The US Food and Drug Administration (FDA) has cleared Omeros' investigational new drug application (IND) for OMS824 in Huntington's disease.
OMS824 is developed to selectively inhibit phosphodiesterase 10 enzyme that is expressed in areas of the brain associated with an array of diseases affecting cognition, such as Huntington's disease and schizophrenia.
Omeros chairman and chief executive officer Gregory Demopulos said currently there are no drugs available for the improvement of cognition in either Huntington's disease or schizophrenia.
"In Huntington's disease, OMS824 also has the potential to improve motor control and to reduce the rate of neurodegeneration, slowing disease progression," Demopulos added.
As the investigational agent was well tolerated and established favorable pharmacokinetic properties in Phase 1 clinical program, the company is planing to advance it into phase 2 trials for Huntington's disease in the next quarter of 2013 and for schizophrenia later in 2014.
The US regulator had previously cleared OMS824 IND for use in schizophrenia patients.
The company is seeking orphan drug designation and fast track designation for the candidate in the treatment of Huntington's disease from the FDA.
