Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being developed for patients with End Stage Renal Disease Requiring Hemodialysis. It was studied in a Phase 2 clinical trial to evaluate its safety and how the body absorbs, distributes, and removes the drug, with a focus on reducing events such as heart attack and stroke in this patient population.
Fesomersen is a small molecule that targets Factor XI, a protein involved in blood clotting. By inhibiting Factor XI, the drug aims to reduce thrombotic events like heart attack and stroke while potentially preserving hemostasis. This mechanism was evaluated in a Phase 2 trial for patients with End Stage Renal Disease Requiring Hemodialysis.
Fesomersen is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The company conducted a Phase 2 clinical trial of Fesomersen in patients with End Stage Renal Disease Requiring Hemodialysis.
Fesomersen is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study involving 307 participants. The drug is still investigational and has not been approved by regulatory authorities for any indication.
Fesomersen has been studied in one completed Phase 2 clinical trial with the identifier NCT04534114. This trial enrolled 307 patients with End Stage Renal Disease Requiring Hemodialysis across multiple countries, including the United States, Belgium, Bulgaria, Canada, Czechia, Germany, Greece, Hungary, Japan, Latvia, Russia, South Korea, Spain, Taiwan, and Ukraine.
Yes, Fesomersen is also known as BAY2976217. In the clinical trial NCT04534114, the study drug is referred to as BAY2976217. This alternative name may appear in scientific literature and regulatory documents, so readers searching for either name will find information about the same investigational drug.