|
|
News Breaks | | | | October 2, 2012 | | 07:05 EDT |  | OMER | Omeros announces clearance of IND for OMS824 by FDA
Omeros announced that the Company's OMS824 Investigational New Drug Application, or IND, has been cleared by the FDA. With this clearance, Omeros may commence enrollment in its Phase 1 clinical trial evaluating OMS824, the Company's lead compound from its phosphodiesterase 10 program for schizophrenia and other cognitive disorders. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia and Huntington's disease. The planned Phase 1 dose-ranging study will evaluate the drug's safety, tolerability and pharmacokinetics in healthy subjects, and Omeros expects clinical data before year end. | |
|
News For OMER From The Last 14 Days Check below for free stories on OMER the last two weeks. |
|
|
| June 13, 2013 | | 07:01 EDT | | OMER | Omeros obtains regulatory approval to initiate Phase 1 clinical trial for OMS721
Omeros announced that it has obtained regulatory clearance to start the Phase 1 clinical trial evaluating OMS721, the company's lead human monoclonal antibody from its mannan-binding lectin-associated serine protease-2 program. The first clinical trial with OMS721 will be conducted in Europe and will evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS721 administered subcutaneously in healthy subjects. Omeros plans to follow this study with a clinical trial evaluating OMS721 in patients with atypical hemolytic uremic syndrome, a rare but life-threatening form of thrombotic microangiopathy. Enrollment in the initial clinical trial is scheduled to begin next month. | |
|
|
|
|
|
|
