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.

基于用户的非激素避孕药MM 008首选设计特征识别 阴道环 项目摘要 在美国，近一半的怀孕是意外的，大多数发生在没有使用避孕药的妇女身上。 避孕药不使用避孕药具的原因多种多样;一个常见的原因是，许多人 由于真实的和感觉到的副作用，妇女对使用外源激素有强烈的反感。很可能 如果有一个非激素的使用者， 控制避孕方法，不需要在性交前立即使用，也不需要每天给药。我们 我相信我们可以创造出一种基于阴道输送抗精子的非激素避孕药 一种单克隆抗体（mAb），它能凝集精子并将其捕获在粘液中，从而阻止精子从粘液中排出。 到达鸡蛋。我们已经开发了一种非常有效的mAb，MM 008，它靶向一种已经充分表征的 并验证了普遍存在于所有人类精子上的抗原靶标。MM 008具有高度均匀性， 稳定，并且可以使用常规的生物制造方法以非常高的产率生产。更 重要的是，MM 008比文献中已知的最好的抗精子IgG--aggulutinate--的效力高>16倍 在绵羊阴道中，精子的运动性可降低99.9% 每只羊仅需33微克的剂量即可在2分钟内完成。我们已经证明，我们可以稳定地释放MM 008 从一个专有的胶囊阴道环（IVR）系统，维持高效浓度的 MM 008在绵羊阴道中持续20天以上（在大多数情况下， 妇女）。这些极具前景的结果促使我们积极将MM 008-IVR推向临床。我们的目标 是推出一种适合许多女性避孕需求的产品，既高效又高效 用户采用。因此，对我们来说，严格调查用户的偏好和偏好是很重要的， 可能会影响他们尝试或使用该产品的意愿。在本提案中，我们寻求回应RFA HD-22- 019确定首选使用特征（PUC）并调查用户感官知觉， MM 008-IVR的经验。在具体目标1中，我们将进行混合方法综合设计研究， 检查非激素避孕的可感知性和PUCs，包括一项手内比较 评估我们的MM 008-IVR的变体。这些用户洞察力将通过定量分析进行初步调查。 在线调查，然后是面对面的焦点小组。在具体目标2中，我们将进行短期 用户体验研究，以评价阴道插入和使用后的感知性和相关PUC 外观和物理性质与目标1中的优选MM 008-IVR相同的非药物IVR。 成功完成拟议的工作将有助于确保我们正在推进一个产品，可以满足 避孕需求和偏好的数百万妇女在美国和世界各地。