Omeros Reports Additional Positive Data from its OMS824 Phase 2a Schizophrenia Clinical Trial -- Significantly Higher Drug Exposure Achieved with Continued Tolerability --
SEATTLE, March 6, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced additional positive results from a Phase 2a clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor. Patients with schizophrenia were administered a higher dose than had been evaluated in any OMS824 trial, which resulted in approximately 50 percent higher plasma concentrations than did the previously reported highest dose and had a similar side-effect profile to those of the lower doses. 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.
The results reported today were in psychiatrically stable patients who continued their usual antipsychotic regimen and received OMS824 or placebo for 14 days. Despite achieving approximately 50 percent higher plasma concentrations of OMS824 than previously reached at the next-highest dose in the Phase 2a trial, OMS824 was tolerated with mild or moderate adverse events that were consistent with those seen in previous cohorts, were self-limited and did not result in any discontinuation of the drug. The drug concentrations in these schizophrenia patients were also approximately 50 percent higher than levels that corresponded to an average of 66 percent target interaction (a high of approximately 70 percent) at PDE10 in a Phase 1 positron emission tomography (PET) trial in healthy subjects. To date, the OMS824 PET trial has demonstrated significantly higher target interaction at PDE10 without extrapyramidal symptoms (loss of muscle control, e.g., muscle rigidity, tremors, or involuntary muscle movements) than has been reported for any other PDE10 inhibitor in development. An additional PET trial cohort is planned in the coming weeks.
The positive results across all doses tested in this Phase 2a trial indicate that OMS824 can be administered in combination with standard antipsychotic medications and that, at tolerated doses, yields plasma concentrations that are predicted to achieve a high degree of PDE10 target interaction in the striatum. 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.
"We are pleased with how OMS824 continues to perform over a wide range of dosing across multiple clinical trials -- whether administered to healthy volunteers or patients with schizophrenia, the molecule has demonstrated remarkable tolerability at high plasma levels and, likely, at even higher target interaction than we have measured to date," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We look forward to completing the PET cohort and to evaluating the compound's efficacy in our currently enrolling Phase 2 Huntington's trial and our ongoing Phase 2 program in patients with schizophrenia."
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 received Fast Track designation from the FDA for the development of OMS824 to treat cognitive impairment in Huntington's disease. An application for Fast Track designation for the evaluation of OMS824 in schizophrenia is currently under FDA 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, Omidria™ (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 US commercial launch planned for the second half of 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," "look forward to", "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