2019 American Journal of obstetrics. AJOG.
Important study regarding M281, a monoclonal anti-FcRn antibody.
If the study eventually shows blocking of FcRn with Nipocalimab is a safe and effective way to manage HDFN, the same strategy could be applied to FNAIT. This once a week treatment was well tolerated in a Phase 1 study in healthy volunteers and was safe in pregnant animals. It is much easier on the mother than receiving IVIG once or twice a week with steroids.
Read about the M281 study here:
M281, an anti-FcRn antibody, inhibits IgG transfer in ahuman ex vivo placental perfusion model
Author and article information:
Momenta Pharmaceuticals, Cambridge, MA
Sucharita Roy, PhD; Tatiana Nanovskaya, PhD; Svetlana Patrikeeva, MS; Edward Cochran; Viraj Parge, MS;Jamey Guess, MS; John Schaeck, PhD; Amit Choudhury, PhD; Mahmoud Ahmed, PhD; Leona E. Ling, Ph
Why was this study conducted?
This study was conducted to evaluate the transplacental transfer of M281, a monoclonal anti-FcRn antibody and its potential to inhibit the transfer of immunoglobulin G from maternal to fetal circulation.
M281 significantly inhibits the maternal-to-fetal transfer of a representative immuoglobulin G molecule (adalimumab) in the ex vivo dually perfused human placental lobule model. However, M281 itself shows insignificant transfer from maternal to fetal circulation.
What does this add to what is known?
M281, a novel anti-FcRn antibody, may reduce the transfer of pathogenic immunoglobulin G from maternal to fetal circulation. These data support further investigation of M281 in the management of alloimmune or autoimmune diseases of the fetus and newborn.
The study is currently enrolling at sites around the world.
See the USA study here: clinicaltrials.gov NCT03842.
If the study eventually shows blocking of FcRn with Nipocalimab is a safe and effective way to manage HDFN, the same strategy could be applied to FNAIT.