During a presentation at the annual meeting of the European Association for the Study of Diabetes (EASD), Fractyl Health unveiled compelling findings regarding its GLP-1-based pancreatic gene therapy, commercially known as Rejuva. The data showcased a remarkable performance in weight loss, particularly when compared to semaglutide injections, at least in the context of experiments conducted with mice.
The presentation highlighted that a solitary administration of Rejuva resulted in a substantial reduction of approximately 25% in body fat within a mouse model replicating type 2 diabetes. In contrast, mice subjected to daily doses of semaglutide exhibited a comparatively less substantial reduction, with body fat decreasing by approximately 18%.
Novo Nordisk markets semaglutide under the brand names Ozempic and Wegovy for diabetes and obesity respectively. Companies are racing to develop better versions of the medicine as demand rises in the obesity sector. When compared to industry heavyweights like Pfizer and Eli Lilly, whose diabetic drug Mounjaro recently won FDA approval, Fractyl still falls short. Meanwhile, Novo has been filling its pipeline with cutting-edge options.
Fractyl Chief Scientific Officer Timothy Kieffer remarked, “ Rejuva has the potential to offer these benefits because it targets the pancreas, is designed to mimic human physiology, and may provide durable benefits that persist after the treatment itself.”
At the conclusion of the experiment, which lasted for eight weeks, not only had all of the mice lost weight, but their fasting insulin and blood glucose concentrations had also improved. During the first 15 days of the research, they kept dropping pounds.
In order for Rejuva to operate, an inactive form of the adeno-associated virus is used to transmit a gene that increases the expression of GLP-1 in pancreatic cells. This leads to insulin to be released. In contrast to semaglutide, which is administered subcutaneously, Rejuva is intended for intravenous administration to the pancreas. However, intraperitoneal injections were used in the most recent study. According to Fractyl, the structure of the gene therapy, along with the method of delivery, confines it to the pancreas, thereby lowering the likelihood of having off-target consequences.
Fractyl’s CEO and co-founder, Harith Rajagopalan, M.D., Ph.D., who laid out the company’s findings at the EASD conference, claimed that researchers haven’t noticed any signs of tolerability difficulties thus far, though the mouse isn’t a suitable model for tolerance. Studies conducted on tissue samples found no evidence of major adverse health complications, such as pancreatic cancer.
The findings of a proof-of-concept study conducted in pigs, which were presented previously this year at the American Society of Gene & Cell Therapy congress, served as the foundation for this research. Fractyl is now focusing on lead optimization and IND-enabling toxicological tests, and the company plans to conduct its first human studies in 2024.