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news.US-based biopharmaceutical company Omeros has started dosing first patient in a second Phase II clinical trial of its phosphodiesterase 10 (PDE10) inhibitor OMS824 for the treatment of schizophrenia, Huntington's disease (HD) and other cognitive disorders.
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The trial is designed to evaluate the tolerability, safety, pharmacokinetics and performance on a battery of tests in patients with symptomatic HD.
Around 120 patients with Huntington’s disease will be enrolled in the second Phase II trial and they will be randomized to receive placebo or one of three doses of OMS824.
The company said that the dose levels were selected based on tolerability and PDE10 target occupancy results in Phase I studies conducted in healthy patients.
The doses assessed in the second Phase II trial is expected to be well tolerated and cover a range of PDE10 target occupancy in the brain.
The efficacy in the trial will be evaluated across three functional domains that are affected by the disease: motor, cognitive, and behavior.
In the trial, patients are allowed to continue their usual medications based on the results of the earlier Phase II trial in which schizophrenia patients who took similar classes of drugs had no untoward interactions with OMS824.
The company said that interim results are expected in the second half of 2014 with final data scheduled to be available in 2015.