Fractyl Health, Inc. (GUTS) announced positive six-month randomized results from its REMAIN-1 Midpoint Cohort, a blinded, sham-controlled study evaluating Revita for weight maintenance following GLP-1 drug discontinuation.
Revita is Fractyl Health's lead product candidate, designed to remodel the duodenal lining via a minimally invasive endoscopic procedure to restore healthy nutrient sensing and signaling disrupted by chronic metabolic diseases.
Patients treated with Revita experienced sustained weight maintenance, improved cardiometabolic profiles, and reduced food cravings compared with sham at six months, with continued excellent safety and tolerability. Among patients with above median GLP-1-associated weight loss, Revita treatment resulted in approximately 70% less post-GLP-1 weight regain versus sham.
The REMAIN-1 Midpoint Cohort included 40 patients, with five excluded per protocol due to diet and lifestyle noncompliance. Revita-treated patients showed a 4.5% weight regain compared to 7.5% in the sham arm at six months. In exploratory analysis, patients with above median GLP-1 associated weight loss experienced only 4.2% weight regain with Revita versus 13.3% with sham, corresponding to a 70% relative reduction.
Supportive exploratory endpoints demonstrated improvements in cardiometabolic lipid parameters, including increased HDL cholesterol and reduced triglyceride-to-HDL ratio, as well as meaningful reductions in sweet-food cravings compared with sham.
Safety results remained favorable, with no treatment-emergent serious adverse events related to the device or procedure and no study discontinuations due to adverse events.
Based on ongoing interactions with the U.S. FDA and encouraging safety data, Fractyl has requested FDA feedback on potentially reclassifying Revita under the De Novo pathway, with feedback expected in the second quarter of 2026. Topline six-month pivotal data and a potential FDA filing are anticipated in the second half of 2026.
Revita has received FDA Breakthrough Device designation for weight maintenance in people with obesity who discontinue GLP-1 therapies. It remains investigational in the United States and is CE marked in the European Union and United Kingdom.
The company ended September 30, 2025, with cash and cash equivalents of $77.7 million, which it expects will fund operations into early 2027.
GUTS has traded between $0.82 and $3.03 over the past year. The stock closed yesterday's trading at $1.83, down 13.68% and fell further in the pre-market to $0.58, down 68.31%.
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