PROLOR Biotech, Inc. (NYSE MKT: PBTH) today announced positive results from a preclinical toxicology study designed to assess the safety and tolerability of PROLOR's proprietary long-acting reversible-pegylation technology ("RPeg"). The study results demonstrate that RPeg was safe and well-tolerated at high doses following repeated administration in rats.
The RPeg platform has been utilized to develop PROLOR's preclinical drug candidate MOD-6030, a GLP-1/Glucagon dual receptor agonist peptide in development for the dual indications of obesity and type 2 diabetes. RPeg can also potentially be applied to a range of peptide and small molecule drugs to increase their duration of action, and it is expected to be especially well suited for use with drugs that must cross the blood-brain barrier.
"The positive results of this toxicology study are an important milestone as PROLOR continues the preclinical development of MOD-6030, which is expected to enter clinical trials next year," noted Shai Novik , President of PROLOR. "These results also add to the positive preclinical safety data supporting the use of RPeg as a safe and well-tolerated platform for the development of a broad range of long-acting peptides and small molecule drugs. We intend to apply RPeg to internal projects and also to share these data with potential partners whose drug candidates may benefit from this promising technology."
PROLOR is using its RPeg technology to develop long-acting therapeutic peptides and small molecules. RPeg's expected key competitive advantage is its unique ability to enable development of long-acting drugs that target the brain and that therefore must penetrate the blood-brain barrier. The 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 blood-brain barrier, such as the appetite suppressant peptide PYY and PROLOR's dual action drug candidate MOD-6030, as well as the diabetes-related compound exendin-4, the blood pressure controlling hormone ANP and the intravenous antibiotic drug gentamicin.