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.

There is a large unmet medical need for an efficient and highly accessible solution that can simultaneously treat and prevent BV and VVC, while removing the abuse of antibiotic and antimycotic drugs to avoid further antimicrobial resistance. The inefficacy of current solutions is demonstrated by the huge burden that BV/VCC bring to the society in terms of economic expenses (more than €3.8Bn annually), preterm births (5.4M per year), the huge prevalence of both diseases (more than 500M cases per year) and the deteriorated QoL for women. Gedea has developed pHyph, a patented pessary that due to its safe profile will be highly accessible as a first line OTC solution. pHyph is an antimicrobial-free dual solution with a new mode of action that targets both the treatment and prevention of BV and VVC, without the need of pathogen identification. pHyph will be commercialized as an OTC product in pharmacies and drug stores – where 90% of women with VI look for a treatment to the infection. The business model targeted for pHyph is a well-established and successful B2B2C model for this type of product. Our business model is highly scalable via planned partnerships with distributors and pharma companies, that will facilitate accelerated commercial deployment & scale up of our business throughout Europe & beyond. Gedea core team is composed by 9 persons with over 250 years of experience combined, including experts in clinical research, bioorganic chemistry, regulatory affairs, marketing, and business development. The company received the award "Rapidus Company of the Year" and appeared on Labiotech's list "The 20 European Biotech Companies to Watch in 2022". During this project, Gedea will perform the necessary clinical trials, CE-Mark Certification and pre-market activities to commercialize pHyph (TRL 9 by 2026). In order to do so, Gedea requires an estimated expenditure of €11.9M, which is requested to the EIC through both Grant and Equity fund.

This project will develop a business plan to guide clinical validation and commercialization of pHyph, a novel treatment targeting vaginal yeast and bacterial infections. Bacterial vaginosis (BV) and vulvovaginal candidiasis (VCC) are common vaginal infections caused by bacteria (often Gardnerella) or yeast (a fungus) called Candida. 450 million globally experience at least 4 vaginal bacteria or Candida infections each year. It causes significant discomfort, adversely affects quality of life and is associated with heavy socioeconomic burden. To date, all treatments are limited to antifungals and antibiotics that show low efficacy and high relapse rate. With prolonged usage, misdiagnosis, and overconsumption, there is a high incidence of drug resistance, which the WHO considered one of the biggest threats to global health. Gedea has developed a vaginal tablet that contains the natural substance Glucono-δ-lactone (GDA), which switches Candida towards a benign yeast form, restores vaginal pH and disrupts the Candida and bacteria biofilm without causing treatment resistance. The yeast is removed through vaginal discharge. Since this is an antibiotic-free treatment, healthy bacteria that normally keep Candida at bay are also not removed and therefore a low relapse rate is expected with the use of pHyph. The product’s key feature lies in its ability to treat both yeast and bacterial infections and its use as both a preventative and curative treatment. These features are unmet by any other product on the market. Preclinical research performed to date strongly supports pHyph’s novel mechanism to treat vaginal infections, reduce recurrent infections and eliminate the need for antibiotics/antimicrobials. The proposed project will further prepare pHyph for a clinical trial. SME Instrument funding will allow Gedea to close the gap on the road towards commercialisation.