In the United States, one in ten babies is born prematurely. The earlier in pregnancy a baby is born, the more likely s/he will have an extended hospital stay, as well as serious health complications such as respiratory distress syndrome, necrotizing enterocolitis, vision problems and infection. Women who have had a previous premature birth and women diagnosed with a short cervix in mid pregnancy are at high risk for preterm birth, and are typically prescribed a progesterone product to reduce this risk. There are currently only two general progesterone products available to women at risk for pre-term birth, each having drawbacks associated with variable efficacy and ease of use. Moreover, none of the available progesterone products have received approval from the Federal Drug Administration for use in pregnant women diagnosed with a short cervix. To improve treatment options for women having one or both clinical risk factors for a preterm birth, Daré Bioscience is advancing the development of a novel intravaginal ring, called DARE-FRT1. DARE-FRT1 offers women a patient-friendly, extended-release progesterone product that delivers a relatively constant level of the drug in close proximity to the cervix, where progesterone action regulates inflammation, contractility, and other activities associated with labor. An in vivo preclinical study demonstrated that DARE-FRT1 slowly releases bioidentical progesterone over at least 14 days. Building on these strong foundational studies we aim to (i) complete IND- enabling in vitro DARE-FRT1 product stability studies to ensure consistent and product and (ii) evaluate the comparative pharmacokinetics of different DARE-FRT1 doses in a first-in-human clinical study. Thus, DARE- FRT1 holds promise to be the first simple, safe, and convenient method to extend the term of gestation in women at high risk for preterm birth, improving overall health outcomes, and reducing infant mortality.
Public Health Relevance Statement: Infants that are born prematurely, before 37 weeks of pregnancy, are likely to have more health problems than those carried to term, including serious problems that affect the brain, lungs, vision, and hearing. Progesterone is a natural hormone that is involved in maintaining healthy pregnancies, and progesterone supplementation is the gold standard of treatment for women who are at high risk for premature birth. This project aims to develop an intravaginal ring device to supply bioidentical progesterone to the cervix and vaginal epithelia of at-risk women, to prevent preterm birth and improve neonatal outcomes.
Project Terms: Advanced Development; Affect; American College of Obstetricians and Gynecologists; Biological Sciences; Brain; capsule; Centers for Disease Control and Prevention (U.S.); Cervix Uteri; Child; Clinic Visits; Clinical Research; clinical risk; Collaborations; comparative; cost; Country; Data; Devices; Diagnosis; Disease; Dose; Drug Kinetics; Economic Burden; Ensure; Epithelial; Epithelium; Face; Female; first-in-human; Foundations; Gel; Gold; Health; Health Sciences; healthy pregnancy; Hearing; high risk; High Risk Woman; Hormones; improved; In Vitro; in vivo; Infant Mortality; Infection; Inflammation; Intramuscular Injections; Laboratories; Length of Stay; liquid chromatography mass spectrometry; Lung; Maternal-fetal medicine; Measures; Medical; meetings; Methods; Necrotizing Enterocolitis; neonatal outcome; novel; off-label use; open label; Oregon; Outcome; Patients; Pharmaceutical Preparations; Pharmacology; Phase; phase III trial; Postmenopause; pre-clinical; preclinical study; Pregnancy; Pregnancy Outcome; Pregnant Women; premature; Premature Birth; Premature Infant; prevent; Prevention; primary endpoint; Production; Progesterone; Property; Property Leasing; Quality Control; Reporting; respiratory distress syndrome; Risk; Risk Factors; Safety; Second Pregnancy Trimester; Self Administration; skills; social; Societies; stability testing; standard care; Supplementation; Survivors; System; Technology; Testing; United States; United States National Institutes of Health; Universities; Vagina; Vaginal Gel; Vaginal Ring; Vision; Woman; World Health Organization
