Omeros Corporation announced that the FDA has granted OMS824 a Fast Track Designation for the treatment of cognitive impairment in patients with Huntington’s disease. It previously also received an Orphan Drug Designation by the FDA.
OMS824 selectively inhibits phosphodiesterase 10 (PDE10), an enzyme found in areas of the brain linked to a wide range of diseases that affect cognition and psychomotor functions. It has been shown to improve the motor and psychiatric abnormalities in Huntington’s disease patients, as well as symptoms of schizophrenia.
Phase 1 clinical trials showed success in assessing the safety, tolerability, pharmacokinetics and target engagement of a variety of doses of OMS824 for Huntington’s Disease patients. Omeros will begin enrolling patients for its Phase 2 trial this quarter.
For more information call (206) 676-5000 or visit Omeros.com.