Omeros has obtained regulatory authority and ethics committee clearance to start the Phase 1 clinical trial evaluating its lead phosphodiesterase 7 (PDE7) inhibitor from the company’s OMS527 program. Omeros discovered the link between PDE7 and addiction, and the company holds broad patents internationally directed to PDE7 inhibitors for the treatment of all addictions and compulsive disorders. The Phase 1 clinical trial will evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of the compound in healthy subjects. First subject dosing is expected next month. Following Phase 1 completion, Omeros plans to conduct its initial OMS527 Phase 2 clinical trial in patients with nicotine addiction.
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Omeros also identified the mechanism by which its proprietary PDE7 inhibitors modulate dopamine levels in the areas of the brain responsible for addiction. The dopamine system is well recognized as the brain’s primary driver in drug addiction and compulsive disorders. In animal models, Omeros’ PDE7 inhibitors reduce craving and relapse across multiple drugs of abuse, including nicotine, cocaine, opioids and alcohol, and also block binge eating. Importantly, PDE7 inhibitors do not appear to be addictive nor to depress pleasure from normal activities, each of which are often shortcomings of current commercial addiction therapies.
“We look forward to initiating human dosing of OMS527,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “The monetary and societal costs of addictions and compulsions globally are staggering and continue to grow. These disorders represent an enormous and urgent unmet need, with currently available treatment regimens falling short. We’re excited about the prospects of PDE7 inhibition to change fundamentally that treatment paradigm.”