Project description
Vaginal invaders may have met their match
We hear a lot these days about the gut microbiome: all the fungi, bacteria, viruses and protozoa and their genetic material in the gastrointestinal tract. While we know how important the gut microbiome is to sickness and health, the vagina has its own community of microorganisms, and once again, imbalance and invasion can wreak havoc. Bacterial vaginosis (BV) and vulvovaginal candidiasis (VCC) are caused by bacteria and fungi, respectively. They are common conditions that can recur, and drug resistance is leading to low efficacy and even higher recurrence. The EU-funded NEFERTITI project is bringing a revolutionary new treatment to market, a vaginal tablet whose active substance is already an approved food additive. It treats the bacterial and fungal infection equally well, and has curative as well as long-term protective effects.
Objective
Bacterial vaginosis (BV) and vulvovaginal candidiasis (VCC) are common vaginal infections caused by Gardnerella and other anaerobic bacteria. or by Candida fungi. The infection can occur once - the acute form - or recur repeatedly over the course of a year. About 68m women in Europe and the US are infected each year. They cause intense physical discomfort, adversely affects quality of life and have heavy socioeconomic costs.
Many women opt to self-treat with non-prescription over-the-counter antifungals which fail because the causative microorganism has not been properly identified. Antibiotics for BV are encountering increasing levels of drug resistance. Combination of misdiagnosis, misuse, non-compliance, overconsumption leads to low efficacy and high recurrence rates for both VVC and BV.
NEFERTITI FTI will demonstrate in clinical trials a pessary based on glucono-δ-lactone –trademarked as pHyph - as a highly effective cure for acute and recurrent BV and VVC, and as a far better alternative to antibiotics or antifungals. pHyph restores the vaginal mucosa to pH4 and disrupts Candida biofilms, promotes the proliferation of natural and protective aerobic lactobacilli, and displaces Gardnerella and other anaerobic pathogenic bacteria. pHyph is a single solution for both pathogens and infections, and with both curative and protective effects, and does not trigger drug resistance in the microbiome. These features are unmatched by any other product on the market – whether as over the counter or prescribed.
NEFERTITI FTI will also develop a post-project business plan for the rapid scale up of production and commercialisation of pHyph in Europe in 2022 as an over-the-counter product into a market for BV and VVC treatments worth €1.7bn in 2022 and will be commercialised through a major drug distributor. The same plan will also mark the regulatory steps and commercial partners needed for pHyph to reach the US market in 2024.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques.
- natural sciencesbiological sciencesmicrobiologybacteriology
- natural sciencesbiological sciencesmicrobiologymycology
- medical and health sciencesbasic medicinepharmacology and pharmacydrug resistance
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsantibiotics
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Funding Scheme
IA - Innovation actionCoordinator
223 81 Lund
Sweden
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.