Johnson & Johnson Announces Positive Phase 2 Results for Nipocalimab in Hemolytic Disease of the Fetus and Newborn (HDFN)

Promising Results for New Treatment Option in Severe Cases

WEB SPRING HOUSE Pa. August 7, 2024

Johnson & Johnson today announced the positive results from the Phase 2 open-label UNITY study of nipocalimab, an investigational treatment for hemolytic disease of the fetus and newborn (HDFN).

HDFN is a serious condition that occurs when the mother's immune system produces antibodies that attack her unborn baby's red blood cells. This can lead to anemia, jaundice, and other life-threatening complications in the baby.

Nipocalimab is a human monoclonal antibody that blocks the neonatal Fc receptor (FcRn). FcRn is a protein that normally helps to protect IgG antibodies from degradation, allowing them to cross the placenta and provide immunity to the fetus. By blocking FcRn, nipocalimab inhibits the transplacental transfer of IgG antibodies, which can help to prevent HDFN.

The UNITY study was a Phase 2, open-label study that enrolled women with early-onset severe HDFN. The study evaluated the safety and efficacy of nipocalimab administered as a single dose during pregnancy. The primary endpoint of the study was the proportion of patients with a composite outcome of complete or partial response at Week 36 of gestation.

The results showed that 85% (11/13) of patients treated with nipocalimab achieved a complete or partial response at Week 36 of gestation, compared to 33% (4/12) of patients in the control group. The most common adverse events reported in the study were headache, injection site reactions, and fatigue.

"These results are very encouraging and suggest that nipocalimab has the potential to be a valuable new treatment option for women with severe HDFN," said Dr. William T. McAleer, Vice President of Medical Affairs for the Janssen Pharmaceutical Companies of Johnson & Johnson. "We look forward to continuing our research on nipocalimab in larger clinical trials."

Johnson & Johnson is committed to developing innovative therapies for the treatment of serious diseases. The company's commitment to maternal and child health is evident in its ongoing research and development programs in areas such as preeclampsia, preterm birth, and newborn care.