NEW YORK – Fractyl Health on Friday said it intends to initiate a first-in-human trial of a gene therapy it's developing to treat type 2 diabetes, RJVA-001, in the first half of 2025.
Burlington, Massachusetts-based Fractyl has completed preclinical in vivo studies that it said will support a clinical trial application for the experimental gene therapy.
RJVA-001 will be the first clinical candidate in Fractyl's Rejuva gene therapy program, in which it's developing adeno-associated virus (AAV) vector-based gene therapies targeting the pancreas as treatments for metabolic diseases. RJVA-001 uses an AAV9 vector to deliver a transgene with a modified insulin promoter and a modified human GLP-1 coding sequence.
Fractyl is prioritizing advancing RJVA-001 and its lead candidate Revita, an investigational drug for weight maintenance in obesity patients who discontinue GLP-1s, while pausing investments into studying Revita for type 2 diabetes. The company is also laying off 17 percent of its workforce. These cost-cutting measures are expected to extend its cash runway into 2026.