Omeros Corporation (NASDAQ: OMER) today announced positive results from a Phase 2a clinical trial of OMS824, the company’s phosphodiesterase 10 (PDE10) inhibitor, in which the drug was well tolerated and demonstrated comparable systemic pharmacokinetics when administered alone and concomitantly with approved antipsychotic agents in patients with schizophrenia. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia and Huntington’s disease.
In this Phase 2a randomized, double-blind, placebo-controlled trial, OMS824 was administered at two dose levels for two weeks to psychiatrically stable patients whose antipsychotic medications were temporarily discontinued or who continued their usual antipsychotic regimen. The trial enrolled 33 patients, and the results showed that OMS824 was well tolerated, with mild or moderate adverse events that were self-limited and resolved during the treatment period. The tolerability and pharmacokinetics of OMS824 were not affected by concomitant antipsychotic medications, allowing the drug to be developed as both a monotherapy and as adjunctive therapy in combination with currently approved antipsychotics. The plasma concentrations of OMS824 in the high-dose cohort were similar to levels that corresponded to greater than 60 percent target occupancy of PDE10 in a Phase 1 positron emission tomography (PET) trial. Given the small sample size, efficacy conclusions cannot be drawn but the data support continued development in schizophrenia and other neuropsychiatric conditions.
The positive results from this Phase 2a trial suggest that dose adjustment will not be necessary when OMS824 is administered in combination with standard antipsychotic medications. Future Phase 2 and Phase 3 clinical trials in Omeros’ schizophrenia program may evaluate OMS824 both as a single agent and as adjunctive treatment for cognitive impairment, acute exacerbation of symptoms, and/or inadequate response to antipsychotic medications.
“PDE10 is a novel target for the treatment of schizophrenia and other neuropsychiatric disorders with the potential to address limitations of current therapy,” stated Michael Davidson, M.D., Professor in the Department of Psychiatry, Sackler School of Medicine, Tel Aviv University, Israel. “Inhibition of PDE10, which is a novel mechanism of action, may be able to treat not only the positive symptoms in schizophrenia but also the negative symptoms and cognitive impairment. The OMS824 data are the most promising of any PDE10 inhibitor, and I am eager to review additional clinical data for Omeros’ drug product.”
“We are excited by these positive clinical results,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “Based on the favorable tolerability and pharmacokinetics of OMS824, we are considering evaluating additional higher dose levels in patients with schizophrenia. The data from the current trial open the door to developing OMS824 as monotherapy or in conjunction with other antipsychotics for schizophrenia and a wide range of other psychiatric and neurologic disorders.”
In addition to its schizophrenia program, Omeros expects to begin enrollment this quarter in a Phase 2 clinical trial evaluating OMS824 in patients with Huntington’s disease.
About Omeros’ PDE10 Program
PDE10 is an enzyme that is expressed in areas of the brain linked to diseases that affect cognition and psychomotor functions, including Huntington’s disease and schizophrenia. Huntington’s disease is a hereditary neurodegenerative disorder that leads to movement, cognition, and behavioral abnormalities and premature death. Schizophrenia is a group of severe brain disorders characterized by an abnormal interpretation of reality, which can manifest as delusions, hallucinations, and/or disordered thinking and behavior. Cognitive dysfunction is responsible for substantial disability in both of these diseases and is not meaningfully improved by current medications. Omeros’proprietary compound OMS824, currently in Phase 2 clinical programs, inhibits PDE10 and is being developed for the treatment of cognitive disorders. In addition to potential benefits on cognition, OMS824 could also improve the motor and psychiatric abnormalities in Huntington’s disease as well as the positive (e.g., hallucinations) and negative (e.g., flat affect) symptoms of schizophrenia. Omeros has been awarded Orphan Drug Designation by the US FDA to evaluate OMS824 in Huntington’s disease, and Fast Track applications to the FDA for the evaluation of OMS824 in Huntington’s disease and schizophrenia, respectively, are currently under review.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics targeting inflammation, coagulopathies and disorders of the central nervous system. Derived from its proprietary PharmacoSurgery® platform, the Company’s lead drug product, OMS302 for lens replacement surgery, is currently under review for marketing approval by both the US Food and Drug Administration and the European Medicines Agency with commercial launch planned for 2014. Omeros’ five other clinical programs are focused on schizophrenia, Huntington’s disease and cognitive impairment; addictive and compulsive disorders; complement-related diseases; and preventing problems associated with surgical procedures. Omeros also has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with Omeros’ unproven preclinical and clinical development activities, regulatory oversight, product commercialization, intellectual property claims, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2013. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.
SOURCE Omeros Corporation