Omeros Corporation (OMER), a clinical-stage biopharmaceutical company, has started enrolment in a Phase II clinical trial of OMS824, the company’s phosphodiesterase 10 (PDE10) inhibitor, to treat patients with stable schizophrenia.
According to the company, the Phase II study will assess the compound’s tolerability, safety, pharmacokinetics, potential interactions with concomitant antipsychotic medications, and a battery of cognitive tests in patients with stable schizophrenia.
During the new trial, the compound will be administered at several dose levels for two weeks to patients whose antipsychotic medications have been temporarily stopped or who continue their usual antipsychotic regimen to evaluate the effects of it as monotherapy and in combination with antipsychotic medications.
In addition, several other cognitive tests will be analysed during the Phase II trial.
Omeros chairman and CEO Gregory Demopulos said: "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."
The safety and any efficacy data secured in the new trial will be used use to determine suitable dosing regimens and endpoints for the next stage of Phase II and Phase III clinical trials in schizophrenia.
According to the company, these trials are expected to assess 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.
Results from a Phase I clinical study supported the advancement of OMS824 into patient-directed trials with establishment of dosing regimens that were well tolerated and associated with high levels of PDE10 target engagement in the brain.
PDE10 is an enzyme that is expressed in areas of the brain related to diseases that affect cognition and psychomotor functions, as well as Huntington’s disease and schizophrenia.
Schizophrenia is a group of severe brain disorders involving people interpreting reality abnormally; it may result in some combination of hallucinations, delusions, disordered thinking and behaviour.
Omeros’s proprietary compound OMS824 is being developed for the treatment of cognitive disorders; it also improves the motor and psychiatric abnormalities in Huntington’s disease as well as the positive and negative symptoms of schizophrenia.
Image: Image showing brain areas more active in controls than in schizophrenia patients during a working memory task during an MRI study. Photo: courtesy of Kim J, Matthews NL, Park S.