RTI International Metals, Inc.

Low-Cost Antibiotic Could Prevent Sepsis in up to 2 Million Women Per Year Research Presented at the Society for Maternal-Fetal Medicine's 43rd Annual Pregnancy Meeting Study Made Possible through Partnership between the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the NICHD Global Network for Women's and Children's Health Research, the Bill & Melinda Gates Foundation and the Foundation for the National Institutes of Health NORTH BETHESDA, Md., Feb. 9, 2023 /PRNewswire/ -- The Foundation for the National Institutes of Health (FNIH) today announced that The New England Journal of Medicine (NEJM) has published the results of a study of antibiotic treatment to protect maternal health in resource-limited settings that could benefit up to 2 million women per year.1 The study, called the Azithromycin Prophylaxis in Labor Use Study (A-PLUS), found that one dose of azithromycin, a low-cost, generic, oral antibiotic, given during labor to women planning to deliver vaginally in low- and middle-income countries, can prevent life-threatening sepsis. "The A-PLUS study has remarkable potential to protect maternal health and represents a significant advancement, especially for women who cannot access modern obstetrical care," said Dr. Julie Gerberding, CEO of the Foundation for the National Institutes of Health (FNIH). "This multinational study is an exemplar of what can be accomplished through team science — connecting academic researchers around the world with NIH experts and private foundations, like the Bill & Melinda Gates Foundation, to advance global health breakthroughs. We thank the thousands of women and their care providers in seven countries who agreed to participate in the study even in the midst of a pandemic." Sepsis is a life-threatening condition caused by the body's extreme response to infection and can lead to organ failure and death. The World Health Organization (WHO) estimates sepsis due to obstetric infection is the third most common cause of maternal mortality globally.2 This randomized, placebo-controlled study found that a single dose of azithromycin reduces the occurrence of maternal sepsis by approximately 35%. When a combination of sepsis and death was analyzed, there was a 33% reduction. Given the nearly 6 million cases of maternal sepsis per year,3 the A-PLUS study results suggest that up to 2 million cases of maternal sepsis per year could be prevented with this readily available, affordable medicine. The study was designed to include 34,000 women in seven low- and middle-income countries who received a single dose of azithromycin or placebo during childbirth. However, an interim analysis found the treatment had a significant beneficial effect, and enrollment was halted early for maternal effectiveness after approximately 29,000 women were studied. "Sepsis is one of the leading causes of maternal death worldwide and there is urgent need for low-cost, effective interventions," said Prof. Dr. Antoinette Tshefu Kitoto, Professor of Public Health at Kinshasa School of Public Health and International Principal Investigator of the UNC-Democratic Republic of the Congo site. "We saw such a significant reduction in the incidence of sepsis with azithromycin that we stopped enrolling new participants early to ensure that as many women as possible could benefit from our findings as soon as possible." In addition to a reduction in sepsis, the study found a lower risk of maternal endometritis (uterine infection), hospital readmission and unscheduled medical visits among women who received azithromycin. Azithromycin is an inexpensive, generic antibiotic available in tablet form and suitable for room-temperature storage. The study included women at study sites located in Bangladesh, the Democratic Republic of Congo, Guatemala, India, Kenya, Pakistan, and Zambia. Consequently, the results are likely to be useful for informing national health policy and obstetrical practice in similar settings around the world. Investigators also examined the use of azithromycin to prevent sepsis or death in newborns. The intervention had no effect in this population. The drug also had no adverse newborn effects. In addition to publication in The New England Journal of Medicine, the study results were presented simultaneously at the Society for Maternal-Fetal Medicine's 43rd Annual Pregnancy Meeting in San Francisco, Calif. As a result of the study's positive findings, A-PLUS investigators will provide the World Health Organization (WHO) and other professional organizations with the results to inform their guidelines. This groundbreaking multi-site study was conducted by NICHD's Global Network for Women's and Children's Health Research and was co-funded by NICHD and the FNIH, with support to the FNIH provided by a grant from the Bill & Melinda Gates Foundation. Funding partners: Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of the National Institutes of Health Bill & Melinda Gates Foundation Implementing partners: RTI International Boston University in conjunction with Lata Medical Research Foundation (Nagpur, India) Columbia University in conjunction with Aga Khan University (Pakistan) Indiana University School of Medicine in conjunction with Moi University (Kenya) Thomas Jefferson University in conjunction with Jawaharlal Nehru Medical College (Belagavi, India) University of Alabama at Birmingham in conjunction with University of Zambia (Zambia) University of Colorado, Denver in conjunction with the Institute of Nutrition of Central America and Panama (Guatemala) University of North Carolina at Chapel Hill in conjunction with the Kinshasa School of Public Health (Democratic Republic of Congo) University of Virginia in conjunction with the International Center for Diarrheal Disease Research (Bangladesh) Additional information and a short video about the A-PLUS study are available on the FNIH website. About the A-PLUS Study: The Azithromycin Prophylaxis in Labor Use Study (A-PLUS) analyzed the safety and effectiveness of a single intrapartum oral dose of azithromycin compared to placebo, in reducing the risk of neonatal and maternal sepsis or death in laboring women. Single-dose azithromycin is a low-cost, accessible intervention, which was found to improve maternal health. The study was led by Drs. Alan T. N. Tita and Waldemar A. Carlo, from the University of Alabama at Birmingham, and Dr. Elizabeth M. McClure, of RTI International. It was conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Global Network for Women's and Children's Health Research. The study was funded by NICHD and through a grant from the Bill & Melinda Gates Foundation to the FNIH. About the Foundation for the National Institutes of Health: The Foundation for the National Institutes of Health (FNIH) connects the world's leading public and private organizations to accelerate biomedical breakthroughs for patients, regardless of who they are, where they live or what disease they have. Together with leading scientists and problem-solvers, and a successful track record of navigating complex problems, the FNIH accelerates new therapies, diagnostics, and potential cures; advances global health and equity in care; and celebrates and trains the next generation of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit fnih.org. Follow us on social media: LinkedIn, Twitter, Facebook Contact: Melanie Doupé Gaiser Ruder Finn, on behalf of FNIH 212.593.6459 [email protected] References: Tita A, Carlo W, McClure E, et al. Azithromycin to Prevent Sepsis or Death in Women Planning a Vaginal Birth. N Engl J Med. 2023;388:xxx-xxx. Maternal infections in Health Facilities. World Health Organization. . Published April 27, 2020. Accessed January 11, 2023. Rudd KE, Johnson SC, Agesa KM, et al. Global, Regional, and National Sepsis Incidence and Mortality, 1990-2017: Analysis for the Global Burden of Disease Study. The Lancet. 2020; 395(10219):200-211. SOURCE Foundation for the National Institutes of Health

SEATTLE--( BUSINESS WIRE )-- Audere , a digital health nonprofit developing solutions to advance health equity, today announced the appointment of Dr. Doris Macharia to its Board of Directors. Dr. Macharia is the Senior Vice President of Global Programs at Orbis International and brings extensive international global health expertise to Audere. Dr. Doris Macharia has more than twenty five years of experience in global health and development, spanning managerial, operational, and technical roles throughout the industry. She has experience managing country-specific and regional programming for HIV/AIDS, malaria, tuberculosis, COVID-19, family planning, social behavior change, and other key areas of focus for disease prevention and control. In her current role as the Senior Vice President of Global Programs at Orbis International, Dr. Macharia manages a portfolio of 70 projects in Africa, Asia, Latin America, and the Caribbeans and leads a global team to design, implement and manage eye health programs worldwide. Prior to her role with Orbis International, Dr Macharia held senior positions at FHI360, Futures Group, RTI International, UNICEF, ICAP Columbia University and US Centers for Disease Control and Prevention. Dr. Macharia is educated in the field, holding MBChB and MMed Internal Medicine degrees, a MSc in Epidemiology, and a postgraduate diploma in Health Economics. “As we continue to expand the implementation footprint and application of Audere’s cutting-edge HealthPulse technology, it is critical that we include board members with expansive experience across key global health diseases and geographies. Dr. Macharia’s unique perspective will enrich our leadership, and I am proud to welcome her to our Board of Directors!” - Dr. Dino Rech, CEO, Audere Dr. Macharia will join existing Audere board members Dr. Dino Rech, CEO of Audere; Dr. John Halamka, President of Mayo Clinic Platform; Lauren Lavoie, Director of Engineering, Health & Wellness Technology at Walmart; and Shyam Pather, CTO of Audere in guiding the strategic direction of the company. About Audere Audere is a global digital health nonprofit developing HealthPulse™ solutions to advance health equity in underserved communities worldwide. We operate at the unique intersection of global health and high tech, creating advanced, accessible software that revolutionizes the detection and treatment of diseases — such as malaria, COVID-19, and HIV. Our diverse team of passionate, innovative minds combines smartphone technology, artificial intelligence, and the best of cloud-based services to deliver HealthPulse™ solutions worldwide. Development of our projects is funded by grants and support from the Bill & Melinda Gates Foundation , FIND , and other global health partners. Learn more at auderenow.org .

Presentation at IPF Summit Elucidates APT-101 Mechanism of Action CARY, NC , Aug. 30, 2022 (GLOBE NEWSWIRE) -- APIE Therapeutics (APIE Tx), a preclinical pharmaceutical company pioneering novel and proprietary drugs to activate the apelin receptor (APJ), presented evidence that agonism of the apelinergic system (APJ/apelin axis) triggers the repair of damaged pulmonary vascular endothelial cells. Through this novel mechanism of action, APIE Tx’s lead experimental drug candidate, APT-101 may have therapeutic benefit in the treatment of fibrotic lung diseases caused by the breakdown of the vascular endothelial niche, an endothelial cell barrier that protects the alveoli and promotes oxygen exchange. APIE Tx is developing APT-101, a small molecule designed to bind selectively and preferentially to APJ, for the treatment of fibrotic diseases such as systemic sclerosis-associated lung disease (SSc-ILD) and idiopathic pulmonary fibrosis (IPF). APT-101 was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of IPF. “Since the discovery of apelin in 1998, interest in the apelinergic system and its role in the repair and maintenance of vascular health has increased dramatically, stated Esther M. Alegría, Ph.D., founder and CEO of APIE Therapeutics. “We are on the leading edge of drug discovery in this therapeutic area. Our small molecule candidate, APT-101 has shown the potential to protect the vascular endothelium from damage and also regenerate damaged lung tissue in animal models of pulmonary fibrosis. We are eager to advance APT-101 into the clinic where we can assess its therapeutic impact on patients living with pulmonary fibrosis such as interstitial lung disease (ILD).” The apelinergic system plays a key role in the maintenance of vascular health and function through regulation of fibrosis, cell proliferation and inflammation. Independent research shows that the apelin receptor, APJ is highly expressed in the pulmonary vascular endothelium and is upregulated in ILD in response to disease factors. Further, activation of the apelinergic system through APJ has been shown to regenerate the small capillary blood vessels that are damaged by inflammation and fibrosis, which are characteristic of ILD. These findings support the beneficial role of the apelinergic system in ILD and the development of an APJ agonist to activate these regenerative pathways. APT-101 is an orally bioavailable small molecule that selectively and potently targets APJ. In animal models of pulmonary fibrosis, APIE Tx has demonstrated that APT-101 diminishes the onset of fibrosis when administered before its onset and reduces collagen buildup and fibrosis when administered following pulmonary damage. The mechanism by which APT-101 exerts its therapeutic effect is through the normalization of key pathways involved in the health of vascular endothelial cells. Preclinical data presented at IPF Summit show that APT-101 normalizes the expression of endothelial nitric oxide synthase (eNOS), which is involved in maintenance of cell permeability and vascular function, and tissue metalloproteinase (TMP1), which is involved in regulation of fibrogenesis. Presentation Details: Poster Presentation: Repair and Regeneration of Vascular Endothelium as a Target for the Treatment of Lung Fibrosis Authors: Robert N. Willette, PhD; Scott Runyon, PhD; Ronnie Maitra, PhD; Esther Alegria, PhD Date/Time: August 30, 2022 at 3:30 pm ET The IPF Summit is a Hanson Wade conference taking place August 29-September 1, 2022 in Boston, MA. A copy of the poster may be found on the company website following the conclusion of the conference. About APIE Therapeutics APIE Therapeutics is a preclinical stage pharmaceutical company pioneering the development of a portfolio of small-molecule therapeutic drugs that target the apelinergic signaling pathway to repair and regenerate, post injury, the vasculature niche, which is associated with the pathophysiology of many chronic fibrotic diseases. APIE Therapeutics licensed a portfolio of compounds from RTI International, a well-known nonprofit research institute and inventors of commercial drugs such as Taxol®, Camptothecin®, EllaOne® and Esmya®. The company’s lead candidate, APT-101 was granted Orphan Drug Designation (ODD) by the U.S. FDA as a potential treatment of idiopathic pulmonary fibrosis (IPF). The company is on track to IND application with the U.S. FDA to commence a clinical program for the treatment of patients with systemic sclerosis (SSc), including those who have progressed to interstitial lung disease (SSc-ILD). Systemic sclerosis, sometimes referred to as systemic scleroderma, is a progressive systemic disease of unknown cause characterized by fibrotic scaring in major organ systems including the skin and kidneys. Patients often progress to develop ILD, which is the leading cause of early death for patients with SSc. Currently there are no disease modifying treatments for these patients, representing a critical unmet medical need for this orphan disorder. APIE Therapeutics Esther Alegria, Ph.D. info@apie-therapeutics.com