Leveraging the Natural Biology to Enhance Outcomes
Up to now, the impact of the vagina’s unique bioenvironment on successful outcomes has been largely overlooked in the development of effective therapeutics.
At Ansella Therapeutics we see a unique opportunity to enhance the efficacy and safety of vaginal medicines by applying a biomimetic approach to this highly specific and sophisticated organ.
The Challenge
A Formidable Challenge
The nature and dynamic properties of vaginal mucous membranes presents significant challenges to per vaginam formulation. Any disruption of the unique biophysiology comprised of an iso-osmolar, acid pH environment with unique biochemistry to encourage a symbiosis with commensal bacterial, has the potential to work against the intended therapeutic outcome, even causing more harm than good.
- Acidic pH created by commensal bacteria to discourage unwanted microorganisms.
- A moist lubricated environment that utilizes an aglandular system of “Tight Junctions” to opens and closes gaps between cells that allow the influx of protecting, lubricating fluids from the highly vascular tissue.
- These active Tight Junctions, mean that mucous membranes also have the ability to absorb many compounds directly into blood stream. This dramatically limits the number of suitable materials available for formulation without risk of systemic toxicities.
Vaginal Platform
Pioneering a New Approach for Vaginal Therapeutics
Ansella Therapeutics is developing a range of treatments that focus on Women’s Health including Menopause, Vaginal mucositis, Endometriosis, Uterine Fibroids and vaginal Infection.
Ansella Therapeutics is initially focused on developing products for the treatment of symptoms and the underlying pathophysiology of vulvovaginal atrophy (VVA), a common post-menopausal medical condition caused by declining levels of estrogen.
Declining levels of estrogen cause (1) a thinning of the superficial cells and stratified squamous epithelial cells that line the vaginal mucosa and (2) a decrease in squamous epithelial glycogenation, resulting in a decrease of exfoliated, glycogenated cells.
Glycogen is an important biomolecule that is responsible for maintaining vaginal health, as the conversion of glycogen to lactic acid by commensal Lactobacilli is essential for ensuring epithelial barrier integrity and maintaining a healthy, low vaginal pH. Further, declining estrogen levels also leads to decreased vulvovaginal blood flow, decreased mucus production, and decreased vaginal lubrication.
While vaginal lubricants/moisturizers and hormone replacement therapies exist to treat VVA symptoms and pathophysiology, respectively, these products have traditionally been created with a complete disregard for the underlying physiology of the vagina.
For example, the majority of vaginal lubricants are hyperosmotic and hyperosmolality has been shown to negatively impact the integrity of the vaginal epithelium, giving rise to increased risk of sexually transmitted infections (STIs).
Osmolality has a significant impact on the integrity of the vaginal epithelium.
Ansella Therapeutics set out to produce a biomimetic formulation that would help restore, recreate and support the pre-menopausal biophysiology, giving the body a chance to help itself and support (not counter) the therapeutic goal and at the same time deliver drugs to the vaginal mucosa in a safer and more effective way than traditional products.
The Biomyme V™ Platform
The Biomyme V platform comprises an isotonic, pH balanced and commensal bacteria compatible, semi-solid formulation composed of ingredients that are not absorbed into the bloodstream and are GRAS for vaginal use, including, lactic acid, glycogen, and the sterol lipid, cholesterol.
Isotonic formulation to maintain cell integrity
Biomyme V Works in Concert with the Inherent Physiology
The Biomyme V platform is unique for several synergistic reasons. It is an emulsified cream that is formulated to mimic the rheological properties of cervical mucus to lubricate and moisturize the vagina. The isotonicity and pH balance are governed by a lactic acid buffering system, and lactic acid has been shown to enhance cervicovaginal epithelial barrier integrity by promoting tight junction protein expression. Further, the prebiotic glycogen enables innate production of lactic acid from commensal lactobacilli.
Support Tight Junction function
Enhancing Drug Delivery
Cholesterol is special because it serves two important roles. First, it is critical for imparting emulsion stability. Second, it is the natural component of cell membranes that is responsible for regulating membrane fluidity and permeability. The second role gives rise to the formulation’s ability to deliver drugs across the vaginal mucosa.
Fluidity is defined as the ability or ease of molecules to move in the membrane. It refers to the viscosity of the cell membrane and affects the diffusion of proteins and other molecules inside cells, thus, affecting their function.This property is affected by phospholipid structure, cholesterol composition in the membrane, and temperature.
Biomyme V enhances absorption by optimizing cell membrane fluidity and permeability dynamics.
Cholesterol has a concentration-dependent effect on membrane organization. It is able to control the membrane permeability by inducing conformational ordering of the lipid chains.
