Positive topline phase II results for nipocalimab in pregnant individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN)
The Janssen Pharmaceutical Companies of Johnson & Johnson announced positive topline results from the proof-of-concept Phase II open-label UNITY clinical trial for the treatment of pregnant adults at high risk for severe hemolytic disease of the fetus and newborn (HDFN)
HDFN is a serious and rare condition which can cause life-threatening anemia in the fetus. It occurs when the blood types of a pregnant individual and their fetus are incompatible. The trial met the primary endpoint, with the majority of pregnant patients who received nipocalimab achieving a live birth at or after the gestational age (GA) of 32 weeks, without the need for an intrauterine transfusion (IUT) throughout their entire pregnancy. During the treatment period of approximately 20 weeks, nipocalimab demonstrated a safety profile that supports further development of the treatment in HDFN.
About UNITY: UNITY is a global, multicenter, open-label, non-blinded Phase II clinical trial to evaluate the safety and efficacy of nipocalimab for the treatment of pregnant adults at high risk for severe HDFN. In the trial, 14 participants received once weekly intravenous infusions. The primary endpoint was live birth at or after GA of 32 weeks, without a need for an intrauterine transfusion (IUT) throughout the entire pregnancy. Adverse events were monitored up to approximately 24 weeks post-delivery for parents and up to approximately 96 weeks post-birth for children.
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