BioTuesdays

Fractyl reveals promising preclinical data for pancreatic gene therapy program

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Fractyl Health (NASDAQ:GUTS) has announced that it will present new data from its RJVA-001 Rejuva Smart GLP-1 pancreatic gene therapy program for the treatment of obesity and type 2 diabetes (T2D) at the 22nd World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC).

Rejuva is the Fractyl’s adeno-associated virus (AAV)-based pancreatic gene therapy program, designed to enable durable production of therapeutic proteins by the pancreas to treat obesity and T2D.

“RJVA-001 has the potential to be a game changer in the field of obesity and T2D,” said Harith Rajagopalan, M.D., Ph.D., co-founder and CEO of Fractyl. “We have previously shown in mice models that a single dose of Rejuva can help maintain improvements in both weight and blood glucose levels after withdrawing semaglutide – which is a critical unmet need in the management of obesity and T2D.”

“These data presented at WCIRDC help to establish safety and feasibility of targeted delivery in a large animal model – which is one of the last pieces of data we need to have confidence in the successful delivery to the pancreas in humans, as well as to understand the correct dose for our first-in-human studies with our Smart GLP-1 gene therapy, which will be initiated in the first half of 2025. We look forward to reporting additional data from Rejuva Clinical Trial Application (CTA)-enabling studies at upcoming scientific meetings,” Dr. Rajagopalan concluded.