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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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  1. SzAdmin

    Does this help:

    There are eight principal negative symptoms. These are:

    1. Apathy / Loss if interest in activities that used to be something they did

    The person may have a lack of interest in activities that previously were important to them such as their work or studies or recreational activities such as sports. They may also stop looking after themselves properly and their personal hygiene and appearance may suffer noticeably. They may be reluctant to leave the house or even their bedroom and may lie in bed for the larger part of the day.

    2. Absent, blunted or incongruous emotional responses

    People with schizophrenia experiencing negative symptoms may appear to display no reaction to good or bad news or to react inappropriately for instance laughing at sad news or appearing to become unhappy when hearing good news.

    3. Reductions in speech

    People with negative symptoms of schizophrenia may appear to have little interest in conversation and may give only very brief responses to questions. Their speech may be disrupted or there may be long pauses in the flow of their speech or in responding to conversation (known as poverty of speech). The ability to make small talk is often completely lost and this loss of vital communication skills can impact seriously on the person’s ability to take part in social activities or find employment7. This is also called alogia by doctors. In extreme cases the person may become completely mute.

    4. Social withdrawal (not seeing friends and family much)

    The person may shun social contact and may prefer to spend the larger part of the day and night by themselves. There is a general lack of will to interact with the world around them. This is called avolition by doctors

    5. Impaired attention / Difficulty concentrating

    There may be an obvious difficulty in concentrating during conversation and an inability to concentrate on even simple tasks.

    6. Anhedonia / Ability to experience pleasure

    This describes an inability to experience pleasure. People with schizophrenia who experience this often describe life as being grey or empty, devoid of the normal emotional ups and downs that we all take for granted7. Others have described it as feeling empty or hollow10.

    7. Sexual problems

    There may be a significant reduction or total absence of libido (sex drive), men may experience problems in achieving erections and both men and women may have problems achieving an orgasm (anorgasmia).

    8. Lethargy / Lack of Energy

    People with schizophrenia experiencing negative symptoms will often have a profound lack of energy and find it difficult to do any more than light activity. This may lead to them spending a large part of the day in bed or watching television.

    Cognitive symptoms

    They include the following:

    1. poor ability to absorb and interpret information and make decisions based on that information
    2. inability to sustain attention, and
    3. Poor ability to keep recently learned information in mind and use it right away

Continue the discussion at forum.schizophrenia.com/

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