Pre-Eclampsia

NIH findings may lead to insights on pregnancy complications, adult health BETHESDA, Md., May 2, 2025 /PRNewswire-HISPANIC PR WIRE/ -- What: The genes of male and female placentas have marked differences in how they are expressed, according to a study by researchers at the National Institutes of Health (NIH) and other institutions. These differences involve the presence or absence of tags on DNA known as methyl groups, which switch genes on or off without changing their structure. Understanding these DNA methylation patterns may inform future research on the higher risk for pregnancy complications involving male fetuses, such as stillbirth and prematurity, as well as later life health conditions that occur in adults who were born after a complicated pregnancy. Researchers analyzed male and female placental samples from a larger study for differences in their methylation patterns, and found differences in gene activity between male and female placentas that may play a role in birthweight and adult diseases. The study identified 2,497 previously unreported DNA sites that had different methylation patterns for males and females. Of these and more than 2,500 sites that had also been identified by previous studies, 66.9% of large increases in methylation occurred in DNA from male placentas and 33.1% from female placentas. Increases in methylation in male placentas was linked with greater neonatal size whereas those in females was linked with greater placental size. Some increases in methylation found in male placentas were located near the CCDC6 gene. Lower activation of CCDC6 has been linked with preterm birth in previous studies. Higher methylation near the FNDC5 gene was associated with lower expression of the gene in male placentas but not in female placentas. FNDC5 is involved with the manufacture of irisin, which protects the placenta from damage by reactive oxygen molecules and insulin resistance (cells' difficulty in using insulin to lower blood sugar.) Lower irisin levels have been associated with the pregnancy-related high blood pressure disorder, known as preeclampsia. Variations in the genes ATP5MG and FAM83A, expressed in female placentas, have been associated with asthma, hay fever, eczema (dry, itchy, inflamed skin) and higher risk for breast cancer later in life. Genetic factors influence the health differences between males and females, from before birth to later in life. Male fetuses grow faster than female fetuses and their pregnancies are more likely to be complicated by such conditions as preeclampsia (a hypertensive disorder of pregnancy), failure to grow at an adequate rate, and preterm birth. They also are more likely to die in the year after birth. Dysfunction of the placenta underlies many pregnancy complications and is thought to set the stage for male and female health differences that occur later in life. Variations in methylation patterns are thought to underlie many of these differences. The study was conducted by Fasil Tekola-Ayele, Ph.D., of the NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and colleagues at other institutions. It appears in Nature Communications. Who: Fasil Tekola-Ayele, Ph.D., is available for comment on this study. Reference Tekola-Ayele F, et al. Sex-differentiated placental methylation and gene expression regulation has implications for neonatal traits and adult diseases. Nature Communications. DOI: 10.1038/s41467-025-58128-3 (2025) SOURCE Eunice Kennedy Shriver National Institute of Child Health and Human Development; National Institutes of Health (NIH) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

EMA orphan drug designation is awarded to drugs intended to treat rare diseases that are life-threatening or chronically debilitating Preeclampsia, a serious obstetric complication, is a leading cause of near-term morbidity and mortality for mothers and their babies, and can lead to long-term consequences for both An investigational drug candidate, CBP-4888 leverages the precise targeting ability of siRNAs to downregulate sFlt1, a key pathogenic mediator of preeclampsia, in the placenta CBP-4888 represents the first potential molecularly targeted therapeutic for an obstetrical indication April 08, 2025 -- Comanche Biopharma Corp. today announced that the European Medicines Agency (EMA) has granted orphan drug designation for CBP-4888 for the treatment of sFlt1-mediated preterm preeclampsia. A serious obstetric complication, preeclampsia is estimated to impact approximately four in 10,000 pregnancies in the European Union each year. A novel siRNA drug candidate, CBP-4888 is designed to downregulate overexpression of the protein sFlt1, a known pathogenic mediator of preeclampsia, in the placenta. Currently an investigational drug candidate, CBP-4888 has the potential to be the first precision medicine for an obstetrical indication. “We are grateful to the EMA for granting orphan designation to CBP-4888 and recognizing preeclampsia as a life-threatening, significant unmet medical need,” said Allison August, M.D., Chief Medical Officer at Comanche Biopharma. “Beyond the acute morbidity and mortality risk that preeclampsia presents for mothers and their babies, it is also associated with serious, lifelong health complications. By targeting a root cause of preeclampsia with a precision medicine, our goal is to provide a therapeutic solution that can prevent the far-reaching, short- and long-term impact of this condition for mothers, babies, families and society at large.” The EMA grants orphan drug designation to drugs and biologics intended for the treatment, prevention or diagnosis of a life-threatening or chronically debilitating disease that affects fewer than five in 10,000 people in the European Union, and with either no currently approved method of diagnosis, prevention or treatment or with significant benefit to those affected by the disease. Sponsors who obtain orphan drug designation benefit from protocol assistance, market exclusivity and regulatory fee reductions. Overexpression of the protein sFlt1 is believed to be a key pathogenic mediator of preeclampsia. When produced in excess by the placenta, sFlt1 is toxic, severely damaging the mother’s blood vessels and impairing the growth of new ones. This overproduction of sFlt1 and subsequent vascular damage result in the common maternal signs and symptoms of preeclampsia and in fetal growth restriction. CBP-4888 is designed to achieve sufficient uptake by the placenta to selectively downregulate the disease-causing overexpression of the sFlt-1 protein in patients with sFlt-1-mediated preterm preeclampsia. CBP-4888 is being investigated for the potential to ameliorate the acute, potentially life-threatening maternal symptoms of preterm preeclampsia. This, in turn, may enable the safe prolongation of pregnancy and continued fetal maturation, thereby minimizing the near-term morbidity and mortality for mothers and their babies, and the potential long-term consequences for both. In addition to receiving Orphan Drug Designation by the EMA, CBP-4888 has also received Fast Track Designation by the U.S. Food and Drug Administration, and Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group. Preeclampsia is a serious pregnancy complication that affects up to 8% of pregnancies worldwide. It can lead to a range of acute, near-term complications for both mothers and their babies, including multi-organ damage, potential progression to eclampsia (onset of seizures) and premature births. Preeclampsia can also result in lifelong consequences, such as a higher risk of heart disease, chronic hypertension, cardiovascular disease and stroke for women, and learning disorders, cerebral palsy, epilepsy, blindness and deafness for infants born prematurely. Globally, there are an estimated 76,000 maternal deaths and 500,000 fetal and newborn deaths annually due to this complication of pregnancy. While preeclampsia can develop in any pregnancy, it disproportionately affects black individuals and those living in low resource settings. The signs and symptoms of preeclampsia can vary and include high blood pressure, acute kidney injury, swelling of the hands and face, severe headaches, vision changes and abdominal pain. Currently, premature delivery of the baby is the only available option for stopping the progression of preeclampsia. Comanche Biopharma is a clinical stage biopharmaceutical company working to make every pregnancy around the world safer by delivering innovative solutions and ensuring they are accessible to patients in need. We are currently developing CBP-4888, an innovative siRNA therapeutic candidate that, if approved, would be the world’s first treatment to target an underlying cause of preeclampsia, an obstetric complication globally responsible for a significant burden of maternal and infant morbidity and mortality, which can also lead to long-term consequences for both mothers and their babies. At Comanche, we are committed to the ethical representation of people of all colors and economic status globally in our clinical development programs. Visit us at comanchebiopharma.com. The content above comes from the network. if any infringement, please contact us to modify.

AdvaMed is again seeking a medical device exemption from the Trump Administration’s new import taxes, warning that the tariffs could cause supply chain disruptions that will increase prices, reduce access to treatment and force patients to wait longer for care. The medical device industry association and nine other health care groups wrote a letter to U.S. Trade Representative Jamieson Greer “in support of the administration’s focus to make America healthy again and to express our concern about the impact of tariffs on medical and dental supplies, equipment, and devices.” Previously: Manufacturers report price increases and other tariff troubles “These products are lifesaving, life-sustaining, and help deliver the timely care Americans need,” they continued. “… Given the important role of our work in making America healthy, we are concerned that tariffs placed on medical and dental equipment threaten to disrupt the supply chain and raise costs for these critical items. … We are also concerned that increased costs on medical and dental supplies could impede our ability to improve treatment outcomes, foster innovation, and meet the growing needs of pediatric and adult populations. This could result in longer wait times, reduced access to necessary treatments, and greater financial strain on health care systems that are already under pressure.” Led by AdvaMed, the signatories included the American Association for Homecare, American Dental Association, America’s Essential Hospitals, Association of American Medical Colleges (AAMC), Conquering CHD, Health Industry Distributors Association, Preeclampsia Foundation, Prevent Cancer, and Sepsis Alliance. The letter cited research showing 136 rural hospitals closed between 2010 and 2021 and that 700 more hospitals are at risk. They also cited a recent survey of healthcare supply chain professionals, pharmaceutical executives, distributors, and medical equipment manufacturers that found 80% expected increased import expenses would push costs up at least 15% for hospitals and health systems in the next few months. The results of that survey were released in February, weeks before the Trump Administration announced its unusually broad and steep tariff scheme. “We look forward to working with the Trump administration and other agencies to advance policies that improve the health outcomes of Americans,” the groups said. “We respectfully request that medical and dental supplies, equipment, and devices are made exempt from tariffs to prevent further escalation of health care costs and ensure patient accessibility to these products.” Medical device manufacturers — most recently including Steris — have said it’s too early to quantify how much these tariffs would hurt their businesses. It’s so far unclear exactly how they will apply and for how long, whether other nations will retaliate and how Trump will respond. Even if the devices themselves are exempted from import taxes, device manufacturers would likely still have to pay the tariffs on any materials or components they import to make their products. Shortly before AdvaMed publicly argued for an exemption in February, Intuitive Surgical warned Trump’s tariffs could hurt their business. November: Medtronic CEO Geoff Martha talks Trump import taxes and supply chain