Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Narsoplimab
OMS721 · 2 trials · 2 indications
Percentage of patients alive at 100 days following the diagnosis of high-risk HSCT-TMA
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 |
|---|---|---|
| Narsoplimab single arm-treatment | EXPERIMENTAL | Narsoplimab 4 mg/kg |
| 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 |
|---|---|---|
| Biological: narsoplimab | DRUG | Treatment with narsoplimab 4 mg/kg will be administered |
| OMS721 | BIOLOGICAL | - |
Inclusion Criteria: 1. Age at least 28 days and less than 18 years prior to informed consent (Visit 0). 2. Have informed consent from at least one parent or legal guardian as required by local law and regulation. Patient informed consent will be required if the patient has reached the local legal a...
OMS721 is being developed for the treatment of thrombotic microangiopathies, a group of disorders involving blood vessel damage and abnormal clotting in small vessels. It is a monoclonal antibody in Phase 2 clinical development. Omeros Corporation is evaluating it in adult patients with these conditions.
OMS721 targets MASP-2, a protein involved in the lectin pathway of complement activation. By binding to MASP-2, the antibody is designed to inhibit complement-mediated damage. This mechanism is relevant to thrombotic microangiopathies, where complement dysregulation can contribute to disease.
OMS721 is being developed by Omeros Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol OMER. Omeros is responsible for the clinical development of the drug in thrombotic microangiopathies.
OMS721 is in Phase 2 clinical development. It has not been approved by the FDA for any indication. The Phase 2 trial in thrombotic microangiopathies has been completed, and the drug remains investigational.
OMS721 has been studied in a Phase 2 clinical trial, NCT02222545, titled "Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies." The trial enrolled 58 patients across multiple countries including the United States, Belgium, Italy, and others. It is listed as completed.