— Phase 2 Clinical Trial in Huntington’s Disease Slated to Begin This Year —
SEATTLE, Sept. 30, 2013 /PRNewswire/ — Omeros Corporation (NASDAQ: OMER) announced that OMS824, its phosphodiesterase 10 (PDE10) inhibitor, has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of 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. As previously reported, Phase 1 clinical results in healthy subjects demonstrated that OMS824 is well tolerated and suggest that it has a better clinical therapeutic index or “safety factor” than other PDE10 inhibitors in development. Omeros plans to begin a Phase 2 clinical trial evaluating OMS824 in patients with Huntington’s disease later this year. A Phase 2 clinical trial of the drug is already underway in patients with schizophrenia.
Orphan designation by the FDA is granted to promote the development of drugs that target conditions affecting 200,000 or fewer U.S. patients annually and that are expected to provide significant therapeutic advantage over existing treatments. It qualifies a company for benefits that apply across all stages of drug development, including accelerated approval process, seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees.
Huntington’s disease is estimated to affect approximately 31,000 U.S. patients annually, and the only FDA‑approved treatment for the disease is tetrabenazine, which is indicated for Huntington’s-related movement disorders. OMS824 has the potential to improve the cognitive and psychiatric abnormalities as well as the movement disorders associated with the disease.
“Orphan designation by the FDA will help to accelerate the development of OMS824 and recognizes the important work conducted at Omeros,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer ofOmeros. “The manifestations of Huntington’s are devastating to both Huntington’s patients and their families, yet there is only one currently approved therapeutic and it is focused on a single symptom of the disease. OMS824 holds the promise of expanding treatment across the constellation of debilitating effects of Huntington’s. We look forward to working with the FDA to advance the clinical evaluation of OMS824 in patients suffering from Huntington’s disease and plan to initiate enrollment in a Phase 2 trial later this year.”
About Omeros’ PDE10 Program
PDE10 is an enzyme that is expressed in areas of the brain linked to diseases that affect cognition and psychomotor functions, including Huntington’s disease and schizophrenia. Huntington’s disease is a hereditary neurodegenerative disorder that leads to movement, cognition, and behavioral abnormalities and premature death. Schizophrenia is a group of severe brain disorders characterized by an abnormal interpretation of reality, which can manifest as delusions, hallucinations, and/or disordered thinking and behavior. Cognitive dysfunction is responsible for substantial disability in both of these diseases and is not meaningfully improved by current medications. Omeros’ proprietary compound OMS824 inhibits PDE10 and is being developed for the treatment of cognitive disorders. In addition to potential benefits on cognition, OMS824 could also improve the motor and psychiatric abnormalities in Huntington’s disease as well as the positive (e.g., hallucinations) and negative (e.g., flat affect) symptoms of schizophrenia.
Source: Omeros Corporation
Omeros Huntington’s Disease Drug Granted Orphan Status
Wall Street Journal –
Omeros Corp. (OMER) said its treatment for Huntington’s disease was granted orphan drug status by the U.S. Food and Drug Administration, accelerating the drug’s development. Orphan drug designation is granted by the FDA for novel drugs or biologics that …
FDA Grants Orphan Drug Designation to Omeros’ OMS824 for Huntington’s …
SEATTLE, Sept. 30, 2013 /PRNewswire via COMTEX/ — Omeros Corporation (NASDAQ:OMER) announced that OMS824, its phosphodiesterase 10 (PDE10) inhibitor, has received orphan drug designation from the U.S. Food and Drug Administration for the …
OMEROS CORPORATION : FDA Grants Orphan Drug Designation to Omeros …
4-traders (press release) –
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. As previously reported, Phase 1 clinical results in healthy subjects …