Janssen’s study for nipocalimab as indicated for EOS-HDFN published in The New England Journal of Medicine
Natalia Elliot | August 9, 2024 | News story | Research and Development | Haematology, Janssen, New England Journal of Medicine, Obstetrics & Gynaecology, foetus, newborn, women's health
Johnson & Johnson company Janssen has announced that the results from its phase 2 trial into nipocalimab have been published in The New England Journal of Medicine (NEJM).
UNITY was a multicentre, open-label, single-arm phase 2 trial which assessed intravenous nipocalimab from 14-35 gestational age (GA) weeks in pregnancies at high risk of recurrent early-onset severe haemolytic disease of the foetus and newborn (EOS-HDFN). The disease is a rare condition resulting from the pregnant individual and foetus’s blood types being incompatible. This can result in life-threatening anaemia in the foetus or infant.
The study met its primary endpoint, with 54% of individuals receiving nipocalimab achieving a live birth at or after 32 weeks GA without the need for intrauterine transfusion (IUT).
“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, helping to establish a path forward for further development in this disease in a larger scale phase 3 study,” said Kenneth J Moise Jr MD, professor at the Department of Women’s Health, co-director of Comprehensive Fetal Care Center at Dell Medical School of the University of Texas at Austin, US, and lead study investigator. “For many patients, severe HDFN has a poor prognosis, and the current standard of care carries with it a high treatment burden, such as repeated IUTs and additional in-utero procedures that require access to specialty care and carry a risk to the life of the foetus. If approved, nipocalimab would be the first non-surgical treatment for pregnancies at high risk of HDFN.”
James Spargo
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