Thursday, March 21, 2019 9:19:17 AM
Data supports M281’s potential to prevent placental transfer of disease-inducing antibodies from mother to fetus in alloimmune and autoimmune diseases of the fetus and newborn.
Excerpts:
Global multi-center Phase 2 study of M281 in hemolytic disease of the fetus and newborn (HDFN) now active following regulatory approvals.
This study in the gold standard model of the human term placenta showed that M281 has the potential to block the transfer of IgG from maternal to fetal circulation through late pregnancy.
Additionally, M281 itself showed insignificant transfer to the fetal circulation, which could minimize exposure of the fetus to M281. With lowering of systemic IgG, as seen in our Phase 1 study, and the potential to block placental transfer of pathogenic antibodies, we believe M281 has broad potential to treat alloimmune and autoimmune diseases of pregnancy, as well as a number of autoimmune diseases.
“We are also pleased to announce that we obtained appropriate regulatory approvals in the U.S., Canada, and several EU countries, and that clinical sites are in the process of being activated globally for our multicenter clinical trial evaluating M281 in the prevention of early antenatal hemolytic disease of the fetus and newborn, a disease with high fetal mortality and infant morbidity,” continued Dr. Arroyo.
Read more:
http://ir.momentapharma.com/news-releases/news-release-details/momenta-pharmaceuticals-announces-publication-new-data
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