Omeros Files Investigational New Drug Application for Lead Compound in PDE10 Program
-- Data from First Phase 1 Clinical Trial Expected in 2012 --
SEATTLE, Sept. 6, 2012 /PRNewswire/ -- Omeros Corporation (OMER) today announced that it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) to initiate clinical trials evaluating OMS824, the Company's lead compound from its phosphodiesterase 10 (PDE10) program for schizophrenia and other cognitive disorders. OMS824 selectively inhibits PDE10, which is an enzyme expressed in areas of the brain linked to diseases that affect cognition, including schizophrenia and Huntington's disease.
The first clinical trial evaluating OMS824 is expected to commence following the FDA's review of the IND. This Phase 1 dose-ranging study will evaluate the drug's safety, tolerability and pharmacokinetics in healthy subjects and, assuming timely clearance by the FDA, Omeros plans to begin enrollment in the fourth quarter of 2012 with data expected before year end.
"The deep and diverse pipeline behind our PharmacoSurgery™ platform has now begun to yield clinical programs," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "OMS824 represents the first new chemical entity developed wholly within Omeros that has progressed from discovery through preclinical development and is now poised to enter the clinic, underscoring our in-house capabilities to generate promising novel compounds and build them into clinical assets. Together with our Phase 1 trial results for OMS824, we also expect to announce data later this year from our two ongoing Phase 3 clinical development programs, OMS302 for ophthalmology and OMS103HP for arthroscopy."
About Omeros' PDE10 Program
PDE10 is an enzyme that is expressed in areas of the brain linked to diseases that affect cognition, including schizophrenia and Huntington's disease. Cognitive dysfunction occurs early in these diseases and is responsible for substantial disability. Omeros' proprietary compound OMS824 inhibits PDE10 and is being developed for the treatment of cognitive disorders, including schizophrenia where OMS824 could also have a beneficial effect on the positive and negative symptoms of the disease. Omeros' PDE10 program has been funded by The Stanley Medical Research Institute against milestones.