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Innovative 3D Printed Intravaginal Ring AnelleO-PRO, the first Single Administration of Progesterone for Infertility

创新 3D 打印阴道环 AnelleO-PRO，首个单次注射黄体酮治疗不孕症

基本信息

批准号：
10323463
负责人：
Soumya Rahima Benhabbour
金额：
$ 86.29万
依托单位：
ANELLEO, INC.
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-19 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10323463
关键词：
3-Dimensional 3D Print Accelerated Phase Address Adherence Affect Age Animal Model Assisted Reproductive Technology Atopobium vaginae Behavioral Biological Cervical Characteristics Computer-Aided Design Contraceptive methods Couples Custom Data Development Development Plans Devices Diffusion Dimensions Drug Controls Drug Delivery Systems Drug Kinetics Drug Targeting Engineering Evaluation FDA approved Fertilization in Vitro Formulation Fostering Geometry Goals Hormone replacement therapy In Vitro Infertility Injections Intramuscular Injections Investigation Link Liquid substance Macaca Macaca nemestrina Mechanics Medical Methods Modality Modeling Molds Names Pain Patients Perception Performance Pharmaceutical Preparations Pharmacodynamics Pharmacology Phase Placebos Plasma Pregnancy Preparation Process Production Progesterone Property Quality Control Regimen Resource Development Safety Schedule Sheep Site Small Business Innovation Research Grant Small Business Technology Transfer Research Solid Supplementation Surface Surface Properties Systems Development Technology Testing Tissues Toxic effect Vagina Vaginal Discharge Vaginal Gel Vaginal Ring Woman base compliance behavior controlled release cost effective design drug release kinetics global health improved in vitro testing in vivo infertility treatment innovation innovative technologies manufacturing process mechanical properties meetings multidisciplinary novel pre-clinical preference quality assurance reproductive side effect skills stability testing treatment duration vaginal fluid

项目摘要

PROJECT SUMMARY Infertility is a global health problem. In the US alone, ~1.7 million women are treated for infertility every year. To improve infertility treatment, there is a strong need to promote patient-friendly methods for progesterone supplementation in assisted reproductive technology (ART). Intravaginal rings, which are well tolerated by women, are efficacious for contraception and hormone replacement therapy, and have high patient compliance, are now in development for ART. However, developing effective IVRs to deliver progesterone beyond 7 days is challenging due to limitations of current engineering processes, and difficulty in controlling release rates, thus mandating drug-specific customized IVR designs. Our goal is to address these limitations by revolutionizing the engineering and manufacturing processes for intravaginal rings, using a state-of-the-art 3D printing process known as continuous liquid interface production (CLIP™). Using the automated CLIP process, we can engineer and manufacture IVRs with surface geometries not achievable with traditional injection molding or extrusion, which help control drug release. CLIP enables us to precisely fine-tune diffusion and release of drugs, to achieve near complete release, and independently control IVR mechanical properties. Importantly, using CLIP, we can manufacture IVRs that provide sustained release of progesterone to cover the entire ART treatment period in a rapid and cost-effective single-step process. In this Phase II SBIR project, we propose to build on our existing data from Phase I to optimize a progesterone IVR named AnelleO-PRO, test its efficacy in a relevant macaque model, and conduct IND-enabling studies to support an IND-application. We will implement comprehensive rational IVR design, using the highly relevant preclinical sheep and macaque models to characterize the safety, pharmacokinetic profiles, and efficacy of optimized AnelleO-PRO. This multidisciplinary, cutting-edge approach will develop a unique and highly innovative 3D printed CLIP IVR – AnelleO-PRO, delivering progesterone in a long-acting, single administration treatment of infertility.

项目总结