Clinical-stage biopharmaceutical company Omeros Corp. (OMER) Tuesday announced positive data from the multiple-ascending-dose portion of the company's early stage clinical trial evaluating OMS824, the lead compound in its phosphodiesterase 10 or PDE10 program. The company thus is expected to advance OMS824 towards a mid stage 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 enrolled 64 healthy male subjects, in which 40 subjects received a single dose and 24 subjects received daily dosing for 7 to 10 days. The company said OMS824 was well tolerated by all subjects, and the only apparent adverse event was mild somnolence at the highest dose evaluated. The firm further said the results show that OMS824, at well-tolerated doses, achieves concentrations that are anticipated to effectively inhibit PDE10 and support continuing development for the treatment of Huntington's disease, schizophrenia and other central nervous system disorders.
Commenting on future plans, Gregory Demopulos, CEO of Omeros said, "While wrapping up the Phase 1 program, we are aggressively advancing OMS824 into Phase 2 trials. Our initial focus will be Huntington's disease, for which we will be requesting orphan drug as well as Fast Track designations from the FDA, and a Phase 2a trial in patients with schizophrenia is expected to follow shortly thereafter."
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