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IND application filed for a Phase I Clinical Trial of a PDE10 inhibitor
In the Press Release below, we learn that Omeros has filed an IND for a Phase I clinical trial for its PDE10 inhibitor. This is good news for the HD community since preclinical data, which we reported last year, shows that it might be helpful for HD patients, treating both the disease and its symptoms.
For example, in one study, R6/2 mice were treated with a PDE10A inhibitor from 4 weeks of age until they were euthanized at 13 weeks. Both neuropathology and symptoms were ameliorated. Cell loss in the cortex and the striatum was reduced, there were fewer intranuclear aggregates in the striatal neurons, and the degree of microglia activation was decreased. Behavioral symptoms such as rotarod performance were also improved over untreated mice.
We will keep reporting information about the proposed trial as we receive it.
- Marsha L. Miller, Ph.D., September 6, 2012
Omeros Files Investigational New Drug Application for Lead Compound in PDE10 Program-- Data from First Phase 1 Clinical Trial Expected in 2012
SEATTLE, Sept. 6, 2012 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) to initiate clinical trials evaluating OMS824, the Company's lead compound from its phosphodiesterase 10 (PDE10) program for schizophrenia and other cognitive disorders. OMS824 selectively inhibits PDE10, which is an enzyme expressed in areas of the brain linked to diseases that affect cognition, including schizophrenia and Huntington's disease.
The first clinical trial evaluating OMS824 is expected to commence following the FDA's review of the IND. This Phase 1 dose-ranging study will evaluate the drug's safety, tolerability and pharmacokinetics in healthy subjects and, assuming timely clearance by the FDA, Omeros plans to begin enrollment in the fourth quarter of 2012 with data expected before year end.
"The deep and diverse pipeline behind our PharmacoSurgery™ platform has now begun to yield clinical programs," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "OMS824 represents the first new chemical entity developed wholly within Omeros that has progressed from discovery through preclinical development and is now poised to enter the clinic, underscoring our in-house capabilities to generate promising novel compounds and build them into clinical assets. Together with our Phase 1 trial results for OMS824, we also expect to announce data later this year from our two ongoing Phase 3 clinical development programs, OMS302 for ophthalmology and OMS103HP for arthroscopy."
About Omeros' PDE10 Program
PDE10 is an enzyme that is expressed in areas of the brain linked to diseases that affect cognition, including schizophrenia and Huntington's disease. Cognitive dysfunction occurs early in these diseases and is responsible for substantial disability. Omeros' proprietary compound OMS824 inhibits PDE10 and is being developed for the treatment of cognitive disorders, including schizophrenia where OMS824 could also have a beneficial effect on the positive and negative symptoms of the disease. Omeros' PDE10 program has been funded by The Stanley Medical Research Institute against milestones.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system. The Company's most clinically advanced product candidates are derived from its proprietary PharmacoSurgery™ platform designed to improve clinical outcomes of patients undergoing a wide range of surgical and medical procedures. Omeros has four ongoing clinical development programs. Omeros may also have the near-term capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Behind its clinical candidates and GPCR platform, Omeros is building a diverse pipeline of protein and small-molecule preclinical programs targeting inflammation, coagulopathies and central nervous system disorders.
This press release contains forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, which are subject to the "safe harbor" created by those sections. These statements include, but are not limited to, Omeros' expectations regarding when it will commence enrollment in and announce data from its Phase 1 clinical trial evaluating OMS824; the potential clinical benefits of OMS824; Omeros' plans to announce data from its ongoing Phase 3 clinical trials evaluating OMS302 and OMS103HP during the fourth quarter of 2012; and that Omeros may have capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. 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, 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 August 7, 2012. 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 publicly, even if new information becomes available in the future.
SOURCE Omeros Corporation