— Omeros Has Notified FDA of Intent to Submit Investigational New Drug Application this Quarter —
SEATTLE, July 18, 2012 /PRNewswire/ — Omeros Corporation (NASDAQ: OMER) today reported that OMS824, the lead compound in the Company’s phosphodiesterase 10 (PDE10) program for schizophrenia, has successfully completed all of the preclinical studies that Omeros expects will be necessary for the drug’s planned Investigational New Drug Application (IND). 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.
With these positive preclinical data, Omeros confirmed with the U.S. Food and Drug Administration (FDA) the Company’s intent to submit an IND for OMS824 during the current quarter. Following IND submission, Omeros is required to wait 30 days before enrolling patients into clinical trials to allow the FDA to review the IND to assure that OMS824 will not subject clinical trial patients to unreasonable risks. Omeros believes that the findings observed in the preclinical toxicology studies of OMS824 do not suggest any unreasonable safety risk to humans. Accordingly, the Company is preparing to begin enrolling patients in a Phase 1 dose-ranging clinical trial following the end of the required 30-day waiting period.
“Omeros’ PDE10 program is on track to report Phase 1 clinical trial data this year,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “Our two Phase 3 programs also remain on schedule, and we expect to read out data later this year from our ongoing trials evaluating OMS302 in lens replacement surgery and OMS103HP in arthroscopic meniscectomy procedures. We have already begun building the NDA for OMS302, which we plan to submit early next year. Our other programs are also advancing nicely, and we anticipate that a number of them will be ready to enter the clinic next year as well.”
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 focused on 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, bleeding 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, statements regarding the following expectations of Omeros: that it will be able to submit an IND to the FDA for OMS824 this quarter; that it will enroll patients in a Phase 1 clinical trial evaluating OMS824 following the required 30-day post-IND submission waiting period; that it will complete the Phase 1 clinical trial this year; that it will read out data from its ongoing Phase 3 clinical trials evaluating OMS302 and OMS103HP during the second half of this year; that a number of other Omeros programs will be ready to enter clinical trials next year; and that it will be able to unlock orphan GPCRs and 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 May 10, 2011. 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