Omeros announced that its Investigational New Drug Application to evaluate OMS824 in Huntington's disease has been cleared by the FDA. OMS824 selectively inhibits phosphodiesterase 10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia. OMS824 has shown promising results in animal models directly relevant to Huntington's disease and, as previously announced, OMS824 was well tolerated and exhibited favorable pharmacokinetic properties in a Phase 1 clinical program. Omeros plans to advance OMS824 into Phase 2 clinical trials for Huntington's disease next quarter and for schizophrenia later this year, the OMS824 IND for use in patients with schizophrenia having already been cleared by the FDA. Omeros also announced today that it has requested Orphan Drug Designation from the FDA for OMS824 in the treatment of Huntington's disease.
- Disease & Medical Conditions