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Vaginal ring for sustained release of lactic acid to prevent bacterial vaginosis and associated health risks

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI157652-01
Agency Tracking Number: R43AI157652
Amount: $306,500.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA19-272
Solicitation Year: 2019
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-03-01
Award End Date (Contract End Date): 2022-02-28
Small Business Information
Carrboro, NC 27510-2504
United States
DUNS: 079756959
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (410) 336-6598
Business Contact
Phone: (248) 982-7470
Research Institution

Project Summary
Millions of women in the U.S. suffer from bacterial vaginosis (BV), a vaginal condition initiated by marked
overgrowth of polymicrobial bacterial populations that can suppress protective lactobacilli. Healthy lactobacilli
secrete lactic acid (LA) that acidifies the vagina and acts as a broad-spectrum microbicide that protects
against many types of pathogens and also can suppress polymicrobial communities of BV species that
produce little or no lactic acid. We do not know what initiates episodes of BV, but we do know that BV strongly
increases risks of many sexually transmitted infections including HIV, and increases risks of premature births.
At any given time, about 1/3 of sexually active women in the U.S. and world-wide have BV. Antibiotics can
provide transient relief from the foul-smelling discharge caused by BV but they do not prevent BV from
recurring (sometimes at a frequency up to twice a month). There is no product on the market that can provide
sustained protection against BV. We and others have shown that LA can potently inactivate many types of BV-
associated bacteria as well as many types of pathogens that cause sexually transmitted infections. Since LA is
abundant in the healthy vaginas of women with protective lactobacilli, it has the potential to provide a safe
nontoxic microbicide. We have recently determined the rate at which healthy lactobacilli continuously produce
LA and hence for the first time know the rate at which lactic acid should be supplied to the vagina to treat and
prevent BV. This has enabled us to develop an LA-releasing intravaginal ring (LA-IVR) that can provide
sustained release of LA over 30 days at the rate needed to treat and prevent BV while not suppressing healthy
lactobacilli. Through careful selection of polymers and formulation design, we have shown that we can tune the
release rates of LA from various polymeric matrices, and achieve sustained release of LA. Building on our
promising pilot work, we seek in Aim 1 to optimize our lead LA-IVR formulation, and perform various
characterizations including LA release rates over time, hydrophobicity, and mechanical properties (elasticity,
compressibility). We will then fabricate a macaque LA-IVR, and in Aim 2 test whether sustained release of LA
by this IVR can suppress BV-like bacterial species in pigtail macaques. Successful demonstration of safety and
efficacy in this highly relevant large animal model would support advancing Mucommune’s LA-IVR through
IND-enabling activities. The simplicity of our LA-IVR design ensures both ease of production and likely very low
manufacturing costs of the eventual product, which in turn should maximize potential public health impact and
commercial viability of the product both in the U.S. and in low and middle income countries worldwide.
(26 lines)Project Narrative
Bacterial vaginosis (BV) is a frequently recurring vaginal condition that suppresses protective lactobacillus
bacteria and greatly increase risk of sexually transmitted infections and adverse pregnancy outcomes. To meet
the urgent need for sustained protection against BV, Mucommune is developing an intravaginal ring (LA-IVR)
that will continuously release lactic acid (LA) for over 30 days at a rate designed to safely suppress BV-causing
bacteria while not suppressing healthy protective lactobacilli. The LA-IVR can be produced at low cost, and its
successful development would establish an affordable and effective method for protecting millions of women
from BV in the U.S. and worldwide.

* Information listed above is at the time of submission. *

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