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

> **NIH NIH R43** · MUCOMMUNE, LLC · 2022 · $259,499

## Abstract

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 preference...

## Key facts

- **NIH application ID:** 10459077
- **Project number:** 1R43HD108823-01
- **Recipient organization:** MUCOMMUNE, LLC
- **Principal Investigator:** Keiichiro Kushiro
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $259,499
- **Award type:** 1
- **Project period:** 2022-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10459077

## Citation

> US National Institutes of Health, RePORTER application 10459077, User-based identification of preferred design features for MM008, a non-hormonal contraceptive vaginal ring (1R43HD108823-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10459077. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*
