Fractyl Health, developing procedural and gene therapies for type 2 diabetes and obesity, filed an S-1 filing with the SEC on Thursday to raise up to $100 million in an initial public offering.
Fractyl Health is a metabolic therapeutics company focused on new approaches for metabolic diseases, including type 2 diabetes and obesity.
Its lead candidate, the Revita DMR System, is an outpatient procedural therapy designed to modify duodenal dysfunction.
Revita is approved for patients with inadequately controlled type 2 diabetes in Europe.
The company is enrolling a pivotal study of Revita in patients with inadequately controlled type 2 diabetes, with topline data expected in 4Q24. It plans to evaluate Revita in a clinical study for weight maintenance, expecting to submit an IDE and comparable documents to the FDA in the first half of 2024.
Fractyl is also developing Rejuva, an adeno-associated virus-delivered pancreatic gene therapy platform, and it plans to nominate its first candidate in the 1Q24.
The company was founded in 2010 and plans to list on the Nasdaq under the symbol GUTS.
As the gold rush in obesity meds shows no sign of slowing, Fractyl Health's filing comes on the heels of diabetes and obesity-focused biotech Carmot Therapeutics, which announced earlier this month that it would be acquired by Roche Holdings AG RHHBY, shortly after filing for an IPO in late November.
In October, Fractyl Health presented data showing that a single dose of Rejuva could reduce body fat by 24.8% in a mouse model of type 2 diabetes, compared to 18.4% in animals given daily doses of Novo Nordisk A/S NVO semaglutide available as Wegvoy and Ozempic.
The company is currently working on lead optimization and IND-enabling toxicology studies and is targeting 2024 for its first human studies.
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