Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OMS721 · 1 trial · 1 indication
Incidence of treatment-emergent adverse events (AEs): clinically significant changes in vital signs, ECG, and laboratory tests were reported as AEs.
Response defined as: Improvement in TMA laboratory markers of platelet count and lactate dehydrogenase (LDH) and improvement in clinical status
| Arm | Type | Description |
|---|---|---|
| OMS721 low dose | EXPERIMENTAL | Administration of OMS721 at a low dose |
| OMS721 medium dose | EXPERIMENTAL | Administration of OMS721 at a medium dose |
| OMS721 high dose | EXPERIMENTAL | Administration of OMS721 at a high dose |
| Name | Type | Description |
|---|---|---|
| OMS721 | BIOLOGICAL | - |
Inclusion Criteria: 1. Are at least age 18 at screening (Visit 1) 2. Have a diagnosis of primary aHUS, persistent HSCT-associated TMA or TTP 3. No clinically apparent alternative explanation for thrombocytopenia and anemia Exclusion Criteria: 1. Had eculizumab therapy within three months prior to...
OMS721 is an investigational monoclonal antibody being developed for thrombotic microangiopathies, a group of disorders characterized by blood clots in small vessels. It is currently in clinical development and has not been approved by regulatory authorities.
OMS721 is being developed by Omeros Corporation, a biopharmaceutical company traded on NASDAQ under the ticker symbol OMER. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with thrombotic microangiopathies.
OMS721 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational. It has not received regulatory approval and is still being studied for its safety and effectiveness in treating thrombotic microangiopathies.
OMS721 has one completed Phase 2 clinical trial, identified as NCT02222545, titled 'Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies.' The trial enrolled 58 participants across multiple countries, including the United States, Belgium, Bulgaria, Hong Kong, Italy, Lithuania, Malaysia, New Zealand, Poland, Singapore, Taiwan, and Thailand.
OMS721 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The completed trial, NCT02222545, evaluated its safety and efficacy in thrombotic microangiopathies, but the drug has not yet received marketing authorization from the FDA or other regulatory bodies.