Nipocalimab Study on High-Risk Pregnant Individuals Published in NEJM

Johnson & Johnson recently unveiled the results of their Phase 2 open-label UNITY study on nipocalimab, aimed at treating alloimmunized pregnant individuals at risk of early onset severe hemolytic disease of the fetus and newborn (EOS HDFN). The findings, published in The New England Journal of Medicine (NEJM), demonstrated that 54 percent of participants receiving nipocalimab achieved a live birth at or beyond 32 weeks of gestational age without needing intrauterine transfusion (IUT).

Nipocalimab is currently the only known therapy in clinical development for HDFN, a serious condition arising from blood type incompatibilities between a pregnant person and the fetus, which can lead to life-threatening anemia in the unborn child. The study's results indicated that nipocalimab delayed or prevented severe fetal anemia, thus reducing the necessity for IUTs in pregnancies with a high risk of recurrent EOS HDFN.

Dr. Kenneth J. Moise Jr., a lead investigator in the study and a professor at the University of Texas at Austin, expressed optimism about the Phase 2 data, noting it supports the potential of nipocalimab for treating individuals with a history of severe HDFN. He highlighted that severe HDFN has a poor prognosis and current treatments, which involve repeated IUTs, carry high risks. If approved, nipocalimab could become the first non-surgical treatment for high-risk pregnancies.

The UNITY study was a multicenter, single-arm trial that administered intravenous nipocalimab from 14-35 weeks of gestation to assess its efficacy and safety. The primary endpoint was a live birth at or beyond 32 weeks without needing an IUT. The results were promising, with 54 percent of pregnancies meeting the primary endpoint compared to a historical benchmark of 10 percent. Additionally, study pregnancies reported a higher proportion of live births, fewer required IUTs, and later median gestational ages at first IUT and delivery.

Safety monitoring in the study showed that the most frequently reported adverse events were consistent with those common in pregnancy and HDFN. Serious side effects included subchorionic hematoma and premature separation of the placenta, which are typical of HDFN or other pregnancy-related conditions. Importantly, there were no maternal or neonatal/infant deaths in the study, although one pregnancy did result in fetal demise due to a complication from an IUT.

The UNITY study's positive efficacy and safety outcomes suggest a favorable benefit-risk profile for nipocalimab, supporting its further clinical development for treating severe HDFN. Currently, the AZALEA Phase 3 pivotal study is enrolling individuals to further assess the safety and efficacy of nipocalimab in those with a history of severe HDFN.

Johnson & Johnson is also conducting a Phase 3 study on nipocalimab for fetal and neonatal alloimmune thrombocytopenia (FNAIT), a condition where the maternal immune system attacks fetal or newborn platelets, leading to thrombocytopenia and potential life-threatening bleeding. This underscores the company's commitment to developing non-surgical, effective treatments with proven safety profiles for alloantibody-driven maternal-fetal diseases.

Dr. Katie Abouzahr, Vice President at Johnson & Johnson, emphasized the company's dedication to addressing the unmet medical needs in severe HDFN through innovative and safe treatment options. The promising data from the UNITY study highlights nipocalimab's potential to make a significant impact on a condition where no other therapies are currently in clinical development.

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