OMS824 Investigational New Drug Application Cleared
Investigational New Drug Application Cleared for Omeros' Lead Compound in PDE10 Program
-- Data from First Phase 1 Clinical Trial Expected in 2012 --
SEATTLE, Oct. 2, 2012 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the Company's OMS824 Investigational New Drug Application (IND) has been cleared by the U.S. Food and Drug Administration (FDA). With this clearance, Omeros may commence enrollment in its Phase 1 clinical trial evaluating OMS824, the Company's lead compound from its phosphodiesterase 10 (PDE10) program for schizophrenia and other cognitive disorders.
OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia and Huntington's disease. The planned Phase 1 dose-ranging study will evaluate the drug's safety, tolerability and pharmacokinetics in healthy subjects, and Omeros expects clinical data before year end.
"PDE10 inhibitors, a new class of therapeutics, have been shown in preclinical studies to improve cognition without some of the side effects associated with many of the antipsychotics currently on the market," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "OMS824 is a highly selective and potent PDE10 inhibitor, and we look forward to evaluating its potential as a new and effective drug for patients with cognitive impairment."
About Omeros' PDE10
ProgramPDE10 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 (e.g., hallucinations) and negative (e.g., flat affect) symptoms of the disease.