The results reported were in healthy male subjects receiving OMS824 once daily for seven days at a dose higher than those previously evaluated in the target-engagement clinical trial. Positron emission tomography (PET) scans were used to measure the binding activity of OMS824 to PDE10 in the brain. An average of 63-percent occupancy at PDE10 was seen in the basal ganglia, the region of the brain that plays a critical role in cognition. The drug was well tolerated with mild somnolence as the only apparent side effect.
While the level of target engagement seen in this PET trial is significantly higher with lesser side effects than has been reported for any other PDE10 inhibitor in development, a recently completed Phase 1 clinical pharmacokinetic trial with 10 days of OMS824 dosing achieved approximately 50 percent higher plasma concentrations than in the PET trial, and all side effects were mild and well-tolerated, and most were self-limiting. PET data were not obtained in this pharmacokinetic trial but, based on modeling of all data obtained in the OMS824 Phase 1 program, it is estimated that the drug engaged the PDE10 enzyme at levels substantially greater than 63 percent.
Effective inhibition of PDE10 is considered a novel and promising mechanism to treat Huntington's disease, schizophrenia and other central nervous system disorders.
"We are encouraged by the continued stream of positive data from our PDE10 program," stated
Keywords for this news article include: Chorea, Dementia, Dyskinesias, Brain Diseases, Movement Disorders,
Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2013, NewsRx LLC
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