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Omeros Reports Positive Results from New Medication Phase 2 Clinical Trial for Schizophrenia

by on March 17, 2014
 

A new research report gives hope to families and people who suffer from schizophrenia that there may soon be a new medication that helps with the negative and cognitive symptoms that are so common with schizophrenia.

Omeros Corporation recently announced additional positive results from a Phase 2a clinical trial of OMS824, the company’s phosphodiesterase 10 (PDE10) inhibitor. Patients with schizophrenia were administered a higher dose than had been evaluated in any OMS824 trial. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia.

The results reported today were in psychiatrically stable patients who continued their usual antipsychotic regimen and received OMS824 or placebo for 14 days.

The positive results across all doses tested in this Phase 2a trial indicate that OMS824 can be administered in combination with standard antipsychotic medications. Future Phase 2 and Phase 3 clinical trials in Omeros’ schizophrenia program may evaluate OMS824 both as a single agent and as adjunctive treatment for cognitive impairment, acute exacerbation of symptoms, and/or inadequate response to antipsychotic medications.

“We are pleased with how OMS824 continues to perform over a wide range of dosing across multiple clinical trials — whether administered to healthy volunteers or patients with schizophrenia, the molecule has demonstrated remarkable tolerability at high plasma levels and, likely, at even higher target interaction than we have measured to date,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros.  “We look forward to completing the PET cohort and to evaluating the compound’s efficacy in our ongoing Phase 2 program in patients with schizophrenia.”

About Omeros’ PDE10 Program PDE10 is an enzyme that is expressed in areas of the brain linked to diseases that affect cognition and psychomotor functions, including Huntington’s disease and schizophrenia.  Cognitive dysfunction is responsible for substantial disability in schizophrenia and is not meaningfully improved by current medications. Omeros’ proprietary compound OMS824, currently in Phase 2 clinical programs, inhibits PDE10 and is being developed for the treatment of cognitive disorders. In addition to potential benefits on cognition, OMS824 could also improve the motor and psychiatric abnormalities in Huntington’s disease as well as the positive (e.g., hallucinations) and negative (e.g., flat affect) symptoms of schizophrenia. Omeros has been awarded Orphan Drug designation by the US FDA to evaluate OMS824 in Huntington’s disease, and received Fast Track designation from the FDA for the development of OMS824 to treat cognitive impairment in Huntington’s disease. An application for Fast Track designation for the evaluation of OMS824 in schizophrenia is currently under FDA review.

More about Omeros Corp:  http://www.omeros.com/

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