Momenta Pharmaceuticals, Inc. (MNTA)

[floblu14]

Maternal-fetal medicine specialist first in US to lead clinical trial on life-threatening fetal blood disorder
UT HEALTH - 25 April 2019

Excerpts:

An investigational drug that may block harmful antibodies from passing through the placenta of an expectant mother to the fetus is the focus of a new clinical trial led by Kenneth Moise, MD, a maternal-fetal medicine specialist at The University of Texas Health Science Center at Houston (UTHealth).

McGovern Medical School at UTHealth is the first site in the U.S. to participate in this global clinical trial, which is focused on evaluating the safety and efficacy of the investigational drug M281 by Momenta Pharmaceuticals. Researchers will study whether the drug could eliminate the need for intrauterine transfusions (IUT) through the umbilical cord to fetuses who are at high risk for developing hemolytic disease of the fetus and newborn (HDFN), a rare and potentially life-threatening condition.

“I want to be among the last doctors to perform IUTs on unborn babies with blood incompatibility problems,” said Moise, who was honored with this year’s Society of Maternal Fetal Medicine’s Lifetime Achievement Award for more than three decades of work on HDFN and its most common form, Rh disease. “It’s time we stop putting moms through the stress of the procedure. Many complications, like infection, can arise anytime a needle is placed into a baby’s umbilical cord in the womb. In this study population of women with very severe HDFN, IUTs carry up to a 20 percent risk of fetal death, depending on stage of the pregnancy and experience of the center or clinic.”

M281 is an investigational monoclonal antibody engineered to block the neonatal Fc receptor (FcRn), a protein in the placenta that helps transport immunoglobulin G (IgG) antibodies from the mother to the fetus. The study drug is administered through a weekly intravenous infusion.

“The study drug was designed to inhibit the potentially harmful antibodies from passing through the placenta from early to late pregnancy, while also decreasing the amount of circulating antibodies in the mother,” Moise said. “This provides a two-pronged approach to lowering the amount of potentially dangerous antibodies from reaching the fetus. If successful, it will allow maternal-fetal specialists to replace a risky surgical treatment with a medical treatment that carries much less risk. This would enable women who thought they couldn’t have any more babies to consider growing their family. I am looking forward to investigating the capabilities of this investigational drug for women at risk of HDFN.”

Results from studies of placentas obtained from volunteers at the time of their delivery, recently published in the American Journal of Obstetrics & Gynecology, showed M281 significantly reduced the placental transfer of IgG, while only small amounts of the drug entered the fetal circulation.

Read full article:
https://www.uth.edu/news/story.htm?id=2a52b16f-5f73-4fb7-bbd1-9bfb2aa967ff