Omeros Corporation, a clinical-stage biopharmaceutical company, has reported that OMS824, the lead compound in the company's phosphodiesterase 10 (PDE10) programme 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 US 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 I dose-ranging clinical trial following the end of the required 30-day waiting period.
“Omeros' PDE10 programme is on track to report phase I clinical trial data this year,” said Gregory A Demopulos, MD, chairman and chief executive officer of Omeros. “Our two phase III programmes 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.”
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.
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.