Fractyl Health, a metabolic therapeutics company focused on pioneering pattern breaking approaches for the treatment of obesity and type 2 diabetes (T2D), announced it is prioritizing 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. 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.
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“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 channeling 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.”
