A novel intravaginal ring technology featuring the sustained release of natural progesterone for the prevention of preterm birth in at-risk women

在美国，十分之一的婴儿是早产的。怀孕越早，婴儿出生的时间越长 S/他可能会长时间住院，以及严重的健康并发症，如呼吸道并发症 窘迫综合征、坏死性小肠结肠炎、视力问题和感染。有前科的女性 早产和孕中期被诊断为宫颈短小的妇女早产的风险很高，以及 通常会开一种黄体酮产品来降低这种风险。目前只有两个将军 为有早产风险的妇女提供的黄体酮产品，每种产品都有与以下方面相关的缺陷 药效多变，使用方便。此外，现有的黄体酮产品都没有获得批准 来自联邦药物管理局，用于被诊断为宫颈较短的孕妇。为了提高 DaréBioscience是针对有一个或两个临床早产风险因素的女性的治疗选择 推动一种名为DARE-FRT1的新型阴道内环的开发。DARE-FRT1为女性提供 对患者友好的缓释孕酮产品，在体内提供相对稳定的药物水平 靠近宫颈，孕激素的作用调节炎症、收缩和其他活动 与劳动有关的。体内临床前研究表明DARE-FRT1缓慢释放生物等效性 黄体酮至少持续14天。在这些坚实的基础研究的基础上，我们的目标是：(I)完成IND- 支持体外DARE-FRT1产品稳定性研究，以确保与产品的一致性和(Ii)评估 首例人类临床研究中不同剂量DARE-FRT1的药代动力学比较。因此，敢不敢- FRT1有望成为第一种简单、安全、方便的延长妇女妊娠期的方法。 增加早产风险，改善整体健康状况，降低婴儿死亡率。

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.