Nipocalimab, a monoclonal antibody with a potential role in hemolytic disease of the fetus and newborn (HDFN) prevention, has shown promising results in a recently published study in Clinical Drug Investigation.
“Nipocalimab is currently under evaluation in multiple IgG autoantibody-mediated and alloantibody-mediated diseases in clinical trials globally, including sites in Japan,” the authors wrote.
In fetuses and newborns with HDFN, the antibody-mediated destruction of red blood cells (RBCs) leads to complications, including anemia, jaundice, and neurological damage (kernicterus).
The mother creates these deleterious antibodies in a process known as alloimmunization, where the maternal immune system recognizes the RBC antigen present in the fetus or in a blood transfusion as foreign.
Current therapies for HDFN consist of preventing alloimmunization or treating the complications of HDFN once they occur. Niopocalimab is an experimental therapy that binds to the neonatal antibody receptor, thus impairing the ability of alloantibodies to produce damage.
Learn more about HDFN therapies
As with every new drug, it is essential to determine how the body metabolizes and excretes the drug (pharmacokinetics) and what effects the drug causes in the body (pharmacodynamics).
The authors aimed to assess these parameters in a clinical trial that included 24 healthy volunteers. The volunteers were separated into four groups. The first group received nipocalimab at a 60 mg/kg dose; the second group received half the dose, the third group at 10 mg/kg and the third group received a placebo.
Researchers observed adverse effects in three patients, one from the 60 mg/kg group and two from the 30 mg/kg group. Two patients experienced dizziness, and one patient experienced flu-like symptoms.
Nipocalimab administration resulted in a significant reduction in IgG circulating antibodies; the findings speak in favor of the drug’s effectiveness.
“NIpocalimab administered at doses between 10 and 60 mg/kg by an IV infusion was generally safe and well tolerated compared to placebo without any new safety findings,” the authors wrote.
