Sep 19 2013
Omeros Corporation (NASDAQ: OMER) today announced initiation of enrollment in a Phase 2 clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor. The trial will evaluate the compound's tolerability, safety, pharmacokinetics, potential interactions with concomitant antipsychotic medications, and a battery of cognitive tests in patients with stable schizophrenia.
The Phase 1 clinical program in healthy subjects established dosing regimens that were well tolerated and associated with high levels of PDE10 target engagement in the brain, supporting advancement of OMS824 into patient-directed trials. In this Phase 2 clinical trial, OMS824 will be administered at various dose levels for two weeks to patients whose antipsychotic medications have been temporarily discontinued or who continue their usual antipsychotic regimen in order to assess the effects of OMS824 as monotherapy and in combination with antipsychotic medications. A variety of cognitive tests will be assessed, although the relatively small size of this trial will limit the ability to detect treatment effects, if present. The safety and any efficacy findings in this trial are planned for use in determining appropriate dosing regimens and selecting endpoints for subsequent Phase 2 and Phase 3 clinical trials in schizophrenia. Those trials are expected to evaluate OMS824 in schizophrenic patients who are psychiatrically stable with cognitive impairment, in patients with acute exacerbation of symptoms, and/or in patients with inadequate response to antipsychotic medications.
"We are excited to begin assessing OMS824 in patients suffering with schizophrenia," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "This Phase 2 trial will provide us with important information on our compound's safety and, potentially, efficacy for additional Phase 2 trials in schizophrenia and Huntington's disease. We look forward to completing the current trial later this year."
SOURCE Omeros Corporation