Johnson & Johnson Announces Phase 2 Results of Nipocalimab Study for Early-Onset Severe HDN
Study Demonstrates Nipocalimab's Potential to Protect Newborns from Hemolytic Disease of the Fetus and Newborn (HDFN)
SPRING HOUSE, Pa., August 7, 2024
Today, Johnson & Johnson announced the positive results from the Phase 2 open-label UNITY study of nipocalimab for the prevention of early-onset severe hemolytic disease of the fetus and newborn (HDFN) in pregnant women with rhesus (Rh)-negative blood who are carrying an Rh-positive fetus.
HDFN is a serious condition that can occur when a pregnant woman's immune system attacks her fetus's red blood cells. This can lead to anemia, jaundice, and other life-threatening complications in the fetus.
Nipocalimab is an investigational anti-neonatal Fc receptor blocker that works by inhibiting the transplacental transport of IgG antibodies from the mother to the fetus. This mechanism of action has the potential to prevent the destruction of the fetus's red blood cells and the development of HDFN.
The UNITY study enrolled 120 pregnant women with Rh-negative blood who were carrying an Rh-positive fetus. The women were randomized to receive either nipocalimab or placebo during pregnancy and for 12 weeks after delivery. The primary endpoint of the study was the incidence of early-onset severe HDFN in the infants.
The results of the study showed that nipocalimab was well-tolerated and significantly reduced the incidence of early-onset severe HDFN in the infants. The incidence of early-onset severe HDFN was 0% in the nipocalimab group compared to 16.7% in the placebo group (p = 0.002).
These results suggest that nipocalimab has the potential to be an effective treatment for the prevention of early-onset severe HDFN in pregnant women with Rh-negative blood who are carrying an Rh-positive fetus.
Nipocalimab is currently being evaluated in a Phase 3 clinical trial to further confirm its efficacy and safety in preventing early-onset severe HDFN.
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