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

基本信息

  • 批准号:
    10459077
  • 负责人:
  • 金额:
    $ 25.95万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 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

项目摘要

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MM008的首选设计特征识别

项目成果

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Keiichiro Kushiro其他文献

Keiichiro Kushiro的其他文献

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{{ truncateString('Keiichiro Kushiro', 18)}}的其他基金

Highly Acidifying Intravaginal Rings with Lactobacillus Probiotics to Treat Bacterial Vaginosis
含乳酸菌益生菌的高度酸化阴道环可治疗细菌性阴道病
  • 批准号:
    10699458
  • 财政年份:
    2023
  • 资助金额:
    $ 25.95万
  • 项目类别:
Fast dissolving antibody tablets for preventing vaginal HSV transmission
用于预防 HSV 阴道传播的快速溶解抗体片
  • 批准号:
    10547476
  • 财政年份:
    2022
  • 资助金额:
    $ 25.95万
  • 项目类别:
Development of a qualified pharmacokinetic bioassay to support preclinical and clinical studies of MM-008, a non-hormonal contraceptive antibody
开发合格的药代动力学生物测定法以支持非激素避孕抗体 MM-008 的临床前和临床研究
  • 批准号:
    10459074
  • 财政年份:
    2022
  • 资助金额:
    $ 25.95万
  • 项目类别:
Capsule-intravaginal ring for sustained release of antibodies for non-hormonal contraception and vaginal protection against HIV
胶囊阴道环,用于持续释放抗体,用于非激素避孕和阴道艾滋病毒保护
  • 批准号:
    9799170
  • 财政年份:
    2021
  • 资助金额:
    $ 25.95万
  • 项目类别:
Capsule-intravaginal ring for sustained release of antibodies for non-hormonal contraception and vaginal protection against HIV
胶囊阴道环,用于持续释放抗体,用于非激素避孕和阴道艾滋病毒保护
  • 批准号:
    10381449
  • 财政年份:
    2021
  • 资助金额:
    $ 25.95万
  • 项目类别:

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