User-based identification of preferred design features for MM008, a non-hormonal contraceptive vaginal ring

基于用户的非激素避孕阴道环 MM008 的首选设计特征识别

• 批准号: 10459077
• 负责人: Keiichiro Kushiro
• 金额: $ 25.95万
• 依托单位: MUCOMMUNE, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10459077
• 关键词: Address; Adherence; Adoption; Antibodies; Antigen Targeting; Antigens; Appearance; Behavior; Behavioral; Benefits and Risks; Binding; Biomanufacturing; Characteristics; Clinic; Clinical Trials; Coitus; Color; Complex; Contraceptive Agents; Contraceptive Usage; Contraceptive methods; Development; Devices; Dose; Effectiveness; Engineering; Enrollment; Ensure; Esthetics; Evaluation Studies; Excision; Exercise; Exogenous Hormone Therapy; Federal Government; Feedback; Female; Fertility; Focus Groups; Formulation; Goals; Group Meetings; Hand; Hormonal; Hormones; Hospitals; Human; Immunoglobulin G; Innovation Corps; Institutional Review Boards; Interview; Lead; Literature; Measures; Methods; Monoclonal Antibodies; Mucous body substance; Outcome; Participant; Patient Recruitments; Perception; Persons; Pharmacology; Pregnancy; Process; Property; Provider; Reporting; Research Design; Research Personnel; Safety; Sensory; Sheep; Site; Sperm Motility; Spermatozoa antibody; State Government; Surveys; System; Target Populations; Thinking; United States National Institutes of Health; Vagina; Vaginal Ring; Vaginal delivery procedure; Variant; Woman; Work; base; capsule; cell motility; comparative; cost; demographics; design; egg; experience; in vivo; insight; male; physical property; preference; prevent; product development; programs; prototype; reproductive tract; satisfaction; side effect; sperm cell; success; synergism; unintended pregnancy; uptake; willingness

User-based identification of preferred design features for MM008, a non-hormonal contraceptive vaginal ring Project Summary Nearly half of all pregnancies in the U.S. are unintended, and most occur in women who are not using contraceptives. There are diverse reasons for not using contraceptives; one common reason is that many women have a strong aversion to using exogenous hormones due to real and perceived side effects. It is likely that contraceptive use and satisfaction would substantially increase if there was a non-hormonal, user- controlled contraceptive method that did not require use immediately prior to intercourse, nor daily dosing. We believe we can create such a non-hormonal contraceptive based on vaginal delivery of an anti-sperm monoclonal antibody (mAb) that agglutinates and traps sperm in mucus, thereby preventing sperm from reaching the egg. We have developed an exceptionally potent mAb, MM008, that target a well characterized and validated antigen target universally present on all human sperm. MM008 is highly homogeneous and stable, and can be produced at very high yields using conventional biomanufacturing processes. More importantly, MM008 is >16-fold more potent than the best anti-sperm IgG known in the literature, aggulutinate sperm even down to <100 ng/mL, and can reduce progressively motile sperm by 99.9% in the sheep vagina within 2 mins at a dose of just 33 µg per sheep. We have since shown that we can steadily release MM008 from a proprietary capsule-intravaginal ring (IVR) system that sustains highly effective concentrations of MM008 in the sheep vagina for over 20 days (more than adequate to cover the fertility window in most women). These highly promising results motivated us to actively advance MM008-IVR into the clinic. Our goal is to advance a product that suits the contraceptive needs for many women, with both high efficacy and high user adoption. Thus, it is important for us to rigorously investigate user pereceptions and preferences that could impact their willingness to try or use the product. In this proposal, we seek to respond to the RFA HD-22- 019 to identify preferred use characteristics (PUC) and investigate the user sensory perceptions and experiences for MM008-IVR. In Specific Aim 1, we will conduct mixed method integrative design study to examine the perceptibility and PUCs of non-hormonal contraception, including an in mano comparative assessment of variants of our MM008-IVR. These user insights will be investigated initially through quantitative online survey, and then followed by in-person focus groups. In Specific Aim 2, we will conduct a short-term user experience study to evaluate the perceptibility and related PUC following vaginal insertion and use of a non-medicated IVR identical in appearance and physical properties to the preferred MM008-IVR from Aim 1. Successful completion of the proposed work will help ensure we are advancing a product that can meet the contraceptive needs and preferences of millions of women in the U.S. and worldwide.

基于用户的MM008首选设计功能的标识，这是一种非激素避孕药 阴道环 项目摘要 美国几乎一半的怀孕是意想不到的，大多数发生在不使用的女性中 避孕药。潜水员的原因是不使用避孕药具；一个常见的原因是很多 由于真实和感知的副作用，妇女对使用外源恐怖症有很大的厌恶。很可能 如果存在非激素，用户 - 受控的避孕方法，在性交前不需要立即使用，也不需要每天给药。我们 相信我们可以基于阴道递送的抗植物来创建这种非荷尔蒙避孕药 单克隆抗体（mAb），会在粘液中凝结并捕获精子，从而防止精子 到达鸡蛋。我们已经开发了一个具有异常潜在的mab mm008 并验证了所有人类精子上普遍存在的抗原靶标。 MM008高度均匀， 稳定，可以使用常规的生物制造过程以很高的产量生产。更多的 重要的是，MM008比文献中已知的最佳抗卵形IgG高16倍 精子甚至降至<100 ng/ml，可以在绵羊阴道中逐步减少99.9％ 在2分钟内，每只绵羊的剂量仅为33 µg。从那以后，我们表明我们可以稳步发布MM008 从专有胶囊内膜环（IVR）系统中保持高效浓度 绵羊阴道中的MM008超过20天（足以覆盖大多数生育窗口 女性）。这些高度有希望的结果促使我们积极将MM008-IVR推进到诊所。我们的目标 是推进适合许多女性避孕需求的产品，这些女性既高效率又高 用户采用。这对我们而言，重要的是要严格研究用户的看法和偏好 可能会影响他们尝试或使用该产品的意愿。在此提案中，我们试图回应RFA HD-22- 019识别首选使用特征（PUC）并研究用户感官感知和 MM008-IVR的经验。在特定的目标1中，我们将进行混合方法集成设计研究 检查非荷尔蒙避孕的感知和PUC，包括Mano比较 评估我们的MM008-IVR的变体。这些用户见解最初将通过定量研究 在线调查，然后是面对面的焦点小组。在特定的目标2中，我们将进行短期 用户体验研究以评估阴道插入和使用后的可感知性和相关PUC 来自AIM 1的非物质IVR外观和物理性质与首选的MM008-IVR相同。 成功完成拟议的工作将有助于确保我们推进可以满足该产品的产品 美国和全球数百万妇女的避孕需求和偏好。