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Omeros Announces Successful Completion of PDE10 Phase 1 Multiple Ascending Dose Trial
Date:3/26/2013

SEATTLE, March 26, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced positive data from the multiple-ascending-dose (MAD) portion of the Company's Phase 1 clinical trial evaluating OMS824, the lead compound in Omeros' phosphodiesterase 10 (PDE10) program. With these data and the previously announced successful single-ascending-dose portion of this clinical trial, Omeros is advancing OMS824 toward a Phase 2 clinical program. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia.

The OMS824 Phase 1 clinical trial was a randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study. The trial enrolled 64 healthy male subjects; 40 subjects received a single dose and 24 subjects received daily dosing for 7 to 10 days. OMS824 was well tolerated by all subjects, and the only apparent drug-related adverse event was mild somnolence at the highest dose evaluated. No subject had extrapyramidal symptoms (e.g., involuntary muscle movements), which are associated with marketed antipsychotic medications and have been seen with other companies' PDE10 inhibitors at levels of approximately 50-percent engagement of the PDE10 enzyme in the brain. A radiotracer imaging study is underway to confirm the target engagement of OMS824 in human brains.

The study results showed that the pharmacokinetic parameters (Cmax and AUC) increased linearly with the dose and that OMS824 had a long half-life that is consistent with once daily dosing. OMS824 was detected in the cerebrospinal fluid at the expected concentration relative to that in the blood. The drug concentration in the cerebrospinal fluid is predicted to achieve near-complete inhibition of the PDE10 target in the brain. These resul
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