Omeros Corporation today announced that it has requested Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the development of OMS824 for the treatment of Huntington's disease. OMS824 selectively inhibits phosphodiesterase 10 (PDE10), an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia. OMS824 has shown promising results in animal models directly relevant to Huntington's disease and, as previously announced, OMS824 was well tolerated and exhibited favorable pharmacokinetic properties in a Phase 1 clinical program. Omeros is currently advancing OMS824 into a Phase 2 program.
FDA's Fast Track program facilitates the development of drugs intended to treat serious or life-threatening conditions and that have the potential to address unmet medical needs. Fast Track drugs are eligible for more frequent and timely meetings with FDA to discuss the development plan and to ensure that data needed for approval are collected appropriately. Drugs in the Fast Track program typically are granted priority review status and their respective New Drug Applications are accepted and reviewed by the FDA as rolling submissions.
"Huntington's disease is devastating, and there is agreement among specialists and affected families that the cognitive and behavioral symptoms of the disease are the primary source of functional impairment," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "There currently are no drugs that improve cognition in Huntington's patients nor are there any disease-modifying therapies. OMS824 holds the potential to improve both cognition and movement and to reduce the rate of neurodegeneration, thereby slowing disease progression. If granted, Fast Track designation will provide the opportunity to streamline clinical development of this promising compound."