Fractyl Health
Fractyl Health is pioneering innovative treatments for type 2 diabetes and obesity, with its lead product, Revita, designed to remodel the duodenal lining and currently available in Germany.
Treatment for Type 2 Diabetes and Obesity
Fractyl Health is at the forefront of developing novel treatments for type 2 diabetes (T2D) and obesity. The company aims to address the root causes of these conditions through its innovative therapies. Fractyl Health's primary focus is on advanced interventions that go beyond traditional methods, emphasizing remodeling and gene therapy. Their mission is to deliver these groundbreaking treatments to patients as broadly and quickly as possible.
Revita: An Innovative Approach
Fractyl Health's lead product candidate, Revita, is designed to remodel the duodenal lining using hydrothermal ablation. This process aims to edit abnormal intestinal nutrient sensing and signaling mechanisms. Revita has received CE mark approval in Europe and reimbursement authorization in Germany through NUB. The therapy is being tested in a pivotal study for controlling glucose in advanced T2D and for maintaining weight loss after GLP-1 drug discontinuation. The Revita system includes the Revita console, a single-use Revita catheter, and a single-use lineset. The procedure has demonstrated a mean total body weight loss of 3.4% by Week 4, maintained to 4% through Week 48 in patients with advanced T2D.
Rejuva Platform: Next-Generation Gene Therapies
Fractyl Health's Rejuva platform focuses on developing next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies for the treatment of T2D and obesity. Currently in preclinical development, Rejuva's lead candidate, RJVA-001, aims to address issues related to treatment discontinuation and metabolic rebound typically seen with existing GLP-1-based therapies. Fractyl Health is working with European regulators to align on an IND-enabling path for RJVA-001, which has been nominated as the first clinical T2D candidate under the Rejuva platform.
Regulatory Milestones and Future Plans
Fractyl Health is committed to advancing its therapies through regulatory pathways. The company has engaged with European regulators to navigate the IND-enabling process for RJVA-001. Furthermore, it plans to submit an Investigational Device Exemption for a potentially pivotal clinical study to regulatory authorities in the first half of 2024. This study will focus on the use of Revita for weight maintenance after the discontinuation of GLP-1-based drugs. Revita is now available in Germany, enhancing access to this innovative treatment.
Clinical Impact of Revita
The Revita procedure by Fractyl Health has shown promising results in clinical studies. Patients with advanced T2D experienced a mean total body weight loss of 3.4% by Week 4, with this effect maintained at 4% mean total body weight loss through Week 48. Moreover, Revita has potential in preventing weight regain after initial weight loss achieved through other methods, making it a significant advancement in the management and treatment of obesity and type 2 diabetes.