SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) has announced encouraging results from the Phase 2 UNITY study evaluating nipocalimab for treating pregnant individuals at risk of early onset severe (EOS) Hemolytic Disease of the Fetus and Newborn (HDFN). The findings, published in The New England Journal of Medicine (NEJM), show that nipocalimab met its primary endpoint with 54% of participants achieving a live birth at or after 32 weeks gestational age without needing intrauterine transfusion (IUT).
HDFN is a severe condition that occurs when the blood types of a pregnant individual and the fetus are incompatible. This incompatibility can lead to life-threatening anemia in the fetus or infant. Nipocalimab is currently the only therapy in clinical development for this rare disease. The UNITY study results indicate that nipocalimab can delay or prevent severe fetal anemia and reduce the need for IUTs in high-risk pregnancies.
“The Phase 2 data published in the NEJM are encouraging, as the results support the potential of nipocalimab in the treatment of pregnant individuals with a history of severe HDFN,” said Dr. Kenneth J. Moise Jr., the lead study investigator and Professor at the University of Texas at Austin. “If approved, nipocalimab would be the first non-surgical treatment for pregnancies at high risk of HDFN.”
The UNITY study was a multicenter, open-label, single-arm Phase 2 trial. It assessed intravenous nipocalimab from 14 to 35 weeks in pregnancies at high risk for recurrent EOS HDFN. The study’s primary goal was to achieve a live birth at 32 weeks or later without requiring an IUT. The study succeeded, with 54% of the pregnancies meeting this criterion, compared to a 10% historical benchmark.
New data from the NEJM manuscript also compared outcomes of qualifying pregnancies and on-study pregnancies. The comparison revealed that the study had a higher proportion of live births (92% vs. 38%), fewer participants needing IUTs (85% vs. 46%), a later median gestational age at first IUT (27 weeks vs. 20 weeks), and a later median gestational age at delivery (36 weeks vs. 23 weeks). Additionally, no incidences of hydrops occurred in the study pregnancies, whereas seven participants had fetuses with hydrops in their most recent qualifying pregnancies.
In the study, the most frequently reported adverse events were consistent with those common in pregnancy and HDFN. Serious side effects also aligned with HDFN or other pregnancy-related conditions, including subchorionic hematoma and premature separation of the placenta. Infections and illnesses in infants of mothers exposed to nipocalimab were typical for the neonatal and infancy period. No maternal or neonatal/infant deaths occurred, although one pregnancy resulted in fetal demise related to an IUT complication.
“The UNITY study demonstrated positive efficacy and safety results, which support a favorable benefit-risk profile for nipocalimab,” the report stated. These results back further clinical development of nipocalimab. The AZALEA Phase 3 pivotal study is currently enrolling pregnant individuals at risk for severe HDFN to assess the efficacy and safety of the drug further.
Moreover, Johnson & Johnson is conducting a Phase 3 study of nipocalimab in fetal and neonatal alloimmune thrombocytopenia (FNAIT), a condition where the pregnant person’s immune system attacks fetal or newborn platelets, leading to thrombocytopenia and bleeding risks.
“We are committed to developing non-surgical options that are effective and have a proven safety profile for the treatment of alloantibody-driven maternal-fetal diseases,” said Dr. Katie Abouzahr, Vice President, Autoantibody Diseases and Maternal-Fetal Immunology Disease Area Leader at Johnson & Johnson Innovative Medicine. “The data published in the NEJM show the potential of nipocalimab to address the high unmet medical need in severe HDFN.”
The UNITY study results mark a significant step forward in addressing HDFN, potentially offering a safer and more effective treatment option for pregnant individuals and their developing fetuses. Johnson & Johnson remains committed to advancing this promising therapy through further clinical trials.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.