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Omeros Corporation Awarded $6.69 Million Grant from the National Institute on Drug Abuse for its OMS527 Addiction Program
– Directs Company to Advance its Lead Proprietary PDE7 Inhibitor to Treat Cocaine Use Disorder – SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (Nasdaq: OMER)
About this update from Omeros Corporation
[{"type":"text","content":"\n– Directs Company to Advance its Lead Proprietary PDE7 Inhibitor to Treat Cocaine Use Disorder –\n\n\n SEATTLE--(BUSINESS WIRE)--\nOmeros Corporation (Nasdaq: OMER) today announced that it has been awarded a grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, to develop Omeros’ lead orally administered compound from its proprietary phosphodiesterase 7 (PDE7) program OMS527 for the treatment of cocaine use disorder (CUD). The grant is expected to provide $6.69 million over three years and is intended to support both preclinical cocaine interaction studies and a clinical study evaluating the safety and efficacy of OMS527 in patients with CUD.\n\n\nTo advance NIDA’s urgent medication development priorities for substance use disorders, Omeros submitted a grant application in 2022 to assess the potential of PDE7 inhibition as a treatment for CUD. Following peer review including leaders in the field from academia and industry, grant funding was awarded on April 7, 2023. The grant has two main objectives. The first is to conduct interaction/toxicology studies of OMS527 in rats and non-human primates. Although a prior clinical study demonstrated that the compound is well tolerated in humans, cocaine has inherent proconvulsant and adverse cardiovascular effects, so the U.S. Food and Drug Administration requires additional drug-interaction safety studies to ensure that any therapeutic candidate is safe in people with CUD who may use cocaine while in treatment. The second objective is the successful completion of a randomized, single-dose, double-blind, parallel-group, inpatient study comparing the safety and efficacy of Omeros’ lead oral PDE7 inhibitor to placebo in the treatment of adults with CUD who receive concurrent intravenous cocaine. In addition to initial efficacy data on the endpoints of cocaine liking and craving, OMS527 pharmacokinetic and pharmacodynamic data in the presence of concomitant cocaine administration will be collected.\n\n\nOmeros discovered the role of PDE7 in addiction and compulsion and elucidated the associated mechanism of action of PDE7 inhibition. PDE7 directly affects dopaminergic pathways in the brain. The dopamine axis is central to all addiction and compulsive disorders, and PDE7 inhibition modulates dopamine signaling in key areas of the brain responsibl...