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From Earlier: Investigational New Drug Application Cleared for Omeros' Lead Compound in PDE10 Program


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.

Posted-In: News FDA


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