The vaginal microbiome in women’s health

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Precision medicine, also known as personalised medicine, has transformed science and healthcare over the past few decades. Until recently, developments have been focused on oncology, but women’s sexual and reproductive health is now garnering interest from smaller companies keen to make advances in this emerging area. 

“We've only really scratched the surface of differences between men and women's biologies,” observes Mané Mikayelyan, a project leader at DeciBio, a precision medicine-focused strategy consulting firm based in the U.S. Mikayelyan has a special interest in personalised medicine in women’s health and points out that gender-specific pharmacodynamics/pharmacokinetic differences means there is an unmet need for diagnostics and treatment for women. 

“It's about tailoring treatment and care options to women’s unique biology,” she continues. “That could be genetic biomarkers, clinical history, risk factors, and the microbiome. It's important to shift away from one size fits none. If you can pick the right intervention at the right time, then you can personalise that care and maximise the effectiveness of the treatment.” 

Newborn responses to illness are much more stereotyped than adults as many of their organ systems are just starting to work. As a result, their “responses to disease are often the same despite having different causes, again making diagnosis more difficult,” Kingsmore adds.

Our bodies are inhabited by a delicate balance of microorganisms and the vaginal environment is no exception. The composition of the vaginal microbiome can vary widely between individuals and over time; it influences women's reproductive health, immune responses, and overall wellbeing. Imbalances can lead to bacterial vaginosis (BV), thrush, and urinary tract infections and may also influence fertility. 

“We’ve seen a move towards better multiplex molecular diagnostics and DTC products which claim to help women get a better understanding of their vaginal microbiome using direct-to-consumer testing,” says Mikayelyan. 

She suggests this may eliminate trial-and-error treatment for conditions with otherwise similar symptoms, such as bacterial vaginosis and yeast infections (vaginal thrush), which women may choose to treat with over-the-counter medications. 

US companies Everlywell, Evvy, Juno Bio and Microgenesis offer kits for home-testing the vaginal microbiome and to detect thrush and BV.  Gedea is looking to develop the first antibiotic-free treatment that both treats and prevents BV, and Osel, Luca Biologics and Concerto biosciences are making strides in biologics that target the vaginal flora. As the vaginal microbiome has also been linked to other conditions including endometriosis, infertility, and pregnancy complications, some startups such as Danish company Freya Biosciences are focused on creating immunotherapeutic treatments.  

“The mission for companies like Freya Biosciences is interesting and unique,” says Mikayelyan. “They are acknowledging that the microbiome, immune system, and women’s reproductive health conditions are linked. It is not fully personalised to the individual yet by any means, but this type of research and innovation is where precision medicine as it relates to the vaginal microbiome is beginning to take shape.” 

Other areas of women’s reproductive health are further ahead in terms of the precision medicine approach. Significant DTC developments are now aiding fertility tracking, and AI has improved oocyte and embryo selection and specimen management systems.  

The diagnosis and treatment of endometriosis (which can cause infertility) is an area that numerous pharma startups are involved in says Mikayelyan, with “most taking an RNA-based approach. Some are also leveraging single-cell or unique collection methods, such as tampon-style devices.” 

Polycystic Ovary Syndrome is also of interest to start-ups who are interested primarily in researching innovative treatment options.  

“Celmatix and HBM Alpha Therapeutics are looking at advancing antibody therapies, whereas others are taking a medical device approach, such as May Health with an ovarian ablation strategy,” explains Mikyelyan. 

Significant developments have also been made in precision medicine to reduce pregnancy and perinatal complications, improve contraception, and assist with menopausal symptoms. Companies such as Oviva Therapeutics are also aiming to target the cause of menopause (ovarian aging) and the potential is there to develop a more personalised approach to managing a woman’s reproductive journey from menstruation to menopause. 

One of the key obstacles in delivering precision medicine to women is access to care. 

“You can have cutting edge tech and innovation,” observes Mikyelyan, “but without infrastructure in place to disseminate that tech, it won't reach the patients. That’s a political and sociological issue on a global scale.” 

But perhaps the biggest challenge to date has been the lack of focused research and funding.  

“That’s slowly changing,” says Mikyelyan. “There’s been more in the digital health space recently than in diagnostics and pharmaceuticals. But we’re starting to see more innovation in diagnostics and pharma with companies like Organon, a global healthcare company with a portfolio of therapies and products in women’s health.” 

While big investors can see the potential in innovative digital technology, they want to see more evidence before investing in ‘personalised’ vaginal microbiome treatments. Start-ups such as Freya Biosciences are reticent to call their work precision medicine at this early stage which is understandable. 

The vaginal microbiome is constantly changing day to day, throughout the menstrual cycle, and with pregnancy and menopause, because of hormonal fluctuations. 

“That makes it hard to design treatments,” says Mikayelyan. “You see that with trial results; there can be a lot of variability and it’s difficult get reproducible results which are what’s required to take to the U.S Food and Drug Administration to get approved.” 

Clearer guidelines are needed for microbiome-related biomarkers and with regards to the safety and efficacy of potential treatments. While numerous companies now offer personalised assessment of the vaginal microbiome, more research is needed to interpret these results in a meaningful way. Without a more nuanced understanding of what constitutes a healthy vaginal microbiome for each individual, it will be difficult to make advances in personalised treatments. 

“The problem is with more chronic and recurrent vaginal conditions,” says Mikayelyan. “Do differences in individual microbiomes cause that? We need to know in order to create precision treatments. That is a key area that still needs to be solved.” 

Research and investment in women’s health is steadily increasing, with clinical trials increasing tenfold over the last 20 years. However, Mikayelyan believes it is likely to take five to 10 years before there is major investment in smaller start-ups researching the vaginal microbiome and precision medicine. 

“Once the oncology market is saturated, investors are going to have to turn somewhere. I'm hoping that within the decade, preferably sooner, it'll be a no brainer to invest in precision medicine for women because of all the research that's being done by the smaller startups. There's a very clear market opportunity in many areas.”