Hormone-Free Prebiotic Muco-Adhesive Gels To Treat Vaginal Atrophy in Post-Menopausal Women

PROJECT ABSTRACT/SUMMARY
Vaginal Atrophy (VA), a component of Genitourinary Syndrome of Menopause, is a chronic and progressive
condition that affects approximately 50% of post-menopausal women due to estrogen deficiency. Without
treatment, symptoms such as vaginal dryness, burning, discharge, itching, irritation, painful intercourse, and
recurrent urinary tract infections worsen over time. This results in an adverse impact on the quality of life, sexual
health, and emotional well-being of affected women. About 1.1 billion women worldwide are projected to be in
menopause by 2030. In the United States, 50 million women are currently in menopause and approximately 2.2
million women are projected to enter menopause yearly. Therefore, given the growing population of post-
menopausal women, many women are potentially at risk for VA.
The first-line pharmacologic treatment recommended for VA is vaginal estrogen therapy. However, despite its
effectiveness, most women refuse hormonal therapy due to concerns about side effects associated with
estrogen therapies, such as thromboembolic disorders, dementia, and cancer. Alternatives such as vaginal
lubricants and moisturizers usually provide only short-term relief, and do not treat the underlying condition. In
addition, though non-ablative laser or thermal intra-vaginal devices may be effective, they are relatively
expensive and are not FDA-approved for treatment of VA due to a insufficient safety and efficacy data.
Our company, Moremmé, is developing a patent-pending combination of hormone-free natural bioactives
loaded in a novel prebiotic mucoadhesive gel delivery system for intravaginal drug delivery. These bioactives
synergistically address key symptoms of VA by hydrating and repairing the vaginal wall while keeping the vaginal
microbiome in homeostasis. We demonstrate that within a range of effective concentrations, our formulations
are non-toxic to cultured human vaginal cells and promote production of proteins that help rebuild the vaginal
wall. The overall objective of this proposal is to test and establish the efficacy of our formulations in
reversing signs of VA in vivo. To achieve this, Aim 1 will optimize bioactive loading and release from the gel
formulations. Aim 2 will assess safety and tolerability of the optimized formulation prototypes using a 3-D human
vaginal tissue model, while Aim 3 will determine efficacy of the formulations in reversing signs of VA in a rodent
model. Upon successful completion of this Phase I project, we will have optimized loading and release of
bioactives from the gel matrix, determined formulation tolerability in human vaginal tissues, and established
effectiveness in treatment of VA in vivo. This work will provide preliminary data and proof of concept to support
a future Phase II SBIR application for product development and commercialization activities for a hormone-free
vaginal suppository for treatment of VA in post-menopausal women. This will ultimately offer a viable alternative
for millions of aging women who desire a safe, effective, and hormone-free alternative for treatment of VA.

Grant Number: 3R43AG084468-02S1
NIH Institute/Center: NIH
Principal Investigator: Janet Akande-Dokun