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

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 rt16-fold more potent than the best anti-sperm IgG known in the literature, aggulutinate sperm even down to lt100 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.