Fractyl Health prioritizes REMAIN-1 study, extends cash runway to 2026.

Fractyl Health is prioritizing its REMAIN-1 pivotal study to address patient and physician demand for an off-ramp to GLP-1 drugs. The study is expected to have midpoint data analysis in Q2 2025 and full enrollment in summer 2025. Additionally, the company's RJVA-001 gene therapy candidate is on-track for first-in-human studies in H1 2025. This decision is expected to extend the company's cash runway into 2026.

Fractyl Health, a pioneering metabolic therapeutics company, is prioritizing its REMAIN-1 pivotal study to address the growing demand for an alternative to GLP-1 drugs for weight management [1]. With midpoint data analysis anticipated in the second quarter of 2025 and full enrollment expected in the summer, the study aims to provide a scalable solution for maintaining clinically significant weight loss in the absence of ongoing medical therapy.

According to the company's announcement, initial clinical results from the REVEAL-1 open-label cohort of the REMAIN-1 study have shown promising trends one month after GLP-1 drug discontinuation and Revita procedure [1]. These findings align with observations in prior Revita clinical studies and the German Real-World Registry, indicating that discontinuation of GLP-1 drugs can result in rapid weight and metabolic rebound, jeopardizing the benefits achieved with the drugs [1].

The need for innovative solutions in weight management is becoming increasingly urgent, as the demand for alternatives to GLP-1 therapy continues to grow among patients and healthcare professionals [1]. The high demand to participate in the REMAIN-1 study underscores this need and provides hope for a scalable solution to maintain weight loss even without ongoing medical therapy.

Fractyl Health's RJVA-001 gene therapy candidate is also on-track for first-in-human studies in the first half of 2025, which is expected to extend the company's cash runway into 2026 [1]. This decision further solidifies Fractyl Health's commitment to addressing the most pressing challenges in obesity and metabolic disease.

References:

[1] Fractyl Health, Inc. (2025, January 13). Fractyl Health Announces Positive Initial Clinical Results and Strong Enrollment Progress for REMAIN-1 Weight Maintenance Pivotal Study. GlobeNewswire. https://www.globenewswire.com/news-release/2025/01/13/2584691/0/en/Fractyl-Health-Announces-Positive-Initial-Clinical-Results-and-Strong-Enrollment-Progress-for-REMAIN-1-Weight-Maintenance-Pivotal-Study.html