Extremely low birth weight infant

SOUTH SAN FRANCISCO, CA, USA I February 24, 2025 I NGM Biopharmaceuticals, Inc. (NGM Bio), a privately held biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced that it has dosed the first participant in its EMERALD Phase 2 clinical study of NGM120, a GFRAL antagonist designed to block GDF15 activity, for the treatment of hyperemesis gravidarum (HG), a rare, debilitating condition of pregnancy. The leading cause of hospitalization in early pregnancy, HG is characterized by intractable nausea and vomiting, which can be as frequent as 10 to 15 times per day and results in dehydration, debility, weight loss and malnutrition. HG has a significant physical and psychosocial impact on patients and leads to overall higher rates of fetal loss and termination, preeclampsia, preterm birth, low birth weight, fetal malnutrition, maternal depression, and in some cases, suicidal thoughts. HG typically recurs in subsequent pregnancies. There are no approved therapies that target the underlying cause of HG. “We are proud to advance NGM120 into the clinic to evaluate its potential to address hyperemesis gravidarum, or HG, by targeting a major underlying cause of this debilitating condition,” said Wendy Yeh, M.D., Chief Medical Officer at NGM Bio. “Unfortunately, the severity and impact of HG are often underappreciated. At NGM, we understand how devastating this condition is, and we hear the pleas of women who experience the physical and mental toll of HG for an effective therapeutic solution. By inhibiting the activity of GDF15, NGM120 may potentially help reduce symptoms associated with HG, and, thereby, mitigate the impact and significant risks this condition can present during pregnancy.” Although GDF15 is a hormone that everyone produces, levels of GDF15 are higher in pregnant women and can be even higher in women with HG. The extremely high levels of GDF15 are believed to cause the nausea and vomiting that are hallmarks of HG. NGM120 is an antibody designed to bind to the receptor (known as GFRAL) for GDF15. This binding blocks the interaction of GDF15 with GFRAL, which, in turn, inhibits the activity of GDF15, potentially alleviating HG symptoms. NGM120 has been generally well-tolerated in over 140 non-pregnant participants treated in clinical trials to date. To learn more about NGM120 as a potential treatment for HG, link here . About the Randomized, Placebo-Controlled EMERALD Phase 2 Study The randomized, placebo-controlled EMERALD study is designed to assess the safety and tolerability of NGM120 in addition to standard of care and supportive care. Eligible pregnant participants diagnosed with HG who are enrolled in the study will receive a single subcutaneous dose of NGM120 or placebo on the first day of the assigned study period, which lasts seven days. Participants assigned to the NGM120 arm and participants assigned to the placebo arm will also receive the following: intravenous (IV) fluids with multivitamins on several days prior to and throughout the seven-day study period as supportive care; IV multivitamins according to the standard of care at each study center; and 4 mg ondansetron (a prescription medicine that counteracts nausea and vomiting) three times daily, per standard of care. The EMERALD study is enrolling participants in the United Kingdom ( ISRCTN76681798 ) and Australia (ACTRN12624001421527). To learn more, please visit the following clinical trial listings: United Kingdom (Link here ) Australia (Link here ) About NGM Bio NGM Biopharmaceuticals, Inc. (NGM Bio), a wholly owned subsidiary of NGM Bio Holdings, Inc., a privately held biotechnology company, is focused on discovering and developing novel, life-changing medicines for people whose health and lives have been disrupted by disease. NGM Bio’s biology-centric drug discovery approach aims to seamlessly integrate interrogation of complex disease-associated biology and protein engineering expertise to unlock proprietary insights that are leveraged to generate promising product candidates, enable their rapid advancement into proof-of-concept studies and address high unmet patient need. NGM Bio has three clinical-stage programs: NGM120, a GFRAL antagonist designed to block the activity of GDF15, in development for hyperemesis gravidarum and for cancer cachexia, and aldafermin, an engineered analog of the human hormone FGF19, in development for primary sclerosing cholangitis. Visit us at http://www.ngmbio.com for more information. Abbreviations FGF19 = fibroblast growth factor 19; GDF15 = growth differentiation factor 15; GFRAL = glial cell-derived neurotrophic factor receptor alpha-like SOURCE: NGM Bio

Identifying patients at high risk of developing severe preeclampsia can lead to better prediction, earlier interventions and reduced adverse outcomes.1 In the United States, preeclampsia has increased 25% in the last two decades and is a leading cause of maternal and infant illness and death,2 disproportionately affecting Black women.3 With an extensive U.S. installation base of more than 4,000 cobas® analyzers and a high degree of menu consolidation across various indications, clinicians are supported in making faster, more efficient clinical decisions. INDIANAPOLIS, Feb. 13, 2025 /PRNewswire/ -- Roche announced today that the Roche Elecsys® sFlt-1/PlGF ratio for preeclampsia has received 510(k) clearance from the United States Food and Drug Administration (FDA). The ratio is a prognostic test intended to stratify hospitalized pregnant women with hypertensive disorders of pregnancy into low- and high-risk categories for developing severe preeclampsia within two weeks of testing. Identifying patients at high risk for severe preeclampsia can lead to better prediction, earlier interventions and reduced adverse outcomes.1 In the U.S., preeclampsia has increased 25% in the last two decades and is a leading cause of maternal and fetal illness and death.2 Black women in particular experience higher rates of maternal and adverse fetal and neonatal outcomes than other racial and ethnic groups and are at greater risk for developing hypertensive disorders of pregnancy than other pregnant women.3 "There is a great need for highly reliable tools, such as the Elecsys sFlt-1/PlGF ratio, to address severe preeclampsia," said Brad Moore, president and CEO of Roche Diagnostics North America. "We are eager to partner with our customers so this prognostic test can help clinicians plan care and improve patient outcomes." sFlt-1 and PlGF are key biomarkers in the formation of blood vessels during pregnancy. However, an angiogenic imbalance of these key biomarkers has been proven to play an important role in the development of preeclampsia. Their concentrations in maternal serum are altered even before the onset of the disease, making them a valuable tool for predicting preeclampsia progression.4,5 Nearly 70% of women with a sFlt-1/PlGF ratio greater than 38 delivered their babies within two weeks.1 "The current clinical diagnostic criteria are poor in predicting, with accuracy, the development of preeclampsia among patients with hypertensive disorders of pregnancy," said Sarosh Rana, M.D., MPH, FACOG, University of Chicago Medicine. "The clearance of this ratio provides clinicians with an additional tool to predict the risk of severe preeclampsia and support clinical management by increasing surveillance in high-risk patients or prolonging pregnancy in low-risk patients, ultimately preventing adverse maternal, fetal and neonatal outcomes." Preeclampsia is defined as the new onset of hypertension and proteinuria after 20 weeks of gestation, or in the absence of proteinuria, new-onset hypertension and any of the following: thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or new onset of headache unresponsive to medication.6 Preeclampsia can be treated only by removal of the placenta at delivery.6 The clinical presentation of preeclampsia and the subsequent clinical course of the disorder can vary tremendously, making prediction, diagnosis and assessment of progression difficult.6 "The FDA clearance of the sFlt-1/PlGF ratio on Roche platforms is a major milestone in the quest to solve preeclampsia," said Ravi Thadhani, M.D., MPH, executive vice president of Health Affairs at Emory University. "This test will give clinicians an additional tool to stratify women at highest risk for the development of severe preeclampsia. Preeclampsia biomarker testing has the potential to spur innovation in new therapies that are sorely needed for these patients." Preeclampsia and its symptoms, such as headaches, visual changes, epigastric pain, and shortness of breath,6 have warning signs that are often overlooked and have devastating and lasting impact on mothers and babies if not properly managed.7 Impacts can include maternal organ damage and an increased risk of future heart failure, preterm birth6 and avoidable mental trauma.8 Hospitalization is typically recommended to evaluate the potential for progression to severe disease. Standard diagnostic markers for preeclampsia are often nonspecific and may not accurately predict the severity of the condition or associated adverse outcomes in the subsequent days and weeks.7 The preeclampsia ratio aligns with Roche's commitment to lead with science in order to develop transformational solutions that improve patient outcomes and simplify lab operations. Roche provides an unrivaled ability to scale access to testing at speed for those who need it most. With an extensive U.S. installation base of more than 4,000 cobas® analyzers and a high degree of menu consolidation across various indications, clinicians are supported in making faster, more efficient clinical decisions, providing the ability to scale testing at speed for even more women. About Preeclampsia Preeclampsia is a serious multi-system complication of pregnancy, occurring in 3% to 4% of pregnancies in the U.S., and remains one of the leading causes of maternal and perinatal morbidity and mortality worldwide.7 Preeclampsia can also have negative effects on the fetus and newborn, resulting in complications such as intrauterine growth restriction, low birth weight and stillbirth. These complications often necessitate early induction of labor or cesarean delivery, leading to preterm birth.9 Each year in the U.S., there are 4 million pregnancies, of which 120,000 to 160,000 are affected by preeclampsia. From 2017-2019, hypertensive disorders of pregnancy – including gestational hypertension, chronic hypertension, preeclampsia and superimposed preeclampsia – accounted for 6.3% of pregnancy-related deaths in the U.S.10 In 2022, there were approximately 22 maternal deaths for every 100,000 live births in the U.S. – far above that of other high-income countries.11 About Elecsys sFlt-1/PlGF Ratio The Elecsys sFlt-1/PlGF ratio for preeclampsia is an FDA-cleared test to clinically assess the progression of preeclampsia.12 The preeclampsia ratio supports the management of pregnant patients with a singleton pregnancy, and is intended to help clinicians stratify hospitalized patients into low- and high-risk categories for developing severe preeclampsia within two weeks of presentation.12 Identification of high-risk preeclampsia patients can lead to better prediction, earlier interventions and reduced adverse outcomes.1,5,13 The Elecsys sFlt-1 and Elecsys PlGF assays are provided in separate kits. The ratio must be calculated using Elecsys sFlt 1 and Elecsys PlGF results obtained on the same patient sample and the same cobas immunoassay analyzer per the intended use. The assay results should be used only in conjunction with information available from clinical evaluations and other standard-of-care procedures. The test result is not to be used to replace clinical judgment. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References 1. Berg A, Bautista M, Guo G, et al. Circulating angiogenic factors for stratifying the risk of preeclampsia with severe features. SMFM Global Meeting 2024. Pregnancy 2025. 2. Cameron, et al. Trends in the incidence of new-onset hypertensive disorders of pregnancy among rural and urban areas in the United States, 2007 to 2019. J Am Heart Assoc. 2022;11:e023791. 3. Davis NL, Smoots AN, Goodman DA. Pregnancy-Related Deaths: Data from 14 U.S. Maternal Mortality Review Committees, 2008-2017. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services;2019. 4. Levine RJ, et al. Circulating angiogenic factors and the risk of preeclampsia. N Engl J Med 2004;350:672–83. 5. Zeisler H, et al. Predictive value of the sFlt-1:PlGF ratio in women with suspected preeclampsia. N Engl J Med 2016;374:13–22. 6. Gestational hypertension and preeclampsia. ACOG Practice Bulletin No. 222. American College of Obstetricians and Gynecologists. Obstet Gynecol 2020;135:e237–60. 7. Burwick RM, Rodriguez MH. Angiogenic Biomarkers in Preeclampsia. Obstet Gynecol. 2024;143(4):515-523. 8. Not Just Physical: The Psychological Burden Of Preeclampsia And HELLP Syndrome. 9. Backes CH, et al. Maternal Preeclampsia and Neonatal Outcomes. J Pregnancy. 2011;214365. 10. Pregnancy Mortality Surveillance System. 11. Hoyert DL. Maternal mortality rates in the United States, 2022. NCHS Health E-Stats. 2024. 12. Method Sheet Elecsys sFlt-1/PlGF ratio for preeclampsia. 2025 v 1.0. English. 13. Thadhani, et al. Circulating angiogenic factor levels in hypertensive disorders of pregnancy. NEJM Evid 2022;1:(12). For Further Information Roche Diagnostics U.S. Media Relations [email protected] Jennifer Hoopingarner 1-317-797-9741 [email protected] Gina Goodenough 1-317-734-7171 [email protected] SOURCE Roche Diagnostics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

THURSDAY, Dec. 19, 2024 -- After years of decline, U.S. life expectancy is finally on the rise again for the first time since 2019, new government research shows. This turnaround was driven in part by a decline in drug overdose deaths, which had risen dramatically as a result of the opioid epidemic, according to a second report from the U.S. Centers for Disease Control and Prevention. That includes the first reduction in OD deaths caused by powerful synthetic opioids like fentanyl and tramadol, researchers said. “The age-adjusted rate for drug overdose deaths involving synthetic opioids other than methadone decreased from 2022 to 2023, the first such decrease since the large increases that began in 2013,” concluded the research team led by Matthew Garnett , an injury epidemiologist and statistician with the CDC’s National Center for Health Statistics (NCHS). “The rate also decreased for deaths involving natural and semisynthetic opioids and heroin between 2022 and 2023,” the team added. Life expectancy at birth in 2023 was 78.4 years for the total population, an increase of 0.9 years from 77.5 in 2022, CDC researchers reported. For men, life expectancy increased 1 year, from 74.8 in 2022 to 75.8 in 2023. Meanwhile, women saw a 0.9-year increase, from 80.2 in 2022 to 81.1 in 2023. “From 2022 to 2023, age-adjusted death rates decreased for 9 of the 10 leading causes of death,” wrote the life expectancy research team led by Elizabeth Arias , a health scientist with the NCHS. Deaths due to heart disease, accidental injury, stroke, respiratory disease, Alzheimer’s disease, diabetes, kidney disease, liver disease and COVID-19 all fell significantly between 2022 and 2023, researchers found. The rate of cancer deaths also went down, but not significantly, the report says. The end of the pandemic likely contributed to the increase in life expectancy, researchers said. “The most notable change was for COVID-19, which dropped from the 4th leading cause in 2022 to the 10th leading cause in 2023,” the researchers wrote. Overall, COVID deaths decreased more than 73% between 2022 and 2023, falling from 44.5 deaths to 11.9 deaths per 100,000, researchers said. A decrease in drug OD deaths also contributed to improved life expectancy. The rate of drug overdose deaths fell from 32.6 per 100,000 in 2022 to 31.3 per 100,000 in 2023, researchers said. Drug OD deaths are considered accidental injury deaths. These results jibe with statistics released last week by the CDC, which reported that drug OD deaths had decreased 17% between July 2023 and July 2024. However, the OD death rate is still 3.5 times what it was in 2003, when 8.9 people for every 100,000 died by drug overdose. Drug OD deaths related to synthetic opioids declined by 2.2% between 2022 and 2023, results show -- the first significant decline in OD deaths related to synthetic opioids like fentanyl since 2003, researchers added. Drug overdose deaths related to natural opioids like morphine, oxycodone and hydrocodone also declined 17.1%, between 2022 and 2023, and OD deaths caused by heroin decreased 33.3%. However, OD death rates for cocaine increased by 4.9% between 2022 and 2023, and OD deaths from stimulants like methamphetamine increased by 1.9%, researchers said. Lastly, infants did not seem to benefit from the declining death rates, researchers found. “The infant mortality rate of 560.2 infant deaths per 100,000 live births in 2023 was not significantly different from the rate in 2022,” the researchers wrote. The ten leading causes of infant death in 2023 -- birth defects, low birth weight, sudden infant death syndrome, unintentional injuries, maternal complications, bacterial sepsis of newborn, cord and placental complications, respiratory distress of newborn, intrauterine hypoxia and birth asphyxia, and diseases of the circulatory system -- accounted for more than 65% of all infant deaths, researchers concluded. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.