Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Human CD24, Human IgG Fc Fusion Protein, MK-7110, CD24 Fusion Protein
Efprezimod alfa · 2 trials · 4 indications
Time to improvement in COVID-19 clinical status: defined as time (days) required from start of treatment to improvement of clinical status severe - moderate/mild or improvement from score 2-4 to ≥5 sustained without drop below 5 within 28 days from randomization, total follow-up period 29 days (Randomization Day 1 + 28 days follow up) per National Institute of Allergy \& Infectious Diseases (NIAID) ordinal scale graded: 1=Death; 2=Hospitalized, on invasive mechanical ventilation (IMV)/extracorporeal membrane oxygenation (ECMO); 3=Hospitalized, on non-invasive ventilation (NIV)/high flow oxygen devices; 4=Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, don't require medical care; 7=Not hospitalized, limitation on activities \&/or require home oxygen; 8=Not hospitalized, no limitations on activities. Median time \& 95% confidence intervals (CIs) were reported using Brookmeyer-Crowley method.
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, only AEs with Common Terminology Criteria for AE (CTACAE) grade ≥3 were included. The number of participants who experienced an AE were reported.
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented. As described in the protocol, AEs reported after the protocol-specified timeframe were not analyzed in this outcome measure: 1 day prior to hematopoietic stem cell transplantation (HCT) through either 30 or 60 days post-HCT, depending on arm as defined in the Time Frame section.
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented.
A DLT was defined as: any Grade III or higher non-hematologic toxicity not clearly related to the underlying malignancy, intercurrent infection, or the hematopoietic stem cell transplantation conditioning regimen; any death not related to relapse or intercurrent infection; and failure to engraft by day 30. Event grading was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 criteria. Hypersensitivity reactions and other infusion-related reactions were not considered DLTs.
AGFS was defined as the time from the date of hematopoietic stem cell transplantation (HCT) to the earliest of Grade III-IV acute GVHD or death due to any cause, whichever occurred first. Event grading was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 criteria. Participants were censored at 181 days.
| Arm | Type | Description |
|---|---|---|
| Efprezimod alfa | EXPERIMENTAL | Participants receive single dose of 480 mg efprezimod alfa, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1. |
| Placebo | PLACEBO_COMPARATOR | Participants receive single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes, on Day 1. |
| Efprezimod alfa 240 mg | EXPERIMENTAL | Efprezimod alfa in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT) |
| Efprezimod alfa 480 mg | EXPERIMENTAL | Efprezimod alfa in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT) |
| Efprezimod alfa 960 mg | EXPERIMENTAL | Efprezimod alfa (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT) |
| Name | Type | Description |
|---|---|---|
| Efprezimod alfa | DRUG | Efprezimod alfa is given on Day 1. |
| Placebo | DRUG | Placebo is given on Day 1. |
| Methotrexate | DRUG | Acute GVHD prophylaxis |
| Tacrolimus | DRUG | Acute GVHD prophylaxis |
Inclusion Criteria: * Diagnosed with coronavirus disease 2019 (COVID-19) and confirmed severe acute respiratory syndrome coronavirus 2 (SARS-coV-2) viral infection * Severe or critical COVID-19, or National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal score 2, 3 or 4 (Scale ...
Efprezimod alfa is an investigational immunomodulator being developed by Merck & Company, Inc. (MRK) for Coronavirus Disease 2019 (COVID-19) and for prevention of acute graft versus host disease following allogeneic hematopoietic stem cell transplantation. It is a small molecule and is also known by the names CD24Fc and MK-7110.
Efprezimod alfa was studied as a non-antiviral immunomodulator for the treatment of Coronavirus Disease 2019 (COVID-19) in hospitalized adults. The Phase 3 trial NCT04317040 evaluated it in 234 participants in the United States. It is also being studied for prevention of acute graft versus host disease.
Efprezimod alfa is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program for the drug, including the Phase 3 COVID-19 study and the Phase 2 graft versus host disease study.
Efprezimod alfa has reached Phase 3 development. The Phase 3 trial NCT04317040 in Coronavirus Disease 2019 (COVID-19) is completed, and a Phase 2 trial in acute graft versus host disease prevention is also completed. The drug is investigational and is not approved by the FDA.
Efprezimod alfa has been studied in two completed trials. NCT04317040 was a Phase 3, randomized, double-blind, placebo-controlled study of 234 adults with Coronavirus Disease 2019 (COVID-19) in the United States. NCT02663622 was a Phase 2 study of 44 adults for prevention of acute graft versus host disease after myeloablative allogeneic hematopoietic stem cell transplantation.
Yes. Efprezimod alfa is also known as CD24Fc and MK-7110. These names refer to the same investigational small molecule developed by Merck & Company, Inc. (MRK), so search results using CD24Fc or MK-7110 describe the same drug asset and clinical program.