PROLOR Biotech has disclosed positive results from a preclinical toxicology study designed to assess the safety and tolerability of the company's long-acting reversible-pegylation technology (RPeg). The study results demonstrated that RPeg was safe and well tolerated at high doses following repeated administration in rats.
The RPeg platform has been used to develop PROLOR's preclinical drug candidate MOD-6030 (oxyntomodulin), a GLP-1/glucagon dual-receptor agonist peptide in development for the dual indications of obesity and Type II diabetes. MOD-6030, which is expected to enter clinical trials next year, is a long-acting version of oxyntomodulin, a naturally-occurring hormone that acts as a natural satiety signal to reduce food intake and increase energy expenditure following food ingestion.
Previous third-party studies in humans showed that the native oxyntomodulin can reduce appetite and food intake, leading to significant weight loss without apparent side effects. However, as a result of its very short half-life, oxyntomodulin has to be administered via three daily injections. PROLOR developed MOD-6030, its longer-acting version, by combining the naturally-occurring hormone with RPeg technology, designed to increase the half-life of therapeutic peptides and small molecules.
RPeg's expected key competitive advantage is its ability to enable development of long-acting drugs that target the brain and that therefore must penetrate the blood-brain barrier (BBB). RPeg technology has been shown in animal models to significantly enhance the half-life and improve the biological activity of a variety of peptides and small molecules, including compounds that need to cross the BBB, such as the appetite suppressant peptide, PYY, and MOD-6030, as well as the diabetes-related compound, exendin-4, the blood pressure-controlling hormone, ANP, and the intravenous antibiotic drug, gentamicin.