Omeros: FDA Grants Fast Track Status To OMS824 Huntington's Disease Program

(RTTNews) - Omeros Corp. (OMER) Wednesday said the U.S. Food and Drug Administration granted Fast Track designation to OMS824, the company's phosphodiesterase 10 or 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 several 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. 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, which have the potential to address unmet medical needs.