FDA Fast Tracks Omeros’ Huntington’s Program

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Omeros Corporation today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor, for the treatment of cognitive impairment in patients with Huntington's disease. OMS824 selectively inhibits 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. Omeros has conducted successful clinical trials assessing the safety, tolerability, pharmacokinetics and target engagement of a wide range of doses of OMS824 in its Phase 1 program. Positive data from the company's OMS824 Phase 2a schizophrenia trial were recently announced, and Omeros expects to begin enrolling patients this quarter in its Phase 2 trial evaluating OMS824 for Huntington's disease.

Feburary 5th, 2014

Omeros Corporation today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to OMS824, the company’s phosphodiesterase 10 (PDE10) inhibitor, for the treatment of cognitive impairment in patients with Huntington’s disease. OMS824 selectively inhibits 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. Omeros has conducted successful clinical trials assessing the safety, tolerability, pharmacokinetics and target engagement of a wide range of doses of OMS824 in its Phase 1 program. Positive data from the company’s OMS824 Phase 2a schizophrenia trial were recently announced, and Omeros expects to begin enrolling patients this quarter in its Phase 2 trial evaluating OMS824 for Huntington’s disease.

FDA’s Fast Track program facilitates the development of drugs intended to treat serious or life‑threatening conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval. Many drugs that receive Fast Track designation are also considered appropriate to receive Priority Review, and their respective New Drug Applications (NDAs) may be accepted by the FDA as a “rolling submission” in which portions of an NDA are reviewed before the complete application is submitted. Priority Review and rolling submission can each provide further acceleration of FDA’s approval process.

“FDA’s Fast Track designation of OMS824 for Huntington’s disease reflects the unmet need associated with cognitive impairment in Huntington’s patients and recognizes the drug’s potential to treat this condition… Together with the orphan drug status previously awarded OMS824 by the FDA for Huntington’s, we have the opportunity to streamline the development of this promising compound. We look forward to enrolling patients in our OMS824 Phase 2 clinical trial for Huntington’s disease within the next few weeks.”Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros

View the press release here.
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