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Also known as OMS906 study drug, zaltenibart
OMS906 · 4 trials · 3 indications
Number of participants with Adverse Events following dosing of OMS906.
Treatment-emergent adverse events, including clinically significant clinical laboratory tests, 12-lead electrocardiograms, vital signs, and physical examinations recorded as an adverse event.
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 |
|---|---|---|
| Study Drug OMS906 | EXPERIMENTAL | Repeat-dose OMS906 5 mg/kg IV administration at 4-week intervals |
| OMS906 study drug | EXPERIMENTAL | OMS906 study drug repeat-dose 5 mg/kg IV administration at 8-week intervals. |
| 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 study drug | DRUG | OMS906 study drug dose 5mg/kg IV administration at 4-week internals |
| OMS906 | BIOLOGICAL | Biological: OMS906 |
Inclusion Criteria: 1. Male or female adults 18 years and older. 2. Competent to provide informed consent and has completed informed consent procedures. 3. Diagnosis of C3G, including dense deposit disease, or ICGN confirmed by biopsy within 36 months of screening. 4. Two 24-hour UPCR ≥ 0.8 gm/gm w...
OMS906 is an investigational small molecule developed by Omeros Corporation for complement-mediated diseases. It is being studied in C3 glomerulopathy and paroxysmal nocturnal hemoglobinuria. OMS906 is in Phase 2 clinical development and has not been approved by the FDA.
OMS906 targets MASP-3, a protein involved in the alternative complement pathway. By binding MASP-3, OMS906 is designed to inhibit activation of the alternative pathway, which is implicated in conditions such as C3 glomerulopathy and paroxysmal nocturnal hemoglobinuria.
OMS906 is being evaluated for the treatment of C3 glomerulopathy and paroxysmal nocturnal hemoglobinuria. Clinical trials have also enrolled patients with idiopathic immune complex-mediated glomerulonephritis. These are investigational uses, and OMS906 has not been approved for any indication.
OMS906 is developed by Omeros Corporation, which trades on the Nasdaq under the ticker OMER. Omeros is sponsoring the clinical trials evaluating OMS906 in complement-mediated kidney and blood disorders.
OMS906 is in Phase 2 clinical development. One Phase 2 trial in paroxysmal nocturnal hemoglobinuria is active but not recruiting, one Phase 2 trial in C3 glomerulopathy and immune complex-mediated glomerulonephritis is recruiting, and a Phase 2 PNH trial has completed. OMS906 is investigational and not FDA approved.
OMS906 has been studied in four registered trials. These include NCT06298955, a Phase 2 long-term PNH study; NCT06209736, a Phase 2 trial in C3G and ICGN; NCT05972967, a completed Phase 2 PNH trial in patients with a sub-optimal response to ravulizumab; and NCT05889299, a completed Phase 1 PNH study.
Yes. OMS906 study drug is another way of referring to OMS906, the investigational small molecule targeting MASP-3 that Omeros Corporation is developing for complement-mediated diseases including C3 glomerulopathy and paroxysmal nocturnal hemoglobinuria.