Nipocalimab, a investigational therapy currently in clinical development, has shown promising results and could prevent complications in pregnancies with hemolytic disease of the fetus and newborn (HDFN), according to a recently published study in Obstetrics and Gynecology.
HDFN is caused by antibodies transmitted from mother to fetus through the placenta that bind to and destroy red blood cells in the fetus, which in turn causes anemia and a yellowish coloration of the skin called jaundice. Nipocalimab is an investigational drug that targets the maternal antibodies that cause HDFN, blocking them and preventing their binding to fetal red blood cells.
The UNITY study is a clinical trial that included 14 pregnant patients with a history of HDFN diagnosed before the third trimester. Each of the included patients received a weekly dose of the investigational therapy starting at 14 weeks and ending at 35 weeks of gestation.
Read more about HDFN therapies and treatments
The researchers performed continuous tests to check for adverse effects and to assess the distribution and metabolism of the drug in the body. Regular blood tests to measure levels of HDFN-causing antibodies and the occupancy of the drug in the present antibodies were also performed.
Results showed that levels of HDFN-producing antibodies decreased by an average of about 80% just two weeks after beginning treatment. Antibody levels measured in the fetal cord were lower than those present in maternal blood samples.
In light of the results, the authors recommend performing a phase 3 study that will include more patients. The drug has not yet received approval from the U.S. Food and Drug Administration (FDA) to be distributed to the public as further clinical trials are needed to test its efficacy and safety.
“Nipocalimab demonstrates rapid and reversible FcRn occupancy, lowering of maternal IgG alloantibodies and evidence for decreased placental IgG alloantibody transfer. As a result, nipocalimab warrants further evaluation in a global phase III study in HDFN,” the authors concluded.
