Company hopes to raise up to $100 million after Rejuva gene therapy outperforms semaglutide in rodent obesity studies.
Metabolic therapeutics company Fractyl Health has filed its intention to go public with the US Securities and Exchange Commission. The company targets metabolic diseases such as type 2 diabetes (T2D) and obesity, and hopes to raise up to $100 million in an initial public offering, which would see the company listed on the Nasdaq under the symbol GUTS.
Fractyl is developing therapies designed to address the root causes of T2D and obesity at the organ level, allowing for long-term maintenance of metabolic health without the burden of lifelong pharmacotherapy. The company’s Rejuva platform is a locally administered, AAV-based pancreatic gene therapy, designed to enable long-term remission of T2D and obesity by altering metabolic hormone function in pancreatic islet cells.
Fractyl recently presented preclinical efficacy results in a rodent model of obesity, where its GLP-1 gene therapy outperformed semaglutide (the active agent in Wegovy and Ozempic) in a head-to-head weight loss study. The company says it plans to nominate its first GLP-1 gene therapy candidate for T2D in the first quarter of 2024, with an expected Investigational New Drug application submission in the second half of the same year.
Fractyl is also developing the Revita DMR System, an outpatient procedural therapy designed to modify duodenal dysfunction—a consequence of high-fat and high-sugar diets that can trigger T2D and obesity. The company has obtained FDA Breakthrough Device designation for Revita and is currently enrolling patients in its pivotal Revitalize-1 study. Anticipated to complete enrollment in the second quarter of 2024, the study aims to report topline data by the end of next year.
Revita is already approved for inadequately controlled T2D patients in Europe, and the company’s pilot commercial launch in Germany was initiated earlier this year.
“We believe our product candidates are not only unique in their potential for disease modification, but also in their design for broad accessibility for large populations,” said the company in its filing. “Accordingly, we believe our candidates have the capacity to revolutionize treatment of T2D and obesity and, at their fullest potential, significantly reduce the burden of metabolic disease globally.”