Omeros Initiates Phase 2 Clinical Trial with OMS824

Omeros Corporation

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