Omeros has filed an investigational new drug application (IND) with the FDA for OMS824, the compound from its phosphodiesterase 10 (PDE10) program for schizophrenia and other cognitive disorders.
OMS824 targets and inhibits an enzyme expressed in areas of the brain associated with diseases that affect cognition, including schizophrenia and Huntington's disease, PDE10.
Omeros chairman and chief executive officer Gregory Demopulos said OMS824 has progressed from discovery through preclinical development and is now poised to enter the clinic.
"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," Demopulos added.
Upon FDA's review of the IND, the company expects to commence first trial which will evaluate the safety, tolerability and pharmacokinetics of OMS824 in healthy subjects.
