The proof-of-concept trial showed that 54% of participants treated with nipocalimab met the primary endpoint of live birth at or after the gestational age of 32 weeks without intrauterine transfusions
Janssen’s nipocalimab yields positive results in the UNITY study. (Credit: Omar Lopez on Unsplash)
The Janssen Pharmaceutical Companies of Johnson & Johnson (J&J) announced that data from the Phase 2 UNITY clinical trial has shown potential benefit of Nipocalimab for pregnant individuals who are highly prone to early-onset severe (EOS) haemolytic disease of the foetus and newborn (HDFN).
Nipocalimab is an investigational, high-affinity, fully human, aglycosylated, effectorless, monoclonal antibody. It has been engineered to selectively block the anti-neonatal Fc receptor (FcRn) to reduce levels of circulating IgG antibodies.
The positive results from the proof-of-concept trial showed that 54% of the 13 participants treated with nipocalimab met the primary endpoint of live birth at or after the gestational age of 32 weeks without intrauterine transfusions (IUTs).
The findings were compared against the historic reference point of 10%, which was taken from published and unpublished data.
Janssen said that the median gestational age at delivery among the seven patients who met the primary endpoint was 37 and 1/7 weeks.
Upon regulatory approval, Nipocalimab will become the first anti-neonatal Fc receptor (FcRn) medication approved in the US as well as the first non-surgical option for pregnancies with a high risk of HDFN.
Janssen research and development autoantibody portfolio and maternal fetal disease area leader VP Katie Abouzahr said: “There is a significant unmet need to help address the serious and life-threatening health consequences of HDFN. Our aspiration is to transform the existing paradigm for families who endure the consequences of HDFN by seeking approval of a targeted and effective therapy.
“These Phase 2 UNITY data in high-risk pregnancies demonstrated the important role that nipocalimab, an FcRn blocking antibody, may play in preventing the transfer of maternal alloantibodies through the placenta, thereby offering a potential treatment option for this devastating disease.”
UNITY is a global, multicentre, open-label, non-blinded clinical trial designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of nipocalimab.
It enrolled RhD (D) or Kell (K) alloimmunised pregnant individuals with singleton pregnancies at high risk for EOS HDFN.
Nipocalimab received fast track designation in July 2019 and orphan drug status in June 2020 from the US Food and Drug Administration (FDA).
In 2020, J&J gained the rights to nipocalimab through the $6.5bn acquisition of Momenta Pharmaceuticals.