Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OMS906 · 2 trials · 1 indication
Number and % of participants with Treatment-emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0, including abnormalities in laboratory measures, ECGs and physical examinations
Number and % of participants with Treatment-emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0, including abnormalities in laboratory measures, ECGs and physical examinations.
| Arm | Type | Description |
|---|---|---|
| 3 mg/kg IV OMS906 with Ravulizumab IV | EXPERIMENTAL | Up to 6 doses of 3 mg/kg at 8-week intervals. All patients will receive 3 doses of OMS906 of 3 mg/kg Intravenous (IV) at 8-week intervals. Clinical responders at Week 24 will receive an additional 3 doses of OMS906 only at 8-week intervals at 5 mg/kg (monotherapy). Incomplete responders may receive an additional 3 doses of OMS906 with ravulizumab at 8-week intervals. Non responders will not receive additional OMS906. |
| 5 mg/kg IV OMS906 with Ravulizumab IV | EXPERIMENTAL | Up to 6 doses of 5 mg/kg at 8-week intervals. All patients will receive 3 doses of OMS906 of 5 mg/kg Intravenous (IV) at 8-week intervals. Clinical responders at Week 24 will receive an additional 3 doses of OMS906 only at 8-week intervals (monotherapy). Incomplete responders may receive an additional 3 doses of OMS906 with ravulizumab at 8-week intervals. Non responders will not receive additional OMS906. |
| OMS906 study drug administration in three phases | EXPERIMENTAL | 1. 5 mg/kg SC administered every 4 weeks (Q4W), 2. 5 mg/kg IV administered once followed by administration of additional doses of 5 mg/kg IV at the occurrence of protocol-defined subclinical breakthrough hemolysis, and 3.) 8 mg/kg IV every 8 weeks (Q8W) on a fixed-dosing (FD) schedule |
| Name | Type | Description |
|---|---|---|
| OMS906 | BIOLOGICAL | Biological: OMS906 |
Inclusion Criteria: 1. Confirmed diagnosis of PNH by flow cytometry with PNH clone size of \> 10% red blood cells (RBCs) and/or granulocytes. 2. Male or female adults 18 years and older. 3. Completed informed consent procedures. 4. In relation to ravulizumab treatment prescribed in accordance with ...
OMS906 is an investigational monoclonal antibody being developed for paroxysmal nocturnal hemoglobinuria (PNH), a rare hematologic disorder. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
OMS906 is being developed by Omeros Corporation, a biopharmaceutical company traded on NASDAQ under the ticker OMER. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with paroxysmal nocturnal hemoglobinuria.
OMS906 is in Phase 2 clinical development for paroxysmal nocturnal hemoglobinuria. It has completed two clinical trials, including a Phase 1 study and a Phase 2 study, and remains an investigational drug that is not yet approved.
OMS906 has been studied in two completed clinical trials. NCT05889299 was a Phase 1 study in 15 patients with paroxysmal nocturnal hemoglobinuria in Ukraine. NCT05972967 was a Phase 2 study in 12 patients with a sub-optimal response to ravulizumab, conducted in Germany, Greece, Switzerland, and the United Kingdom.
OMS906 is a monoclonal antibody, a type of biologic drug designed to bind to a specific target involved in the disease process. In paroxysmal nocturnal hemoglobinuria, it is being investigated for its ability to address the underlying complement system dysregulation, though the precise molecular target is not specified.