Morning Sickness

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

Researchers found only 19 trials for noninfectious chronic conditions, like depression and asthma, that included pregnant patients over the last 15 years.\n Pregnancy comes with unique health risks and considerations, but pregnant people also continue to experience the same health problems that nonpregnant people do. Despite this, a new study has found that fewer than 1% of randomized controlled trials in the U.S. include pregnant participants.The study was published in the American Journal of Obstetrics and Gynecology on Jan. 3 and was announced in a Jan. 21 press release.Out of 90,860 drug trials involving reproductive-age women from the last 15 years, only 0.8% included pregnant participants. What’s more, about 75% of the studies explicitly excluded pregnant people from participating.Excluding pregnant people from trials \"slows down the use of beneficial medications because doctors and pregnant people are hesitant to use drugs when there is limited safety data available,\" study author Alyssa Bilinski, Ph.D., a health policy researcher at Brown University, told Fierce Biotech in an email. \"Conversely, when a medication is harmful, more people likely experience adverse effects before the problem is discovered because not all individuals taking the medication are studied.\"Most of the trials that did include pregnant people were for pregnancy-specific conditions, like preventing preterm birth, preeclampsia and pregnancy-related symptoms like nausea.“We found only 19 trials for non-infectious chronic conditions like anxiety, depression and asthma that have included pregnant participants,” Bilinski said in the press release. Several tactics to increase pregnant patient participation in trials have been proposed by committees from the National Academies of Science, Engineering and Medicine and an FDA task force, Bilinski said. These include \"adjusting grant funding and timelines to account for challenges in working in this setting, improving communication to address liability concerns and changing classification of pregnant individuals as vulnerable in some review processes.\"In their paper, Bilinski and co-author Natalia Emanuel, Ph.D., an economist at the Federal Reserve Bank of New York, call for more randomized controlled trials that include pregnant patients. In the release, Bilinski pointed out that trials were only required to include women at all in 1993. “That really wasn’t that long ago,” Bilinski said. “Our hope is that 30 years from now, lacking high-quality evidence about medication safety during pregnancy will seem as strange and outdated as excluding women from trials seems to us today.”The two are now working on a paper about the health effects of excluding pregnant patients from trials, Bilinski said, using case studies like the COVID-19 vaccines and thalidomide, which was once used for treating morning sickness before it was discovered to cause serious birth defects.Editor\'s note: This story has been updated to include additional information from the study author.

A roundup of the most newsworthy healthcare press releases from PR Newswire this week, including a gene-edited pig kidney transplant, the world's first portable fentanyl detection device, and new research on social media and youth mental health. NEW YORK, Dec. 20, 2024 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Weekly Health Press Release Roundup, Dec. 16-20, 2024. Gene-Edited Pig Kidney Gives Living Donor New Lease on Life An Alabama woman is free from dialysis and in better health after surgeons at NYU Langone Health performed a gene-edited pig kidney transplant last month. The procedure marks the latest promising breakthrough in an emerging surgical practice posited as the solution to the organ supply crisis. Defense Diagnostics Launches DEFENT ONE All-In-One Fentanyl Detection Device With a rise in fentanyl poisonings in groups like high school students, college students, young professionals and everyday working-class citizens, DEFENT ONE intends to reduce overdoses by normalizing substance testing in all environments. Abbott Announces First-in-World Leadless Pacing Procedures in the Left Bundle Branch Area of the Heart These procedures mark the first time a leadless pacemaker has been implanted into the left bundle branch area, a key part of the heart's electrical conduction system, designed to mimic the heart's natural beat, offering people with slower-than-normal heart rhythms a new potential treatment option. Aetna Adds Spanish Language Capabilities for Health App to Better Serve Diverse Populations "As a proud Latino whose first language is Spanish, I'm thrilled to announce the new language capabilities on the Aetna Health app. Better health begins with better engagement with members, and these capabilities demonstrate our commitment to connecting every member to their care in the way that is most accessible for them," said Gus Giraldo, SVP, Individual & Family Plans, Aetna. Holiday Gifts That Help Build Speech and Language Skills in Young Children The American Speech-Language-Hearing Association (ASHA) shared some last-minute gift ideas for young children that can help encourage speech and language skills. Many of these gifts are low- to no-cost but offer rich learning opportunities. BD and Babson Diagnostics Launch Innovative Fingertip Blood Testing to Health Care Organizations With 70% of clinical decisions informed by diagnostic results, blood tests are a routine part of care to help clinicians diagnose, monitor and treat patients. This novel capillary solution enables care providers to improve access to blood testing in underserved locations that do not have phlebotomy capabilities, while lowering common barriers to testing such as fear of needles and logistical challenges. MHA Issues New Report on Social Media and Youth Mental Health "One thing has been notably absent from the public debate over social media's impact on youth mental health: feedback from young people themselves," said report co-author Tinuola Adebukola, MPH, CPH. "Any policy or technological solution must factor in the experiences of young social media users who have deep, unique insight into both the potential harms and benefits of these digital platforms." Scripta Insights Secures Series B Funding, Raises $42M Total, Revolutionizing the Way Americans Shop for Prescription Drugs "In the last year alone we've generated 78,000 prescription switches that have resulted in $29M in prescription savings. We're creating an America where access, affordability and adherence to necessary medicines are no longer barriers to positive health outcomes," said Eric Levin, CEO, Scripta Insights. The HER Foundation's Dr. Marlena Fejzo Spoke at the Inaugural White House Conference on Women's Health Research For over two decades, Fejzo has worked to advance hyperemesis gravidarum (HG) research, often without institutional funding. In 2017, she discovered GDF15 is the main cause of nausea and vomiting in pregnancy (NVP). Dr. Fejzo shared her personal journey at the White House, recounting the loss of her pregnancy in 1999 due to HG. Tackling the ACL Tear Epidemic in Youth Athletes: A Promising Solution from Arthrex Arthrex announced new research showing its cutting-edge ACL reconstruction (ACLR) using the InternalBrace™ technique offers an effective solution to combat reinjuries for young athletes. According to the National ACL Injury Coalition, ACL injuries among high school athletes have surged by nearly 26% over the past 15 years. American Cancer Fund Launches 12 Days of Giving Campaign to Support Cancer Patients and Recently Diagnosed Patients This Holiday Season The campaign invites supporters to contribute to the American Cancer Fund, enabling the fund to provide crucial assistance to cancer patients and their families. Each donation helps fund programs that offer sources for financial support, educational resources, and emotional encouragement to those affected by cancer. Samsung invests in Generate: Biomedicines to advance AI-driven protein therapeutics discovery Generate applies AI-based optimization and de novo generation to discover and design novel protein therapeutics, and has a robust pipeline of approximately 20 programs from preclinical to clinical development across oncology, immunology, and infectious diseases. For more news like this, check out all of the latest health-related releases from PR Newswire. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED