Eclampsia

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.

THURSDAY, Dec. 26, 2024 -- Gestational hypertension, preeclampsia , and eclampsia are associated with an increased risk for neurological outcomes in the months or years after giving birth, according to a study published online Dec. 23 in JAMA Neurology . Therese Friis, M.D., from Uppsala University in Sweden, and colleagues examined whether gestational hypertension, preeclampsia, and eclampsia are associated with new-onset migraine, headache, epilepsy, sleep disorder, or mental fatigue within months to years after giving birth in a register-based cohort study. A total of 659,188 primiparous women with singleton pregnancies between 2005 and 2018 were identified through the Swedish Medical Birth Register; the final study population included 648,385 women. The researchers found that compared with women with normotensive pregnancies, women with gestational hypertension, preeclampsia, and eclampsia all had an association with an increased risk for a new-onset neurological disorder (adjusted hazard ratios, 1.27, 1.32, and 1.70, respectively). On examination of individual outcomes, the risk for epilepsy was increased more than fivefold for women with eclampsia (adjusted hazard ratio, 5.31). "Our findings warrant further investigations of neurological complications after gestational hypertension, preeclampsia, and eclampsia," the authors write. "They also highlight the need for follow-up regarding neurological disorders in women affected by these pregnancy complications." One author disclosed ties to the pharmaceutical industry.

Pylo 900-LTE blood pressure monitor is now clinically validated and FDA cleared for use during pregnancy, addressing the ongoing crisis of gestational hypertension. INDIANAPOLIS, Dec. 12, 2024 /PRNewswire/ -- Prevounce Health, a leading provider of remote care management software, devices, and services, announces exciting updates to its Pylo 900-LTE blood pressure monitor. The Pylo 900-LTE is now clinically validated and FDA cleared for use during pregnancy to remotely monitor for gestational hypertension, enabling the early detection of preeclampsia and the overall reduction of eclampsia in late pregnancy. Continue Reading Pylo 900-LTE Blood Pressure Monitor Hypertensive disorders during pregnancy (HDP) are a leading cause of fetal and maternal mortality. A recent review by the CDC found that 31% of maternal deaths during hospital delivery occurred on patients with an HPD. Remote patient monitoring (RPM) is an effective and feasible solution during pregnancy and has a demonstrated ability to improve blood pressure control in expecting mothers. With the pregnancy-validated Pylo 900-LTE and the Pylo GL1-LTE blood glucometer, as well as the Prevounce care management platform and full logistics services, Prevounce now offers the most complete solution for monitoring maternal health RPM programs. Remote maternal monitoring also provides significant cost savings to the healthcare system and patients. Hypertensive disorders are a leading cause of complications and pre-term births. With a recent study in California calculating the median cost of premature births of $296,974 per patient, reducing such complications with remote early detection corresponds to significant reductions in cost. For the reasons highlighted above, maternal health has received increased focus from policymakers, including the Centers for Medicare & Medicaid Services (CMS). "Clinicians and patients need new tools in the fight against fetal and maternal mortality," says Daniel Tashnek, founder and CEO of Prevounce. "Remote patient monitoring has proven to be an effective tool in managing both gestational hypertension and diabetes. We're hopeful our updated remote blood pressure monitor contributes in some small way to healthier mothers and safer pregnancies." Learn more about the Pylo 900-LTE and explore Prevounce's family of Pylo RPM devices, including blood pressure monitors, weight scales, blood glucose meters, and pulse oximeters. Each is clinically validated, comes with 5G/4G-LTE cellular connectivity, and seamlessly transmits readings to the Prevounce remote care platform or third-party platforms via API connectivity. About Prevounce Prevounce delivers comprehensive cloud software, cellular-connected devices, and expert services that help healthcare organizations simplify the provision of remote patient monitoring, chronic care management, preventive care, and annual wellness visits. Through its Pylo line of RPM devices, Prevounce offers blood pressure monitors, weight scales, blood glucose meters, and pulse oximeters. Devices connect natively with the Prevounce remote care management platform and integrate with other health software via the Pylo cloud API. Learn more about the Prevounce platform and Pylo devices at prevounce.com. Media Contact: Casey Johnson (818) 253-8755 [email protected] SOURCE Prevounce Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED