Until recently, there has been little insight into the root cause of metabolic disease and, as a result, advancements to address the resulting conditions have been incremental at best – addressing only symptoms, with little impact on patient outcomes. At Fractyl, we are applying new scientific insights in intestinal biology to advance treatments and potential cures for metabolic diseases.
Our product pipeline leverages our proprietary procedural therapy, which is designed to rejuvenate the lining of the duodenum to improve patient health, and initially targets patients with metabolic conditions resulting from insulin resistance, including type 2 diabetes (T2D), nonalcoholic steatohepatitis (NASH), and polycystic ovarian syndrome (PCOS).
The intestinal lining (duodenal mucosa) is our body’s largest hormone-producing (“endocrine”) organ, the largest nervous system outside of the brain, an important line of defense against infection, and host to a complex microbiome.
Our research has demonstrated that insulin resistance is caused by an overgrowth (hyperplasia) of the duodenal lining that results from years of diets high in fats and sugar. This hyperplasia leads to changes in the amount of key hormones produced and key nutrients absorbed in this section of the gut. These changes affect both insulin production by the pancreas and the body’s responsiveness to that insulin. Because of these hormonal signals, when the mucosa becomes hyperplastic, patients become predisposed to insulin resistance and metabolic disease.
To treat and hopefully reverse metabolic diseases, we have developed Revita™ DMR (duodenal mucosal resurfacing), a minimally invasive, outpatient procedural therapy designed to rejuvenate the lining of the duodenum.
We have received a CE Mark to commercialize Revita DMR in Europe based on our clinical work, and global, follow-on clinical trials are advancing in T2D, NASH and PCOS. In addition, we are exploring the use of our Revita DMR technology coupled with cell and gene therapy to fully restore patient health.
Our scientific insights in intestinal biology have led to discovery efforts beyond Revita DMR, including products in the pipeline targeting weight loss and intestinal cell + gene therapy. Contact Fractyl for more information about our pipeline.
The intestinal lining (duodenal mucosa) is our body’s largest hormone-producing (“endocrine”) organ, the largest nervous system outside of the brain, an important line of defense against infection, and host to a complex microbiome.
A metabolic disease characterized by hormonal changes leading to insulin resistance, poor pancreatic function, and elevated blood sugar levels (hyperglycemia)
T2D affects 400 million people worldwide, 30 million in the US
More than 50% of patients have poor blood sugar control
Annual cost estimated at $245 billion in the US from disease
No current treatment for underlying cause
A severe type of nonalcoholic fatty liver disease (NAFLD), NASH occurs when a buildup of fat in the liver leads to inflammation and damage
In the US, an estimated 80 million people are living with NAFLD, and about 30 million of them have progressed to NASH, but both conditions are believe to be underdiagnosed
More than 50% of NASH patients also have type 2 diabetes; these patients represent the highest cost to the healthcare system, are at the highest risk of diabetic complications, and have a ten times higher risk of liver/pancreatic cancer
No current treatments
Increasingly recognized as a metabolic disease, PCOS is a variable disorder marked by amenorrhea, hirsutism, obesity, infertility, and ovarian enlargement
A leading cause of female infertility due to insulin resistance and other hormonal dysfunction
Estimated to affect 5-7% of women worldwide with the highest rates of occurrence in the Middle East
No current treatment for underlying cause