Omeros Corporation (OMER), a clinical-stage biopharmaceutical company, Thursday said that the FDA has cleared its Investigational New Drug Application or IND to evaluate OMS824 in Huntington's disease. OMS824 selectively inhibits phosphodiesterase 10 (PDE10), an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia.
The company also announced today that it has requested Orphan Drug Designation from the FDA for OMS824. Orphan-designated drugs are eligible for incentives such as a faster approval process and additional market exclusivity. Recently, Omeros had also announced that it has requested Fast Track designation for OMS824. Fast Track designation is reserved for drugs being developed to treat life-threatening conditions with the potential to address unmet medical needs and typically provides priority review status.
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