclinical data at the ADA's 84th Scientific Sessions, showing greater and more durable weight loss with Rejuva® therapy compared to semaglutide. The company aims to address the high weight regain rates post-GLP-1 therapy and enhance glucose regulation for T2D patients.
Fractyl Health presented new preclinical data on its Rejuva® GLP-1 pancreatic gene therapy at the ADA's 84th Scientific Sessions. The studies showed that a single administration of Rejuva reduced fat mass by 21%, improved glycemia, and retained lean mass in a diet-induced obesity (DIO) mouse model. Post-semglutide withdrawal, Rejuva maintained a 17% reduction in fat and 22% weight loss. These findings suggest Rejuva can mimic natural GLP-1 release and sustain weight and glycemic improvements, addressing a critical need for a long-lasting obesity and T2D treatment.
Fractyl Health (Nasdaq: GUTS) will present new preclinical obesity data from its Rejuva® platform at the American Diabetes Association's (ADA) 84th Scientific Sessions in Orlando, FL, on June 23, 2024. The study, titled "Single-Dose GLP-1-Based Pancreatic Gene Therapy Durably Maintains Body Composition and Glycemia after Semaglutide Withdrawal in a Murine Model of Obesity," has been selected as one of eight Presidents' Select abstracts. CEO Dr. Harith Rajagopalan will present the findings. Additionally, Fractyl will host an in-person Key Opinion Leader (KOL) event on June 24, 2024, featuring Dr. David A. D’Alessio from Duke University School of Medicine. The event will be webcast live for those unable to attend.
Fractyl Health presented preclinical data on its Rejuva GLP-1 pancreatic gene therapy at Digestive Disease Week 2024. The therapy showed significant reductions in liver weight (42%), liver triglycerides (67%), total cholesterol (36%), and LDL cholesterol (51%) compared to placebo two months post-administration. These results highlight the potential for profound metabolic benefits from a single administration. The company plans to nominate its first GLP-1 PGTx candidate for obesity in H2 2024. The therapy aims to address metabolic dysfunction-associated liver diseases such as MASLD and MASH, which are major causes of liver transplants in the U.S. Rejuva utilizes a proprietary delivery method to target the pancreas, aiming for durable effects on glucose and weight control.
Fractyl Health (Nasdaq: GUTS) announced its Q1 2024 financial results, highlighting several key developments and milestones. The company reported revenues from its pilot commercial launch in Germany but faced increased R&D and SG&A expenses, leading to a net loss of $3.3 million. However, this was a significant improvement from the $11.9 million loss in Q1 2023, primarily due to a $17.1 million non-cash gain.
Fractyl expects to initiate the Remain-1 pivotal study for weight maintenance in H2 2024 and anticipates topline data from the Revitalize-1 study in Q4 2024. The company is also progressing with its Rejuva gene therapy program, aiming to present new preclinical data in May 2024 and complete IND-enabling studies by H2 2024. Additionally, Fractyl appointed Adrian Kimber as Chief Commercial Officer to lead launch readiness for Revita.
Fractyl’s cash position as of March 31, 2024, was $121.4 million, which is expected to fund operations through 2025. The company will discuss these updates in a conference call on May 13, 2024.
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