Fractyl Health Inc（GUTS）のニュースとイベントGUTSFractyl Health Inc

Fractyl Health Reports Six-Month Results from REMAIN-1 Study

Fractyl Health announced topline six-month results from the Pivotal Cohort of its ongoing REMAIN-1 study, a 308-participant, multicenter, randomized, double-blind, sham-controlled study of the Revita DMR System for weight maintenance in adults with obesity following discontinuation of GLP-1 therapy. REMAIN-1 met its pre-specified six-month co-primary endpoint of weight loss retention, as patients treated with a single Revita procedure demonstrated a highly statistically significant reduction in weight regain compared to sham. The second prespecified co-primary endpoint, the percentage of participants who maintain 5% or greater total body weight loss, will be assessed at 12 months. The company believes these 6-month results reinforce the potential of Revita to be the first durable procedural therapy for post-GLP-1 weight maintenance and support the company's planned De Novo marketing application submission in late Q4. In the modified intention-to-treat, or mITT, population, Revita participants maintained approximately 80% of their GLP-1-induced weight loss after a single treatment at six months, compared with 67% in sham participants, with high statistical significance. 32% of Revita participants were either weight stable or had further weight loss at 6-months post GLP-1 discontinuation, versus 18% for sham. In a post hoc analysis by ablation length, participants who received 12 to 18 cm of duodenal ablation had 43% less regain than sham. Participants who received 20 cm or more had 53% less regain than sham. This is consistent with results from the REMAIN-1 Midpoint Cohort that indicated more complete duodenal ablation drove greater treatment effect. The difference in weight regain between Revita and sham widened at each assessment, nearly doubling from Month 3 to Month 6. There have been no device- or procedure-related serious adverse events, no deaths, and no unanticipated adverse device effects observed as of the September 24, data cut-off date. Related adverse events were predominantly mild and peri-procedural, with 94% occurring within seven days of the procedure and the vast majority within two days. Consistent with upper GI endoscopy, the company believes these generally mild peri-procedural adverse events support potentially broad outpatient use for Revita, if approved. With topline six-month data now reported from the REMAIN-1 Pivotal Cohort, Fractyl is advancing toward its remaining anticipated 2026 milestone, a potential DeNovo regulatory submission, and preparing for a potential U.S. commercial launch.

Fractyl CEO: Revita Procedure Significantly Reduces Weight Regain

"With one-year randomized data for the REMAIN-1 Midpoint Cohort and open label data for REVEAL-1 Cohort, we have the clearest evidence yet that a single Revita procedure can meaningfully reduce weight regain after GLP-1 discontinuation, with the greatest benefit observed in patients who received an adequate dose of duodenal ablation," said Harith Rajagopalan, Co-Founder and Chief Executive Officer of Fractyl. "Together with a favorable one-year safety profile and cash runway into early 2027, these results give us continued confidence in the design and execution of our ongoing REMAIN-1 Pivotal Cohort, with topline six-month data on track for early Q4 2026 and a potential FDA De Novo submission to follow later in the quarter. As we approach these anticipated milestones, we are also building the commercial infrastructure needed to bring Revita to the patients with the greatest need."