Weight-Loss Drug Gold Rush Gets Larger As New Player Fractyl Health Files For $100M IPO
Weight-Loss Drug Gold Rush Gets Larger As New Player Fractyl Health Files For $100M IPO
Revita is approved for patients with inadequately controlled type 2 diabetes in Europe. 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.
爲2型糖尿病和肥胖症開發程序和基因療法的Fractyl Health週四向美國證券交易委員會提交了S-1文件，要求在首次公開募股中籌集高達1億美元的資金。
Fractyl Health is a metabolic therapeutics company focused on new approaches for metabolic diseases, including type 2 diabetes and obesity.
Fractyl Health 是一家代謝療法公司，專注於新陳代謝疾病的治療方法，包括 2 型糖尿病和肥胖。
Its lead candidate, the Revita DMR System, is an outpatient procedural therapy designed to modify duodenal dysfunction.
其主要候選藥物Revita DMR System是一種旨在改善十二指腸功能障礙的門診手術療法。
Revita is approved for patients with inadequately controlled type 2 diabetes in Europe.
Revita 獲准用於歐洲控制不充分的 2 型糖尿病患者。
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.
該公司正在註冊一項針對2型糖尿病控制不當的患者的Revita的關鍵研究，預計將在24年第四季度公佈初步數據。它計劃在一項維持體重的臨床研究中對Revita進行評估，預計將在2024年上半年向美國食品藥品管理局提交一份IDE和類似文件。
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.
Fractyl還在開發Rejuva，這是一種腺相關病毒輸送胰腺基因治療平台，並計劃在第一季度提名其首個候選藥物。
The company was founded in 2010 and plans to list on the Nasdaq under the symbol GUTS.
該公司成立於2010年，計劃在納斯達克上市，股票代碼爲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 (OTC: RHHBY), shortly after filing for an IPO in late November.
由於肥胖藥物的淘金熱沒有放緩的跡象，Fractyl Health的申請是在糖尿病和肥胖症爲重點的生物技術公司Carmot Therapeutics之後提交的。該公司在11月下旬申請首次公開募股後不久宣佈將被羅氏控股公司（場外交易代碼：RHHBY）收購。
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 (NYSE: NVO) semaglutide available as Wegvoy and Ozempic.
10月，Fractyl Health公佈的數據顯示，在2型糖尿病小鼠模型中，單劑量Rejuva可以減少體內脂肪24.8％，而每天服用Novo Nordisk A/S（紐約證券交易所代碼：NVO）semaglutide（紐約證券交易所代碼：NVO）的動物體內脂肪減少18.4％。
The company is currently working on lead optimization and IND-enabling toxicology studies and is targeting 2024 for its first human studies.
該公司目前正在進行先導藥物優化和支持IND的毒理學研究，並計劃在2024年進行首批人體研究。
譯文內容由第三人軟體翻譯。