An Isotonic Biome-Friendly Vaginal Moisturizer to Relieve Genitourinary Menopausal Symptoms

An Isotonic Biome Friendly Vaginal Moisturizer to Relieve Genitourinary Menopausal Symptoms SUMMARYPostmenopausalPMwomen suffer from vaginal atrophywith a loss of natural moisture and elasticityas well as vaginal dysbiosis and increased vaginal pHcollectively known as the Genitourinary Syndrome of MenopauseGSMSymptoms of GSM include vaginal drynessburningirritation and malodoras well as sexual dysfunctionThere aremillion such women in the US and overof these women have signs of GSM at menopauseSymptoms progress over time and require continual treatmentCurrent vaginal lubricants and moisturizersVLandamp Mare first line therapies for GSM but they can cause vaginal mucosal damage and inhibit healthy lactobacillus growthbased on physiochemical properties and formula excipientsThere is an unmet need for a VLandamp M that relieves symptoms of GSM while minimizing disruption to the vaginal ecosystemThe overall goal of this proposal is to develop a biome friendlymoisturizinglubricating and pH balancing vaginal gel for improved GSM symptom relief in PM womenFairhaven Health specializes in womenandapos s healthincluding an isotonic vaginal product lineA VLandamp M gel prototype has been developedSAGEto improve GSM symptom relief by reducing immunemucosaland biome toxicitycompared to existing productsSAGEandapos s proprietary formula has been preliminarily found to cause less mucosal irritation and less disruption to healthy lactobacillus versus existing VLandamp MA novel unit dose applicator system has been designed to deliver the sterilepreservative free SAGEThe following PhaseAims will move SAGE towards commercializationAimFinalize Formula andampCompare Functional PropertiesAStudies will define the final SAGE formula and mixing protocols to ensure physiochemical properties are retained during sterilization and stability testingBStudies will confirm key functional propertiesfor GSM symptom reliefof mucoadhesionlubricity and buffering capacity of SAGE versus competitive productsAimVaginal Biome Compatibility Testing Evaluation of SAGE in this Aim will be performed by the Laboratory of Genital Tract Biology at Brigham and Womenandapos s HospitalAStudies will evaluate the impact of SAGE and competitive products on valuable vaginal Lactobacillus species of the healthy human vaginaBA human in vitro model study will monitor markers of cell damage and immunotoxicity following contact of bacteria colonized vaginal epithelia with SAGE versus competitive VLandamp MA final SAGE formula will be acceptable for a PhaseSBIR if it is equivalent or superior to other VLandamp M in functional propertiesand superior over competitors in epithelium associated lactobacillus colony forming unitsepithelial integrityand or markers of epithelial disruption and inflammatory activityThe team behind SAGE has combined expertise in clinical and experimental vaginal biologyvaginal product developmentregulatory clearancesterile manufacturing of gels and commercial sales in womenandapos s vaginal products An Isotonic Biome Friendly Vaginal Moisturizer to Relieve Genitourinary Menopausal Symptoms NARRATIVE Postmenopausal women suffer from vaginal atrophywith a loss of natural moisture and elasticityas well as a rise in vaginal pHcausing the Genitourinary Syndrome of MenopauseGSMwith symptoms of vaginal drynessburningirritation and malodoras well as sexual dysfunctionCurrent vaginal lubricants and moisturizersVLandamp Mare first line therapies for GSM but they can cause vaginal mucosal damage and harm healthy lactobacillusbased on their formulas and chemistryThe goal of this proposal is to develop a biome friendlymoisturizinglubricating and pH balancing vaginal gel for improved GSM symptom reliefusing a state of the art human invitro model to evaluate markers of cell damage and immunotoxicityas well as lactobacillus growth for the new gel versus existing VLandamp M