Janssen has announced positive results from the proof-of-concept Phase II UNITY trial for the treatment of pregnant individuals at high risk of early-onset severe (EOS) haemolytic disease of the foetus and newborn (HDFN).
A statistically significant (54%) proportion of participants who received nipocalimab achieved the primary endpoint of a live birth at or after gestational age of 32 weeks without intrauterine transfusions (IUTs).
This is compared to the historic reference point of 10%, which was derived from published and unpublished data. Among the seven participants who achieved the primary endpoint, the median gestational age at delivery was 37 and 1/7 weeks.
If approved, nipocalimab would be the first anti-neonatal Fc receptor (FcRn) treatment and the first approved non-surgical intervention for pregnancies at high risk of HDFN in the European Union.
Nipocalimab is currently the only therapy reported in clinical development for the treatment of alloimmunised pregnant individuals at high risk of severe HDFN, a serious and rare condition which occurs when the blood types of a pregnant individual and the foetus are incompatible, potentially causing life-threatening anaemia in the foetus or infant.
“Pregnancies affected by HDFN currently experience a high treatment burden, such as repeated, invasive IUTs that require access to specialty care and put the life of the foetus at risk,” said Kenneth Moise Jr, Professor, Department of Women’s Health and Director, Comprehensive Fetal Care Center, at Dell Medical School of the University of Texas at Austin and lead study investigator.
“I find these data encouraging, as they suggest the possibility of providing families with an effective, non-surgical HDFN treatment option if approved.”