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Also known as Fesomersen sodium (BAY2976217), Factor XI LICA
Fesomersen · 1 trial · 1 indication
MB is defined as symptomatic bleeding and: 1) Fatal bleeding, and/or; 2) Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or; 3) Bleeding causing a fall in hemoglobin level of 20 g/L (2.0 g/dL) (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. CRNMB is defined as any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: 1) Requiring medical intervention by a healthcare professional; 2) Leading to hospitalization or increased level of care; 3) Prompting a face-to-face evaluation. n/100 person-years: number of subjects with incident events divided by the cumulative at-risk time in the reference population, where a subject is no longer at risk once an incident event occurred.
| Arm | Type | Description |
|---|---|---|
| Pooled Placebo | PLACEBO_COMPARATOR | Participants received subcutaneous treatment with matching placebo. |
| 40 mg BAY2976217 | EXPERIMENTAL | Participants received subcutaneous treatment with 40 mg BAY2976217. |
| 80 mg BAY2976217 | EXPERIMENTAL | Participants received subcutaneous treatment with 80 mg BAY2976217. |
| 120 mg BAY2976217 | EXPERIMENTAL | Participants received subcutaneous treatment with 120 mg BAY2976217. |
| Name | Type | Description |
|---|---|---|
| Fesomersen sodium (BAY2976217) | DRUG | Study intervention will be injected subcutaneously. |
| Placebo | DRUG | Matching placebo to BAY2976217 will be injected subcutaneously. |
Inclusion Criteria: * Participant must be at least 18 years of age at the time of signing the informed consent form (ICF) * Participants with ESRD on hemodialysis (HD) for ≥3 months at the time of signing of the ICF, receiving dialysis at least 9 hours a week and stable in the view of the investiga...
Fesomersen is being developed for people with end stage renal disease who require hemodialysis. It is an investigational RNA therapy studied in this patient population, with the goal of reducing the risk of events such as heart attack and stroke. It is not approved for use.
Fesomersen is an antisense oligonucleotide, an RNA therapy that targets factor XI. By reducing factor XI, a protein involved in blood clotting, the drug is designed to lower clot formation. Its development focuses on reducing thrombotic events such as heart attack and stroke in patients on hemodialysis.
Fesomersen is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the clinical program evaluating the drug in patients with end stage renal disease requiring hemodialysis.
Fesomersen is in Phase 2 development. It is an investigational drug and has not been approved by the FDA. The Phase 2 trial in patients with end stage renal disease requiring hemodialysis has been completed.
Fesomersen has been studied in one completed Phase 2 trial, NCT04534114. That randomized, double-blind, placebo-controlled study enrolled 307 patients with end stage renal disease requiring hemodialysis across the United States, Europe, and Asia, and assessed safety along with how the body absorbs, distributes, and removes the drug.
Yes. Fesomersen is also known as fesomersen sodium, or BAY2976217, Bayer's internal compound code. Both names refer to the same investigational antisense RNA therapy targeting factor XI.