Omeros Corporation (OMER)

[surf1944]

7:03AM Omeros: FDA grants Fast Track designation to Omeros' OMS824 Huntington's disease program (OMER) 11.25 :

Co announced that the 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.
"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."