(By Balaseshan) Omeros Corp. (NASDAQ:OMER) said it has filed an investigational new drug application (IND) for its lead compound in phosphodiesterase 10 (PDE10) program to treat schizophrenia and other cognitive disorders.
The company has filed an IND with the U.S. Food and Drug Administration (FDA) to initiate clinical trials evaluating OMS824, its 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. Cognitive dysfunction occurs early in these diseases and is responsible for substantial disability.
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 intends to begin enrollment in the fourth quarter of 2012 with data expected before year end.
"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," said Gregory Demopulos, chief executive of Omeros.
Together with its Phase 1 trial results for OMS824, the company also expects to announce data later this year from its two ongoing Phase 3 clinical development programs, OMS302 for ophthalmology and OMS103HP for arthroscopy.
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.
OMER closed Wednesday's regular session down 2.63% at $9.25. The stock has been trading between $3.21 and $13.45 for the past 52 weeks.