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The Janssen unit of Johnson & Johnson (NYSE:JNJ) announced Monday that its candidate for rare fetal disorder severe hemolytic disease of the fetus and newborn (HDFN) reached the main goal in a Phase 2 study.
A genetic condition, HDFN, can lead to anemia in newborns due to a mismatch between maternal and fetal blood types.
The open-label, non-blinded UNITY trial was designed to evaluate the monoclonal antibody nipocalimab in 14 pregnant adults at high risk for severe HDFN.
Citing topline data, Janssen said that UNITY reached the primary endpoint as mothers who received nipocalimab achieved a live birth at or after 32 weeks of pregnancy (gestational age) without requiring an intrauterine transfusion.
The company added that during ~20 weeks of treatment, nipocalimab indicated a favorable safety profile. After the birth, adverse events were monitored for up to ~24 weeks for parents and up to ~96 weeks for children.
The full results from UNITY are expected at a future medical meeting. Janssen has plans for a pivotal Phase 3 trial for nipocalimab.
Seeking Alpha contributor Dan Victor analyzed Johnson & Johnson (JNJ) after its Q4 2022 results recently, arguing that the JNJ is a “high-quality stock that maintains a positive long-term outlook beyond the near-term macro noise.”