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Fractyl Health provides update on clinical studies priorities

owenhaskins

Fractyl Health is prioritising its REMAIN-1 pivotal study, addressing the demand for an off-ramp to GLP-1 drugs, while advancing its novel Rejuva gene therapy platform into first-in-human studies. This decision is driven by positive initial feedback from the REVEAL-1 cohort, significant demand for participation in the REMAIN-1 study and strong patient and physician feedback on the urgent need for durable weight maintenance solutions.


Harith Rajagopalan
Harith Rajagopalan

Fractyl will pause investment in its Revita programs for T2D, which consist of the REVITALIZE-1 study and the German Real-World Registry. These measures are expected to extend the company’s cash runway into 2026, through multiple key clinical milestones.


“The real challenge in obesity is no longer losing weight, it is keeping the weight off. The strong response from patients and physicians to the REMAIN-1 study highlights the urgent need for durable weight maintenance solutions, and we are doubling down on our efforts in this space,” said Harith Rajagopalan, Co-Founder and CEO of Fractyl Health. “Revita is the first therapeutic candidate to receive Breakthrough Device designation for weight maintenance, and we are uniquely positioned to address this critical gap. By prioritizing REMAIN-1 and advancing our groundbreaking Rejuva gene therapy platform, we are channelling our resources toward what we believe are the most impactful and differentiated opportunities. Given the rapidly evolving obesity landscape, we are pausing investment in our Revita programs for T2D and sharpening our focus. We believe these strategic steps will enable us to execute on our mission of delivering truly transformative solutions for patients with obesity and metabolic disease.”


Earlier this month, Fractyl reported positive preliminary results from the REVEAL-1 open-label cohort of the REMAIN-1 study. Initial findings from the first patient showed successful weight maintenance following GLP-1 drug discontinuation and Revita procedure. Additional data from the REVEAL-1 cohort is anticipated to be presented in Q1 2025.


The company also announced significant progress in its ongoing REMAIN-1 pivotal study, which is evaluating weight maintenance after discontinuation of GLP-1 drugs. Recruitment for the REMAIN-1 study has generated significant interest, with over 145 patients enrolled across ten clinical study sites in five months since first site activation, reflecting strong engagement from both patients and physicians. This momentum underscores the urgent need for effective post-GLP-1 weight maintenance solutions.


The company has completed enrolment of a sufficient number of patients for the midpoint analysis of the study, which is on track and expected in Q2 2025. Full enrolment in the study is expected in the summer of 2025.


After garnering significant scientific recognition over the past 12 months, Fractyl has completed key preclinical in vivo studies to support a Clinical Trial Application for RJVA-001. The Company is on track to initiate first-in-human studies for RJVA-001 in 2025.

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