- Johnson & Johnson’s Janssen unit on Monday said a drug it acquired two years ago showed promise in a mid-stage study of pregnant people at high risk of an ultra-rare condition known as severe hemolytic disease of the fetus and newborn.
- The life-threatening condition, known as HDFN for short, results from incompatible blood types between the pregnant person and the fetus. Antibodies from the pregnant person cross the placenta and destroy fetal red blood cells, causing anemia. It’s usually treated through intrauterine blood transfusions.
- In J&J’s small, open-label trial, an experimental drug called nipocalimab helped pregnant people achieve a live birth either at or after the gestational age of 32 weeks without a transfusion. The company did not disclose detailed data, which it said would be presented at an upcoming medical meeting. J&J is planning to follow up on the finding with a Phase 3 trial.
Nipocalimab came from the biotechnology company Momenta Pharmaceuticals, which pivoted from producing biosimilar copycats to developing its own drugs. The change in focus paid off in 2020, when J&J acquired the company for $6.5 billion.
The deal gave J&J access to nipocalimab, which targets an immune cell protein in order to shut down unwanted immune responses. It’s being studied for an array of conditions from maternal fetal diseases to rare autoantibody disorders and prevalent rheumatic conditions like arthritis and lupus.
One example highlighted at the time of J&J’s acquisition was myasthenia gravis, a condition also being targeted by Roche and Alexion Pharmaceuticals (now part of AstraZeneca).
In HDFN, nipocalimab gained a Fast Track designation from the Food and Drug Administration in 2019 and Orphan Drug status a year later.
"We look forward to sharing the full Phase 2 results of the UNITY trial at an upcoming scientific medical meeting while we continue to plan for a pivotal Phase 3 trial,” said Katie Abouzahr, autoantibody portfolio development leader at Janssen, in the company’s statement.
Fourteen participants received once weekly infusions of nipocalimab in the study, which assessed live birth at or after 32 weeks without the need for an intrauterine transfusion throughout the pregnancy. J&J said a “majority” of study participants met this goal.
No treatments are approved for HDFN and, according to J&J, nipocalimab is the only drug in clinical testing for “alloimmunized” pregnant adults at risk of severe HDFN.
Nipocalimab also continues to be studied in a range of other conditions such as Sjogren's syndrome and warm autoimmune hemolytic anemia.